Interventions for Preschool Children at High Risk for ADHD ... · Interventions for Preschool...

Interventions for Preschool Children at High Risk forADHD: A Comparative Effectiveness Review

abstractOBJECTIVES: The US Agency for Healthcare Research and Qualitysponsored a comparative effectiveness review of interventions forpreschoolers at risk for attention-deficit/hyperactivity disorder(ADHD).

METHODS: Medline, Cochrane CENTRAL, Embase, PsycInfo, and Educa-tion Resources Information Center were searched from 1980 to Novem-ber 24, 2011. Selected studies were comparative, and enrolled children,6 years with clinically significant disruptive behavior, includingADHD. The interventions evaluated were parent behavior training(PBT), combined home and school/day care interventions, andmethylphenidate use. Data were extracted by using customizedsoftware. Two independent raters evaluated studies as good, fair, orpoor by using the Effective Public Health Practice Project QualityAssessment Tool for Quantitative Studies Risk of Bias. Overall strengthof evidence (SOE) was rated for each intervention’s effectiveness,accounting for study design, systematic error, consistency of results,directness of evidence, and certainty regarding outcome.

RESULTS: Fifty-five studies were examined. Only studies examining PBTinterventions could be pooled statistically using meta-analysis. Eight“good” studies examined PBT, total n = 424; SOE was high forimproved child behavior, standardized mean difference = –0.68 (95%confidence interval: –0.88 to –0.47), with minimal heterogeneity amongstudies. Only 1 good study evaluated methylphenidate, total n = 114;therefore, SOE for methylphenidate was low. Combined home andschool/day care interventions showed inconsistent results. Theliterature reported adverse effects for methylphenidate but not for PBT.

CONCLUSIONS: With more studies consistently documenting effective-ness, PBT interventions have greater evidence of effectiveness thanmethylphenidate for treatment of preschoolers at risk for ADHD.Pediatrics 2013;131:e1584–e1604

AUTHORS: Alice Charach, MD, MSc, FRCP(C)a PatriciaCarson, BSc(H), BEd,b Steven Fox, MD, SM, MPH,c

Muhammad Usman Ali, MBBS, CCRA, MSc,b JuliannaBeckett, BA, MLIS,b and Choon Guan Lim, MBBS, MMEDd

aDepartment of Psychiatry, University of Toronto, and TheHospital for Sick Children, Toronto, Ontario, Canada; bDepartmentof Clinical Epidemiology and Biostatistics, McMaster University,Hamilton, Ontario, Canada; cCenter for Outcomes and Evidence,Agency for Healthcare Research and Quality, Rockville, Maryland;and dInstitute of Mental Health, Singapore

KEY WORDSattention/deficit hyperactivity disorder, disruptive behavior,preschool children, parent behavior training, methylphenidate

ABBREVIATIONSAAP—American Academy of PediatricsADHD—attention-deficit/hyperactivity disorderMAS—mixed amphetamine saltsPATS—Preschool ADHD Treatment StudyPBT—parent behavior trainingRCT—randomized controlled trialSMD—standardized mean differenceSOE—strength of evidence

Dr Charach participated in conceptualization of review anddesigned the key review question, was responsible forinterpretation of data analyses, and was the primary author forthe manuscript; Ms Carson was primary investigator for dataextraction, evaluation of studies and initial qualitative analyses,preparation of tables and figures, and also reviewed and revisedthe manuscript; Dr Fox was responsible for initialconceptualization of comparative effectiveness review,participated in interpretation of data, and reviewed and revisedthe manuscript; Dr Ali was responsible for final meta-analyses,and reviewed and revised the manuscript; Ms Beckett wasa primary investigator for search of gray literature and dataextraction, and also reviewed and revised the manuscript; DrLim participated in initial evaluation of studies and qualitativeanalyses, and reviewed and revised the manuscript; and allauthors approved the final manuscript as submitted.

The findings and conclusions in this article are those of theauthors, who are responsible for its content, and do notnecessarily represent the views of the Agency for HealthcareResearch and Quality. No statement herein should be construedas an official position of the Agency for Healthcare Research andQuality or of the US Department of Health and Human Services.

www.pediatrics.org/cgi/doi/10.1542/peds.2012-0974

doi:10.1542/peds.2012-0974

Accepted for publication Jan 22, 2013

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The American Academy of Pediatrics(AAP) recently updated guidelinesregarding best practice for diagnosis,evaluation, and treatment of chil-dren and youth with attention-deficit/hyperactivity disorder (ADHD). Withgrowing recognition of the lifelongburden associated with ADHD, andavailability of interventions, there hasbeen increasing emphasis on identify-ing and treating young children beforethey enter school. Reflecting researchavailable and changes in clinical careover thepastdecade, theAAPguidelinesrecommend evaluation of preschoolchildren starting at ages 4 and 5 yearsfor ADHD and other cognitive or de-velopmental conditions when childrencome for help with academic or be-havioral symptoms.1 Although accuratediagnosis of ADHD in preschool chil-dren is possible,2 making the diagnosiscan be challenging. The disorder isfrequently obscured by disruptive be-havior, including temper tantrums andaggression, and psychosocial difficul-ties, including parent-child conflict.3

Unlike older children, academic diffi-culties because of poor attention anddistractibility are rarely a primaryconcern; disruptive behavior in a pre-schooler may indicate presence ofconcurrent problems, such as opp-ositional defiant disorder, conductdisorder, anxiety disorders, or devel-opmental disabilities, as well as thechild’s response to stressors in thefamily or school/day care environment.Studies demonstrating that psychosti-mulant medications are an effectiveand safe first-line treatment of coresymptoms of ADHD in school-agedchildren4 have been used as a pre-cedent to guide treatment of youngerchildren. As a result, the number ofoff-label prescriptions for psychosti-mulants and other psychiatric medi-cations for preschoolers has increasedsubstantially.5 The US Food and DrugAdministration does not recommendthese medications in children younger

than 6 years because of limited in-vestigation of the agents’ efficacy andsafety in this population. A previousendorsement for mixed amphetaminesalts (MAS) no longer appears on theFood and Drug Administration Website.6

Few comprehensive reviews of inter-ventions for preschoolers with ADHDare available, and most have eitherfocused on parent interventions or onpsychostimulant use.7–9 Several werecompleted by authors involved in thedevelopment of the specific inter-ventions reviewed, causing a risk ofperceived bias. In contrast, Ghumanet al10 reviewed a range of inter-ventions for preschool children withADHD. To address the need for in-formation about medication use, theyincluded studies with a subset of chil-dren of preschool age. Based on gen-eral clinical consensus, they concludedthat parent behavior training (PBT)interventions should be tried beforemedication among preschoolers withADHD.10 Indeed, the Preschool ADHDTreatment Study (PATS), funded by theUS National Institute of Mental Healthspecifically to evaluate efficacy andsafety of methylphenidate in this agegroup, included PBT before randomi-zation as the first phase for all childrenrecruited.11

To date, no information is available ontheeffectivenessofPBTwhencomparedhead to head with methylphenidate astreatment of preschoolers with ADHDsymptoms. To address this informationgap, the current review critically ex-amined and compared effectivenessand adverse events of available inter-ventions in preschool children withclinically significant disruptive behav-ior, who are therefore at high risk forADHD.3 We sought to enlarge general-izability of the results by includingstudies of preschool children who metcriteria for clinically impairing symp-toms of disruptive behavior, including

ADHD symptoms, for the following rea-sons: (1) in general practice, aggressionand noncompliance are common con-cerns for parents and frequently rea-sons for clinical referral; (2) ADHD inpreschoolers is commonly identified inthe context of comorbid oppositionaland aggressive behaviors12; (3) accu-rate diagnosis of ADHD when disruptivebehavior is present is especially dif-ficult in preschool-aged children2; and(4) most preschoolers with opposi-tional defiant behavior are at high riskfor meeting criteria for ADHD by age 7.3

The key question that shaped the com-parative effectiveness review fol-lows: Among children younger than6 years with ADHD or disruptive be-havior disorder, what are the effec-tiveness and adverse event outcomesafter treatment?

METHOD

Search Strategy

The following databaseswere searchedfrom 1980 through November 24, 2011:Medline, Cochrane CENTRAL, Embase,PsycInfo, and ERIC (Education Resour-ces Information Center). Strategiesused combinations of controlled vo-cabulary (medical subject headings)and text words (eg, “Attention Deficitand Disruptive Behavior Disorders”/ orattention deficit disorder with hyper-activity/ or Conduct Disorder/ or mini-mal brain d?sfunction*.tw,sh). Fordetails see Appendix A.

Inclusion Criteria

Included articles were published inEnglish, investigated interventions forchildren younger than 6 years withclinically significant disruptive behav-ior identified by referral to treatment;reliable and valid screening measures;or a diagnosis of ADHD, oppositionaldefiantdisorder, orconductdisorderbyDiagnostic and Statistical Manual ofMental Disorders versions III, IIIR, andIV or International Classification of

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Diseases version 9 and 10 criteria.Study designs comparing interventionswith other conditions were included,grouped with their companion arti-cles. Most included studies were ran-domized controlled trials (RCTs).Interventions reviewed included phar-macological and nonpharmacologicalinterventions (eg, behavior training forparents, teacher, or child; psychosocialinterventions; combinations of theseitems). Alternative or complementaryinterventions (eg, diet, massage, bio-feedback) were excluded. All effec-tiveness outcomes or adverse eventoutcomes were examined.

Data Extraction

For the purposes of this systematicreview, trained data extractors usedstandardized forms developed inDistillerSR (Evidence Partners Inc, Ot-tawa, Ontario, Canada) and MicrosoftExcel for data management. Key studyelements extracted were reviewed bya second person to confirm inclusioncriteria. Disagreements were resolvedby consensus.

Evaluation of Individual Studies

Two independent raters assessed in-ternal validity of reports using the Ef-fective Public Health Practice ProjectQuality Assessment Tool for Quantita-tive Studies Risk of Bias.13 This tool waschosen because it evaluates the fullrange of comparative study designsthat met inclusion criteria, and hasbeen shown to have excellent inter-rater reliability on global grades ofstudy quality.14 Details regarding deri-vation of global study grade of “good,”“fair,” or “poor” are provided in Ap-pendix B. Disagreements were re-solved by a third rater.

Data Synthesis

For each category of intervention, trialswere examined to identify similarlydesigned studies with independent

samples for pooling results. Only thecategory of PBT interventions providedresults that could be synthesizedquantitatively, and meta-analytic tech-niques were performed according topublished guidelines.15 Estimates ofoverall effect and between-study het-erogeneity were obtained by using Re-view Manager software (RevMan 5.1;Nordic Cochrane Center, Copenhagen,Denmark). Effect estimates were de-rived for 2 outcome measures: parent-reported child disruptive behavior,including ADHD symptoms, as well asparent-reported parenting skills (com-petence) outcomes. See Appendix C fordetails of analyses, including calcula-tion of standardized mean difference(SMD) and evaluation of between-studyheterogeneity. Statistical stability wasevaluated by comparing the estimateincluding only those studies rated asgood with estimates including both fairand good studies.

To investigate the impact of PBT inter-ventions specifically on core ADHDsymptoms, the subset of studies in-vestigating change in hyperactivity, im-pulsivity, and inattentionwere identified.In the same manner as in the primaryanalyses, study outcomes were pooled,effect estimate derived, and between-study heterogeneity and statistical sta-bility evaluated. See Appendix C.

Where reports of intervention outcomescould not be pooled quantitatively, weprovide descriptive summaries.

Rating the Body of Evidence

The overall strength of evidence (SOE)for interventions to address disruptivebehavior, including symptoms of ADHD,in preschool children was assessedusing the Grading of RecommendationsAssessment, Development, and Evalua-tion guidelines.16,17 The following fac-tors were taken into consideration:internal validity of studies, study de-sign (experimental versus observa-tional), consistency of results across

studies, directness of evidence linkingintervention and outcome, and pre-cision of effect estimate. For each cat-egory of intervention, summary ratingsof “high,” “moderate,” “low,” and “in-sufficient” were assigned based on theAgency for Healthcare Research andQuality Effective Healthcare Programscale for rating evidence.17 A high rat-ing for SOE represents consistent evi-dence from good studies in whichfurther research is very unlikely tochange the conclusions; a moderaterating indicates that results supportthe interventions but further researchcould change the conclusions; a lowrating indicates there are few stud-ies available or existing studies areflawed; and an insufficient rating sug-gests that evidence is not available orthat studies offer conflicting results.Summary ratings were reachedthrough consensus among 3 authors(A.C., P.C., S.F.).

RESULTS

Figure 1 provides the flow diagram forsearch results. The final screeningidentified 55 reports describing pre-school interventions for children ,6years old with disruptive behavior, in-cluding ADHD. Of these, 34 describedPBT trials, 1 of these combined PBTwith a group for children,18 15 de-scribed psychostimulant trials, primar-ily immediate-release methylphenidate,and 6 described interventions combin-ing PBT and school- or day care–basedcomponents.

PBT Interventions for PreschoolChildren With Disruptive Behavior,Including ADHD

PBT interventions are designed to helpparents manage their child’s problembehaviors with more effective disciplinestrategies by using rewards and non-punitive consequences. An importantaspect of each is to promote a positiverelationship between parent and child.

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Each programalso includes educationalcomponents regarding childhood be-havior problems and common devel-opmental issues, and may includecoaching or consultation to supportparents’efforts. Primary outcomes areimproved child behavior and parentingskills.

Several standardized PBT interventionshave been developed to address dis-ruptive behavior in preschoolers inthe past 25 years, 4 of which figureprominently in the literature. Althougheach program has its own specific fea-tures, the Positive Parenting Program(Triple P),19–25 Incredible Years ParentingProgram (Incredible Years),18,26–29

Parent-Child Interaction Therapy,30–37

and the New Forest Parenting Program

(New Forest)38–41 all disseminate in-struction manuals to ensure in-tervention integrity and uniformityacross studies. In addition, each ofthese programs has published morethan 1 study evaluating the inter-vention for preschool children. Overtime, some programs have adaptedinterventions to address symptoms ofADHD.

The literature search identified 34reports of PBT interventions for dis-ruptive behavior, including ADHDsymptoms, in preschoolers.18–51 Ofthese, 32 met criteria for good or fairinternal validity18–22,24–49,51 (Tables 1and 2). Fourteen good or fair RCTswith independent samples wereidentified.19–22,28,30,32,33,36,38,41,43,45,49 Of

these, 13 reported baseline and post-intervention child behavior outcomes,with total n = 558.19–22,28,30,32,33,36,38,41,45,49

These were pooled for meta-analysisand resulted in a moderate effect sizeof SMD= –0.75 (95%confidence interval:–0.93 to –0.58) favoring intervention(Fig 2). Despite use of different outcomemeasures, heterogeneity among studieswas minimal (Q test, P = .65 and I2 =0.0%). For the parenting skills outcome,results of 14 good or fair studies werepooled19–22,28,30,32,34,37,38,41,43,45,49 (Fig 3).With a total n = 707, results showeda moderate effect size favoring the in-tervention and SMD = 0.55 (0.36–0.73)for parenting skills with low heteroge-neity (Q test, P = .18 and I2 = 25%). Toevaluate stability of results, we alsoexamined the pooled results of the 8good studies, n = 424.21,22,28,30,33,38,41,49

For child behavior, these 8 studiesresulted in a moderate effect size ofSMD = –0.68 (–0.88 to –0.47) withminimal heterogeneity (Q test, P = .92and I2 = 0%) (Fig 4). For parent skills,SMD = 0.49 (0.30–0.68) with minimalheterogeneity (Q test, P = .90 and I2 =0%)21,22,28,30,34,38,41,49 (Fig 5). Not sur-prisingly, the SMD from the goodstudies was somewhat smaller, andshowed less between-study heteroge-neity than that of the pooled results ofthe good and fair studies.

Five good and fair trials examined theeffect of PBT on 1 or more core symp-toms of ADHD, hyperactivity, impulsivity,or inattention.28,32,33,38,41 Three studiesrequired that the child have ADHD forenrollment,32,38,41 and 2 describedadjusting the intervention to addresssymptoms of ADHD.38,41 These 5 studies,total n = 279, were pooled for meta-analysis to examine the effect of PBTon ADHD symptoms and resulted ina moderate effect size of SMD = –0.77(–1.21 to –0.34) favoring intervention(Fig 6). There was amoderate degree ofheterogeneity observed (Q test, P = .04and I2= 60%). We examined results from

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1st Full-text screening assessed for eligibility (n = 1 347)

Full-text ar�cles excluded (n = 177)

Not eligible popula�on = 93 Not eligible treatment = 39 No eligible comparison = 38 Long term outcomes pre-1997

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FIGURE 1Flow diagram for search results.

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the pooled meta-analysis of the 3 goodstudies,28,38,41 with n = 213. Resultsshowed SMD = –0.62 (–1.01 to –0.23)favoring intervention, with minimalheterogeneity (Q test, P = .21 and I2 =36%) (Fig 7).

Additional support for effectiveness ofPBT interventions includes observa-tions of a “dose effect,” in whichgreater benefit is associated with in-creased number of sessions attendedby parents,26,52 and documentation thatbenefits are sustained over 6 months

comparedwith wait list control childrenwho show little improvement.28,38,47 At-trition rates for efficacy trials rangedfrom ,5%19,20,51 to 28%,22,24 with nodiscernible advantage to any specificPBT program. Additional factors influ-encing outcome were reported for theNew Forest program, with maternalADHD and delivery by nonspecializedhealth care nurses shown to interferewith effectiveness.39,40 No studies com-mented on the complexity of the child’sclinical presentation as a moderator of

efficacy, and no adverse events forchildren or parents were described.In summary, PBT interventions reducedisruptive behavior, including ADHDsymptoms, in preschool-aged children,and improve parenting skills. Benefitsare maintained after completion of thetreatment for at least 6 months frombaseline. In general, group and individualvariants of parenting interventionsappear to be similarly effective, asmeta-analyses of RCT outcomes showminimal heterogeneity. One primary

TABLE 1 Characteristics of Studies of PBT for Preschool-Aged Children With Disruptive Behavior, Including ADHD

Study Intervention Length ofInterventionPrimary/Follow-up

Characteristics of Intervention

Mode of Delivery Location of Delivery Adjunctive Components

Group Individual Self-directed

Home Community Clinic DirectInterventionWith Child

ParentMentalHealth

MaritalConflict

Bagner, 200730 PCIT 4 mo/0 ✓ ✓

Bor, 200222 Triple P 15 wk/1 y ✓ ✓ ✓ ✓

Bywater, 200929 IYPP 12 and18 mo fuConnell, 199720 SDBI pre-Triple P 10 wk/4 mo ✓ ✓

Cummings, 200842 SET-PC/IYPP 14 wk/1 y ✓ ✓ ✓ ✓

Cunningham, 199543 CBPT 8 wk/6 mo ✓ ✓ ✓ ✓

Dadds, 199225 CMT versus CMT +AST pre-Triple P

8 wk/6 mo ✓ ✓

Eyberg, 199536 PCIT 12 wk/0 ✓ ✓

Funderburk, 199835 PCIT 12 mo and 18 moHood, 200331 PCIT 3-y–6-y fuHutchings, 200728 IYPP 12 wk/6 mo ✓ ✓

Jones, 200727 IYPP 12 wk/6 mo ✓ ✓

Jones 200844 IYPP 1 y and 2 yLandy, 200645 HEAR 15 wk/0 ✓ ✓

Lavigne, 200826 IYPP 12 wk/1 y ✓ ✓ ✓

Markie-Dadds, 2006a21 Triple P 17 wk/6 mo ✓ ✓

Markie-Dadds, 2006b19 Triple P 12 wk/6 mo ✓ ✓

Matos, 200932 PCIT 12 wk/3.5 mo ✓ ✓

McGrath, 201151 StrongestFamilies

12 wk/12 mo ✓ ✓ ✓

Nixon, 200334 PCIT 12 wk/6 mo ✓ ✓ ✓ ✓

Nixon, 200133 PCIT 12 wk/6 mo ✓ ✓

Nixon, 200446 PCIT 1 y and 2 y fuPisterman, 198947 PT 12 wk/3 mo ✓ ✓

Pisterman, 1992a49 PT 12 wk/3 mo ✓ ✓

Pisterman, 1992b48 PT 12 wk/3 mo ✓ ✓

Sanders, 198523 Triple P 7 wk/3 mo ✓ ✓ ✓

Sanders, 200724 Triple P 1 y and 3 y fuShuhmann, 199837 PCIT 12 wk/4 mo ✓ ✓

Sonuga-Barke, 200138 NFPP 2 mo/15 wk ✓ ✓

Sonuga-Barke, 200240 NFPP 2 mo/15 wk ✓ ✓

Sonuga-Barke, 200439 NFPP 8 wk/5 wk ✓ ✓

Thompson, 200941 NFPP 8 wk/9 wk ✓ ✓ ✓

Webster-Stratton, 201118 IYPP + child group 20 wk/0 ✓ ✓ ✓

Weeks, 199750 NFPP 8 wk/0 ✓ ✓

AST, Ally Support Training; CBPT, Community-Based Parent Training; CMT, Child Management Training; fu, follow-up; HEAR, Helping Encourage Affect Regulation; IYPP, Incredible Years ParentingProgram; MPH, Methylphenidate; NFPP, New Forest Parenting Program; PT, parent training; PCIT, Parent Child Interaction Therapy; SDBI, self-directed behavioral intervention; SET-PC, SupportiveExpressive Therapy–Parent Child; Triple P, positive parenting program; WLC, wait list control.


TABLE 2 Summary of Good and Fair Studies of PBT for Preschool-Aged Children with Disruptive Behavior, Including ADHD

Study Quality n, Mean Age,% Male, Attrition

InterventionsCompared

Results

Child Behavior Parent Competence

Bagner, 200730 Good n = 30Age: 54 moMale: 77%27% attrition in trial

PCIT versus WLC Developmentally delayed childrenshowed improved compliancewith Tx

ECBI-I P , .002

Improved parenting skills observedwith Tx P = .006

Bor, 200222 Good n = 87Age: 41 mo

Triple P standard versusEBFI versus WLC

Improved behavior with both TxECBI-I P , .01

Improved parenting competencewith both Tx

Male: 68% Improvements maintained at 1 y PSOC P , .00128% attrition in trial Improvements maintained at 1 y

Bywater, 200929 SeeHutchings, 200728

Good n = 153Age: 46 mo

IYPP 12 mo and 18 mofollow-up

Improvements maintained at12 mo and 18 mo

Improvements maintained at 12 moand 18 mo

Male: 58%13% attrition at 6 mo

Connell, 199720 Fair n = 24Age: 49 mo

Triple P SD versus WLC Improved behavior with Triple P SDwith telephone contact

Improved parenting competencePSOC P , .001

Male: 43% ECBI-I P , .001 Improvements maintained at 4 mo4% attrition in trial,40% at 4 mo

Improvements maintained at 4 mo

Cummings, 200842 Good n = 54Age: 50 mo

IYPP versus SET-PC Improved child behaviors withboth Tx over time

Improved parenting skills observedwith both Tx over time.

Male: 61% Improvement maintained at 1 y Improvement maintained at 1 y25% attrition in trial

Cunningham, 199543 Good n = 150Age: 54 moMale: 51%

CBPT versus clinic/individual versus WLC

Improved child behavior in homesituations with CBPT . clinicand WLC at 6 mo

Improved parenting competence inclinic/individuals . CBPT andcontrol

24% attrition at 6 mo HSQ P = .05 Pre to post P , .05Improved child behavior in all 3conditions from pre to 6 mo onCBCL

Improved parenting in all 3conditions from pre to 6 mo onPSOC

Dadds, 199225 Fair n = 22Age: 55 moMale: 68%

CMT versus CMT withsupport person (ally)(pre-Triple P)

Improved child behavior with bothTx from pre to post

Improvement maintained at 6 mo

Improved parenting skills observedwith both Tx from pre to post

Improvement maintained at 6 moAttrition NR

Eyberg, 199536 Primarystudy related toSchuhmann, 199837

Hood, 200331

Fair n = 50Age: 64 moMale: 80%28% attrition in trial

PCIT versus WLC Improved behavior with TxECBI-I P , 0. 01

Improved parent locus of controlwith Tx

PLOC P , .02

Funderburk, 199835 Good n = 84Age: 5 4moMale: 100%

PCIT versus classroomcomparisongroupsat12 mo and 18 mo

Improved classroom behaviormaintained at 12–24 mo versusclassroom comparison.

NR

25% attrition at 18 mo Blind observer ratings showed (1)improved compliance and on taskbehavior maintained at 12 mo, (2)improved compliance maintainedat 18 mo

Hood, 200331 Fair n = 28Age: 60 mo

PCIT 3–6 y follow-up Improved behavior maintained at3 to 6 y

Improved PLOC maintained at3 to 6 y

Male: 70%44% attrition at 3-6 y

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TABLE 2 Continued



Results


Hutchings, 200728

Primary study forJones, 2007,27 Bywater,2009,29 Jones, 200844

Good n = 153Age: 46 moMale: 58%13% attrition in trial

IYPP versus WLC at 6 mo Improved behavior with Tx versusWLC at 6 mo

ECBI-I P , .001Conners P , .001ITT analysis

Improved parenting skills observed(blind) with Tx versus WLC at 6 mo

P = .002

Jones, 200727SeeHutchings, 200728Seealso Bywater, 200929;Jones, 200844

Good n = 79Age: 46 moMale: 68%10% attrition in trial

IYPP versus WLC at 6 mo Controlling for changes in disruptivebehavior, ADHD behaviors alsoimproved

Connors P , .013

NR

ITT analysis

Jones, 200844 SeeBywater, 200929: Seealso Hutchings, 200728;Jones, 200727

Good n = 50Age: 46 moMale: 64%12% attrition at 1 y and 2 y

IYPP 1 y and 2 y follow-up Improvement in ADHD behaviorsmaintained at 1 y and 2 y

NR

Landy, 200645 Fair n = 35Age: 54 mo

HEAR versus WLC Improved behavior with TxECBI-I P , .01

Improved parent skills andconfidence with Tx

Male: 80%23% attrition in trial

Lavigne, 200826 Good n = 117Age: 54 moMale: 53%15% attrition at 1 y

IYPP (RN versus PhD)versus MIT

Improved behavior with all 3 Tx, after12 wk, and continuedimprovement at 1 y, including inthe MIT (book and pediatric care)

NR

Greater improvement when parentsattended 7 ormore sessions: doseeffect versus MIT

Improvement maintained orincreased at 1 y

Markie-Dadds, 2006a21 Fair n = 63Age: 43 mo

Triple P SD versus WLC Improved behavior with Triple-P SD,no telephone contact

Improved parenting competencewith Tx

Male: 63% ECBI-I P , .01 PSOC-Efficacy P , .0525% attrition in trial Improvement maintained at 6 mo Improvement notmaintained at 6mo43% attrition at 6 mo

Markie-Dadds, 2006b19 Good n = 41Age: 47 mo

Triple P SD versus ESDversus WLC

Improved behavior with both Txversus WLC

Improved parenting competence inESD versus WLC

Male: 76% ECBI-I P , .001 PSOC-Efficacy P , .0013% attrition in trial; 7%at 6 mo

Disruptive behavior improved inESD .SD

Improvement maintained at 6 mo

Improvements maintained andadditional improvement in SD at6 mo

Matos, 200932 Fair n = 32 PCIT versus WLC Improved behavior with Tx Improved parenting skillsAge: NR ECBI-I P , .0001 PPI P , .0001Male: NR BASC hyperactivity. P , .0001 Improvement maintained at 7 mo9% attrition at 7 mo Improvement maintained at 7 mo

McGrath, 201151 Good n = 80Age: 59 moMale:78%

Strongest Familiesversus TAU

Improved behavior with Tx, shown byno longer meeting ODD diagnosis(blind assessor)

NR

Attrition: , 5% P = .01Improvement maintained at 6 mo

versus TAUNot maintained at 12mo versus TAUITT analysis


TABLE 2 Continued



Results


Nixon, 200133 Fair n = 34 PCIT versus WLC Improved behavior with Tx; NRAge: 47 mo ECBI-I P , .01Male: 73% ADHD symptoms P , .05Attrition NR Improvement maintained at 6 mo

Nixon, 200446 Related toNixon, 200334

Fair n = 37Age: 47 moMale: 70%

PCIT versus ABB PCIT 1 yand 2 y follow-up

Improved behavior with bothinterventions maintained at 1-yand 2-y follow-up

Improved parenting skills observedwith both TX, maintained at 1-yfollow-up

5% attrition at 2 y

Nixon, 200334 Primarystudy for Nixon, 2001,33

Nixon, 200446

Good n = 54Age: 47 moMale: 70%

PCIT versus ABB PCITversus WLC

Improved behavior with both Txversus WLC

ECBI-I P , .001

Improved parenting competencewith both Tx versus WLC

PSOC P , .0513% attrition in trial Improvements maintained at 6 mo Improved parenting skills observed

(blind) with PCIT versus WLCP , .01

Improvements maintained at 6 mo

Pisterman, 198947 Good n = 50 PT versus WLC Improved child compliance with Tx Improved parenting skills with TxAge: 50 mo Observed task P , .01 Observed task P , .01Male: 80%8% attrition in trial

Improvements maintained at 6 moversus WLC


Pisterman, 1992a49 Fair n = 57 PT versus WLC Improved child compliance with Tx Improved parenting skills with TxAge: 50 mo Observed task P , .01 Observed task P , .01Male: 91%21% attrition in trial



No improvement on attention task

Pisterman, 1992b48 Seealso Pisterman 1989,47

and 1992a49

Good n = 91Age: 50 moMale: 86%15% attrition at 3 mo

PT versus WLC NR Improved parenting competencewith Tx

PSOC P , .001Improvements maintained to 6 mo

versus WLC

Sanders, 200724 SeeMarkie-Dadds 2006a21

and 2006b,19 Bor,200222

Fair n = 139Age: 85 moMale: 68%18% attrition from trial;

48% attrition at 1 y and54% at 3 y

Triple P standard versusSD versus EBFI 1-y and3-y follow-up

Child behavior improved over timefor all conditions at 1 y andmaintained at 3 y

Improved parenting at 1- and 3-yfollow-up

Schuhmann, 199837

Related to Eyberg,199536 and Hood,200331

Fair n = 64Age: 59 moMale: 81%35% attrition at 1 y

in trial

PCIT versus WLC Improved behavior with TxECBI-I P , .01ECBI-P P , .01Improvements maintained at 8mo

Improved parenting skills, stress;increased locus of control with Tx

PLOC P , .01Improvements maintained at 8 mo

Sonuga-Barke, 200138 Good n = 78Age: 36 mo

PBT (preNFPP) versusPCS versus WLC

Improved ADHD behavior observedwith PBT

Improved Maternal index with PBTversus PCS P = .005

Male: 62% versus PCS P = .002 versus WLC P = .00019% attrition in trial versus WLC P = .0001

Improvements maintained at 23 wkversus WLC

Improvements maintained at 23 wkversus WLC

ITT analysis

Sonuga-Barke, 200240 Seealso Sonuga-Barke,200138

Good n = 89Age: 36 moMale: 63%

PBT (preNFPP) versusWLC

Maternal ADHD interfered withimprovements in behavior

REVIEW ARTICLE


barrier to optimal effectiveness is thatsome parents do not complete therecommended number of sessions.

Efficacy and Safety ofPsychostimulant Interventions forPreschool Children With ADHD

Fifteen articles, representing 10 stud-ies,53–67 examined the efficacy ofpsychostimulants, primarily immediate-release methylphenidate, prescribed2 or 3 times daily in preschool childrenwith documented ADHD. Eleven articlesrepresenting 6 studies were rated asgood or fair in quality53,56–59,61–66

(Table 3). The largest randomized clin-ical trial, the Preschool ADHD Treat-ment Study,61–65 with n = 165 in thecrossover titration phase, and n = 114in the parallel RCT phase, receiveda good rating for internal validity and isdescribed later in this article. Theother 4 studies included samplesranging in size from n = 11 to n = 44,primarily boys from families withmiddle socioeconomic status withADHD combined or hyperactive/impulsivesubtypes.53,56,58,66 Three of these trialswere within-subject crossover designs

lasting 4 to 5 weeks.56,58,66 Two studiesexamined children with ADHD and de-velopmental disabilities or pervasivedevelopmental disorders.56,58 Almost allstudies compared immediate-releasemethylphenidate with placebo.53,56,58,66

One study59 compared the most effec-tive and well-tolerated dose of eithermethylphenidate or MAS to placebo, al-though only 6 children received MAS. Allstudies noted improved ADHD behaviors(ie, inattention, hyperactivity, impulsivity)on active treatment. Those studies ex-amining adverse events noted thatbehaviors attributed to side effects werealso present in subjects on placebo.56,57,59

Adverse events were more common andof greater intensity at high than lowdoses.57 Poorappetite, socialwithdrawal,lack of alertness, stomach ache, irrita-bility, and rebound were increased onmedication relative to placebo.56,59

PATS

The multisite National Institute of Men-tal Health–funded PATS61–65 offers high-quality evidence about efficacy, safe-ty, and effectiveness of immediate-release methylphenidate, 3 times daily,

for preschool children 3 to 5 years ofage.

The PATS Study61–65 addressed a num-ber of important methodological lim-itations, and documented efficacy ofmethylphenidate for symptoms ofADHD in preschoolers. Before the trial,parents were offered a series of 10PBT sessions. Thirteen percent ofpreschool children with ADHD symp-toms benefited sufficiently to no lon-ger meet clinical threshold or parentswere satisfied with degree of im-provement. Another 12% of parentspreferred no further intervention andtherefore did not start medication.Documentation about how many fam-ilies completed the PBT sessions is notprovided.

There were 4 consecutive methyl-phenidate trial phases in total: anopen-label safety lead-in phase, RCTwithin-subject titration phase, best-dose RCT parallel group phase, anda 10-month open-label maintenancephase. Methylphenidate improvedcore parent-rated and teacher-ratedADHD symptoms during the within-subject crossover titration phase

TABLE 2 Continued



Results


Sonuga-Barke, 200439 Seealso Sonuga-Barke,200138

Good n = 89Age: 36 moMale: NR

PBTdeliveredbyprimarycare versus WLC

PBT delivered by nonspecialty carenursesdid not improve child ADHDbehavior

Maternal well-being diminished inboth groups

16% attrition in trial ITT analysis

Thompson, 200941 Good n = 41 NFPP versus TAU Improved ADHD behavior with Tx ImprovedparentskillsobservedwithTxAge: 52 mo PACS P , .01 P = .03Male: 100%5% attrition in trial;

Improvements maintained to 17 wkversus TAU

Improvement not well maintainedat 17 wk

27% attrition at 17 wk

Webster-Stratton, 201118 Good n = 99Age:64 moMale: 75%5% attrition in trial

IYPP + Child groupversus WLC

Improved behavior with TxECBI-I P , .001

Improved parent skills observedwith Tx

P , .001

ABB, abbreviated PCIT delivery; BASC, Behavior Assessment Scale for Children; CBCL-At, child behavior checklist-attention; CBCL-E, child behavior checklist-externalizing; CBPT, community-basedparenting program; CI, confidence interval; CMT, Child Management Training; EBFI, enhanced behavioral family intervention; ECBI, Eyberg Child Behavior Inventory; ECBI-I, Eyberg Child BehaviorInventory–Intensity; ECBI-P, Eyberg Child Behavior Inventory–Problem; ESD, enhanced self-directed Triple P; ESL, English as a second language; HEAR, Helping Encourage Affect Regulation; HSQ,Home Situations Questionnaire; ITT, intention to treat; IYPP, Incredible Years Parenting Program; MIT, minimal intervention therapy; n , sample size; NFPP, New Forest Parenting Program; NR, notreported; NS, not significant; ODD, oppositional defiant disorder; PACS, Parent Account of Child Symptoms; PCIT, Parent-Child Interaction Therapy; PCS, parent counseling and support; PS,parent stress; PS-T, parenting style, total; PSI, parent stress index; PLOC, parental locus of control; PSOC, parenting sense of competence; PPI, Parenting Practices Inventory; PT, parent training;SD, self-directed Triple P; SET-PC, Supportive Expressive Therapy–Parent Child; TAU, treatment as usual; Triple P, positive parenting program; Tx, treatment; WLC, wait list control.


with a mean optimal single dose of0.7 6 0.4 mg/kg, and with a meanoptimal total daily dose of 14.2 6 8.1mg/kg per day.65 The RCT parallelgroup phase documented that best-dose methylphenidate resulted ina small positive effect for teacher-but not parent-rated ADHD symptoms

and social competence, no improve-ment in parental stress, and moder-ate worsening of parent-rated childmood. In contrast, clinicians ratedchildren as improved with moderateto large effect size.61,65 Preschoolchildren with 3 or more comorbidconditions at baseline (15% of sample)

were least likely to benefit from meth-ylphenidate, with children having only1 or no comorbid conditions showinggreatest benefit.62 Preschool childrenexperienced dose-related adverseevents leading to discontinuationat rates higher than reported forolder children,64 and showed decline

FIGURE 2Effect of PBT on disruptive behavior in preschool-aged children (good and fair studies). *Includes RCTs rated as good and fair quality (assumes correlationbetween post- and pre-score of 0.3). Means are post/pre differences; SMD reflects difference of these differences.

FIGURE 3Effect of PBTon parenting skills (good and fair studies). *Includes RCTs rated as good and fair quality (assumes correlation between post- and pre-score of 0.3).Means are post/pre differences; SMD reflects difference of these differences.

REVIEW ARTICLE


in growth rates over 12 months ofthe trial and open-label extension.63

Approximately half of participantswho tried medication in the open-label lead-in phase completed the10-month maintenance phase; 14%

discontinued the trial because ofadverse effects.64,65 Parents’ con-cerns about their child’s ability totolerate medication, as well as theirtreatment preferences, were bothlikely factors contributing to the

low rate of participants enteringthe long-term extension trial. Ac-knowledging these concerns shouldbe an important part of providingoptimum care for young children withADHD.

FIGURE 4Effect of PBT on disruptive behavior in preschool-aged children (good studies). *Includes RCTs rated as good quality (assumes correlation between post- andpre-score of 0.3). Means are post/pre differences; SMD reflects difference of these differences.

Study or SubgroupBagner 2007Bor 2002Hutchings 2007Markie-Dadds 2006aNixon 2003Pisterman 1992Sonuga-Barke 2001Thompson 2009

Total (95% CI)Heterogeneity: Tau² = 0.00; Chi² = 2.80, df = 7 (P = .90); I² = 0%Test for overall effect: Z = 5.08 (P < .00001)

Mean10

9.6516.72.936.8213.12.920.87

SD10.2216.8727.474.539.4426.35.9

2.13

Total1021

1042117463017

266

Mean4.69

–1.123.1

0.320.59

1.3–0.720.72

SD8.6714.3

27.767.849.15

34.183.521.97

Total1227492217452013

205

Weight4.8%

10.3%30.0%

9.7%7.4%

20.6%10.4%

6.8%

100.0%

0.54 [–0.31, 1.40]0.68 [0.10, 1.27]0.49 [0.15, 0.84]

0.40 [–0.21, 1.00]0.65 [–0.04, 1.35]0.38 [–0.03, 0.80]0.70 [0.12, 1.29]

0.07 [–0.65, 0.79]

0.49 [0.30, 0.68]

Experimental Control SMDIV, Random, 95% CI

–2

SMDIV, Random, 95% CI

–1 0 1 2Favors Control Favors Experimental

FIGURE 5Effect of PBTon parenting skills (good studies). *Includes RCTs rated as good quality (assumes correlation between post- and pre-score of 0.3). Means are post/pre differences; SMD reflects difference of these differences.

FIGURE 6Effect of PBT on ADHD symptoms in preschool-aged children (good and fair studies). *Includes RCTs rated as good and fair quality (assumes correlationbetween post- and pre-score of 0.3). Means are post/pre differences; SMD reflects difference of these differences.


Effectiveness of Combinations ofParent Behavior Training andSchool- or Day Care–BasedInterventions for PreschoolChildren With Disruptive Behavior,Including ADHD

Six articles representing 5 studies ex-amining multiple-component psycho-social and/or behavioral interventionsfor disruptive behavior disorder inpreschool children met criteria forreview.52,68–72 These studies did not in-clude pharmacology interventions, butexamined combinations of PBT andschool- or day care–based interven-tions. Of these, 4 met quality criteria forgood,52,68,69,72 and 2 met criteria for fairinternal validity.70,71 Two studies exam-ined intervention effects on ADHD symp-toms and associated difficulties68,69

(Table 4). The study designs, sampleselection, interventions, and outcomemeasures vary widely, precludingmeta-analysis. Two of 5 studiesrecruited families from low socioeco-nomic communities.52,72 Some of thesefamilies did not attend group PBTsessions despite convenient times,and babysitting and transportationassistance.72 Parental attendance at 5or more sessions was associated withgreater improvement in child behav-ior.52 Only 1 study demonstrated thatchildren improved more when theyreceived both PBT- and classroom-based interventions.52 In contrast, 2trials recruiting children from a moreadvantaged community did not dem-onstrate added benefit from an in-tensive intervention compared with

psychoeducation.68,69 These trials of-fer conflicting results and thereforeprovide too little evidence to drawconclusions about combinations ofhome and school interventions.

SOE

Ratings for SOE were assigned to thebody of evidence for each of the 3identified intervention categories fordisruptive behavior, including ADHD, inpreschoolers (Table 5). The evidencefor PBT was rated high for the con-sistency of results with 8 good efficacytrials, supported by evidence of doseeffect and continued benefit 6 monthsafter baseline. Methylphenidate usewas given a low rating for SOE; thereis only 1 good trial (PATS study64,65)with findings supported by 3 small,within-subject trials of lesser qual-ity.56,58,66 The evidence for combinedhome and school behavioral inter-ventions was insufficient, as inter-ventions were diverse and resultscontradictory.

DISCUSSION

Our systematic literature review re-vealed 3 primary categories of in-tervention for disruptive behavior,including ADHD, which have beenevaluated in preschool-aged children:(1) PBT; (2) psychostimulant medica-tion, specifically immediate-releasemethylphenidate; and (3) combina-tions of PBT and teacher or classroominterventions. The first 2 categoriesrepresent the most commonly rec-

ommended treatments, frequently sim-plified as a choice between parent skillstraining ormedication. PBT is evaluatedusing a between-group design, andmethylphenidate is evaluated usinga within-subject design, making directcomparisons of effect size difficult tointerpret. Therefore, we used theGrading of Recommendation, Assess-ment, Development, and Evaluationapproach to rate SOE for effectiveness,which provides a global comparison ofinterventions by using clinically rele-vant evidence from the entire body ofliterature.17 Both PBT and methylphe-nidate were evaluated by experimentalstudies, and both show dose respon-siveness; 8 high-quality studies evalu-ated PBT but only 1 high-quality studyevaluated methylphenidate (Table 5).Overall, we judged PBT to show highSOE for improving child disruptivebehavior, including ADHD, in pre-schoolers; additional reports are veryunlikely to change the conclusion thatthe intervention works. Methylpheni-date has low SOE for improving childdisruptive behavior, including ADHD,because of the small number of qualitystudies available. The third categoryof multiple-component interventionsidentified diverse home and schoolinterventions, with conflicting results;therefore SOE was insufficient. Con-sidering evidence available, the bestfirst-choice treatment is PBT. In addi-tion, benefits of PBT continue after theintervention is completed, whereasmethylphenidate is associated withadverse effects.

FIGURE 7Effect of PBTon ADHD symptoms in preschool-aged children (good studies). *Includes RCTs rated as good quality (assumes correlation between post- and pre-score of 0.3). Means are post/pre differences; SMD reflects difference of these differences.

REVIEW ARTICLE


TABLE 3 Summary of Good and Fair Studies of Psychostimulant Interventions for Preschool-Aged Children With ADHD

Study Study Design,Quality Rating

n, Mean Age, %Male, Length ofStudy, Attrition

Interventions Compared Results Comments, Duration ofIntervention or Follow-up

MPH MAS PT Placebo Effectiveness Safety

Abikoff 200761

(PATS)RCTGood

n = 114Age: 4.4 yMale: 80%4 wk32% attrition

✓ ✓ Functional outcomes onMPH varied byinformant andmeasure, ITT LOCFanalysis:

One subject dropped outfor MPH related AE,most attrition due toAEs occurred intitration phase

High attrition from RCTdue to behavioraldeterioration (seeGreenhill 2006)66

PR and TR SWAN symptomscores showed noimprovement

Parent stress noimprovement

CGI-S improvedPR depression worsenedTR social competence

improvedGhuman 200762

(PATS)Crossover

titrationGood

n = 165 Age: 4.7 yMale: 74%5 wk11% attrition

✓ ✓ High ($3) comorbiditysubgroup showed noimprovement with MPHcompared withsignificant response inModerate, Low or Nocomorbiditysubgroups versusplacebo

NR Children in highcomorbidity subgrouphad more familyadversity than othercomorbidity subgroups(see also Greenhill2006)66

Greenhill 200665

(PATS)Crossover-

titration; &RCTparallel

Good

Crossover:n = 165Age: 4.7 yMale: 74%5 wk11% attritionRCT: n = 1144 wk32% attrition

✓ ✓ Crossover titration phase;ADHD symptoms

decreased on MPH at2.5 mg, 5.0 mg, and 7.5mg, with trend at 1.25mg TID versus placebo

RCT parallel phase; ADHDsymptoms decreasedon best dose versusplacebo, ITT LOCFanalysis

AE: Emotionality orirritability, appetiteloss, sleep, stomachache, socialwithdrawal, lethargy;Less commontachycardia, high bloodpressure; possibleseizure. Decreased wtvelocity (see Swanson200664)

Multiphase studyTitration trial effect size

(0.4–0.8) smaller thanfor school-agedchildren

Of those who discontinuedthe RCT due todeterioration inbehavior, 74% were onplacebo and 15% onmethylphenidate

Swanson 200663

(PATS)Extension of

RCTGood

n = 140Age: 4.4 yMale: 74%15 mo

✓ ✓ Evaluation of growth ratesfor those whocompleted 1 year ofMPH use and thosewhodid not

ADHD children started outlargerandheavier thannorms, and whilegrowth slowed on MPHregimen, they still werelargerandheavier thannorm at end of 1 y

10-momaintenancephasefollowing screeningphase, PBT, open-labellead-in, titration andRCT, approximately 15mo total

Wigal 200664

(PATS)RCTGood

n = 183Age: 4.8 yMale: 74%14 mo

✓ ✓ IncreasedADHDbehaviorswith MPH withdrawalsupports drug efficacy

30% of parentsspontaneously reportmoderate tosevereAEs,including emotionaloutbursts, troublefalling asleep, repetitivebehavior/thoughts,decreased appetite,irritability

1 wk open-label lead-in,5-wk RCT, 5-wk parallelphase, 10-mo open-label maintenance;attrition occurred witheach phase

11%discontinued due to AE

AEs increased withincreased dose


Until now, therehas been little guidancefor clinicians and families about whichtreatment to use first for preschoolerswith disruptive behavior, includingADHD. Considerations in addition toefficacy are important and decisionsmay be based on parent and practi-tioner preferences and on servicesavailable. Parents sometimes prefer touse nonpharmacological options first,

often citing concerns about safety andadverse effects.73 Indeed, preschool-aged children are susceptible to ad-verse effects of methylphenidate, withhigh rates of somatic concerns, irrita-bility and moodiness, and decrementsin growth,63–65 whereas adverse effectsare not reported for PBT. The PATSstudy demonstrated that children withmore complicated clinical pictures,

those with 3 or more comorbid con-ditions, worsened while on methyl-phenidate, whereas those with no ora single comorbid condition showedthe best response.62 Other studiessupport these observations, as pre-schoolers with developmental delaysmay respond to methylphenidate withincreased adverse effects.58 Becauseconcurrent developmental issues are

TABLE 3 Continued

Study Study Design,Quality Rating

n, Mean Age, %Male, Length ofStudy, Attrition

Interventions Compared Results Comments, Duration ofIntervention or Follow-up

MPH MAS PT Placebo Effectiveness Safety

Firestone, 199866

Samepopulation asMusten, 199757

CrossoverFair

n = 44Age: 4.8 yMale: 87%1 mo27% attrition

✓ ✓ MPH has positive effect ontemperament andnegative effect onsomatic complaintsand sociability athigher dose (P, .05 toP , .001)

Higher dosage ofstimulant medicationrelated to intensifiedfrequency andmagnitude of AE

Younger children maydisplay differentbehaviors than school-aged children while onMPH; behaviors mayhave been associatedwith the conditionrather than adverseevents

Ghuman, 200958 CrossoverFair

n = 14Age: 4.8 yMale: 93%5 wk18% attrition

✓ ✓ Improved behaviorreported by parentsand observed in clinic

Buccal-lingualmovementssignificantly increasedin Tx group; 50%showed mild tomoderate adverseevents

Developmentally delayedchildren with ADHDresponse to MPH moresubtle and variablethan among older and/or typically developingchildren

Handen, 199956 CrossoverFair

n = 11 ✓ ✓ Significant improvementon TR of hyperactivityand inattention as wellas activity levels andcompliance

Nearly half the childrenexperienced significantAE: withdrawal, crying,irritability

Developmentally delayedchildren with ADHDrespond to MPH,however may be moresusceptible to adversedrug side effects

Age: range 4.0 to5.1 y

Male: 82%5 wkAttrition NR

Heriot, 200753 RCTFair


✓ ✓ ✓ Most clinically significantresults in MPH + PTwhere 4/4 improved in2 or more domains. InPTonly and inMPH only,3/4improvedin1ormoredomains. In placeboand parent support 1/4improved in 1 domain

AE not reported MPH prescribed at 0.3mg /kg twice daily

Musten, 199757

Samepopulation asFirestone,199866

CrossoverFair


✓ ✓ Dosage effects notuniformly evident;positive effects oncognitive measures

Increased AE andincreased severity withhigher doses

MPH improves functioningof preschool childrensimilar to school-agedchildren; no evidencethat ODD wascontraindication

Short, 200459 CohortFair


✓ ✓ ✓ Improvement in behaviorwith either MPH orMAS(n = 6)

Titrated to best dose,there were minimaldifferences betweennumber or severity ofAE on activemedicationor placebo

Comparing best dose andplacebo. Best dose ofeither MPH twice dailyor MAS once dailyidentified bya preliminary trial

PATS studies listed first; ADHD, attention-deficit/hyperactivity disorder; AE, adverse events; CGI-S, Clinical Global Impressions–Severity; H, Hyperactivity; ITT LOCF, intent to treat last observationcarried forward; MAS, mixed amphetamine salts; MPH, methylphenidate; NR, not reported; ODD, oppositional defiant disorder; PATS Preschool ADHD Treatment Study; PR, parent rating; PT,parent training; SWAN, Strengths and Weaknesses of ADHD-symptoms and Normal Behaviors; TID, three times daily doses; TR, teacher rating; Tx, treatment.

REVIEW ARTICLE


TABLE4

Summaryof

Good

andFairStudiesof

CombinedHomeandSchool/Day

Care

Interventions

forPreschool-AgedChildrenwith

DisruptiveBehavior,Including

ADHD

Study

StudyDesign

Quality

Rating

Diagnosis

n,MeanAge,%

Males,SES

Interventions

Compared

Intervention

Duration,

Follow-up

Length,

Attrition

Results:Effectiveness

Comments,Other

Details

PTBehavioral

Teacher

Consult

Classroom

CC/

Parent

Edu

None

Barkley,2000

71

Follow-up

Shelton,2000

70

RCT

Fair

DBD

n=158

Age:4.8y

Male:40%

Lowtomiddle

SES

✓✓

✓Intervention

10wk

Attrition

NR

Improvem

entinDB

Dwith

TxCBCL-AtP

=.008

CBCL-AP=.002

Noimprovem

entinacadem

icskills

Pragmaticissues

interfered

with

random

izationto

somedegree

Hanisch,2010

52RCT

Good

Atrisk

for

DBD

n=155

Age:4.2y

Male:73%

LowSES

✓✓

✓Intervention

10wk

0%attrition

Parent

andteacherreportsof

Improved

DBwith

TxITTanalysisP,

.001

Dose

response

forPBT,with

attendance

at5or

moresessions

show

inggreaterbenefit

Kern,20076

9Prospective

cohort

Good

ADHD

n=135

Age:4y

Male:78.5%

Mixed population

SES

✓✓

✓Intervention

12mo

Follow-up

12mo

11%attrition

Improved

behavior

(ADH

D&

aggression)andsocialand

pre-academ

icskillsinboth

conditions

ITTanalysis

Approximatelyhalfofintervention

participantsreceived/acceptedall

3partsofthemulticom

ponent

intervention

McGoey,2005

68RCT

Good

ADHD

n=57

Age:4.0y

Male:85.9%

Primarilymiddle

class

✓✓

✓Intervention

Mean17

wk

0%attrition

Effectsofearlyinterventionwere

smalltomoderateandnot

consistentlyinexpected

direction.

Child

complianceoutcom

essimilarin

both

groups

Shelton,2000

70

Follow-upto

Barkley,2000

71

Follow-upto

RCTFair

DBD

n=158

Age:4.8y

Male:66.5%

✓✓

Intervention

10wk

(Barkley)

Follow-up

24mo

Attrition

NR

Despite

ongoingsignsofrisk

inDB

children,significant

improvem

ent

inallgroupsover

time

ITTanalysis,nosignificant

difference

betweenclassroomtreatedand

untreatedgroups

Nodifferences

betweenclassroom

treatedanduntreatedDB

groups.

Nodifferenceinpercentage

ofchildrenusingavailable

treatm

entsacross

thefollow-up

period.

Results

suggestthatearly

interventionclassroomforDB

childrenmay

notproduce

enduring

effectsonce

treatm

entis

withdraw

n.

Williford,20087

2Prospective

cohort

Good

Atrisk

for

ADHD

/OD

D

n=96

Age:4.5y

Male:70%

Predom

inantly

lower

SES

✓✓

✓Intervention

4mo(IYPP)

Follow-up

12mo

37%attrition

Interventiondecreasedchild

DBDin

theclassroom

Teachers

inconsultm

odeland

parentsinPBTmodelreport

improved

behavior

ADHD

,attention-deficit/hyperactivity

disorder;CBCL-A,ChildBehavior

Checklist–Aggression;CBCL-At,Child

Behavior

Checklist–Attention;CC/ParentEdu

community

care

orparenteducation;DB

,disruptivebehavior;DBD

,disruptivebehavior

disorder;ITT,

intentiontotreat;IYPP,IncredibleYearsParentingProgram;M

CI,m

ulticom

ponent

intervention;OD

D,oppositionaldefiantdisorder;PBT,parentb

ehaviortraining;SES,socioeconom

icstatus;Tx,treatm

ent.


common among preschoolers withbehavior problems, these observationsare important to consider whenchoosing interventions.

Although adverse events are notreported for PBT, important barriers toeffective intervention exist, and includelack of access to evidence-based pro-grams. In addition, a significant pro-portion of parents (up to 28%) fail tocomplete the intervention, whether of-fered as group sessions or individ-ually.22,36 Several studies examined PBToffered in the family home.19,22,38,41 Al-though this may overcome parent re-luctance to participate in groups anddifficulties accessing transportationor child care, it is a time- and resource-intensive method of delivering clin-ical service. Other less costly andaccessible methods of delivery arecommunity-based groups, and self-directed learning programs.19,21,43 Noveladditions to dissemination methods aretelephone-based or Web-based PBT forparents.51

Methodological limitations in the trialsevaluating PBT include small samplesizes, use of wait-list controls, and re-liance on parent report for child be-havior outcomes, with little informationabout child behavior in classroom orday care settings; however, 3 studiesdocumented change in parenting skills

through blind observations.25,28,34 Onereport described child behavior ob-served in the classroom setting.35 Al-though most analyses included onlythose participants who completed theinterventions, studies using intention-to-treat analyses support the conclu-sion that PBT is effective.28,38,39,51,52

Effective interventions exist forpreschool-aged children who come toclinical attention for disruptive be-havior disorders. As recommended bythe recent AAP guidelines, preschoolyoungsters with disruptive behaviorshould be referred for a thoroughdevelopmental evaluation, includingassessment of their adaptive and cog-nitive functioning, as they are at highrisk for .1 developmental disorder, 1of which may be ADHD.1 Such an as-sessment can be the first step towarda comprehensive plan for monitoringand intervention, one that should in-clude PBT as an important component.The evidence-based PBT interventionsincluded in this review improve par-enting skills and improve child dis-ruptive behavior, including coresymptoms of ADHD. Areas for furtherresearch include tailoring PBT inter-ventions to specific subgroups of chil-dren and families, and examiningbarriers to access and acceptance ofPBT interventions. Programs under

development that show promise in-clude combined PBT with behaviortraining for kindergarten personnel52

and combined PBT with a treatmentgroup for children.18 Where inattention,hyperactivity, and impulsiveness con-tinue to impair functioning after PBT,additional medical intervention may beconsidered. Use of methylphenidate inconjunction with PBT, as well as once-daily formulations, also requires fur-ther evaluation in preschoolers.

Children with more severe impairmentmay come to clinical attention at anearly age in part because of multipleconcurrent disorders; unfortunately,those with complex clinical syndromesappear less likely to benefit and morelikely to experience adverse effectsfrom methylphenidate. Community phy-sicians are in an excellent position toinitiate the assessments required,guide parents to evidence-based pro-grams where available, monitor theseconditions over time, and advocate forincreased resources in communitieswhere they do not yet exist.

APPENDIXES

APPENDIX A. SEARCH STRATEGIES

The complete search string is detailedbelow. Gray literatureand the referencelists of included articles were also ex-amined. In addition, study authorswerecontacted via E-mail for missing out-come or design data.

ADHD and Disruptive BehaviorDisorder Treatment SearchStrategies

Medline-OVID

November 23, 2011

1. “attention deficit and disruptivebehavior disorders”/ or attentiondeficit disorder with hyperactivity/or conduct disorder/

2. minimal brain d?sfunction*.tw,sh.

3. (attention deficit* or adhd).ti.

TABLE 5 Effectiveness of Interventions for Preschool-Aged Children with Disruptive Behavior,Including ADHD

Intervention SOE Conclusion

PBT HighSMD = –0.68

• Eight good RCTs showing efficacy for disruptive behaviors,including ADHD, and for parenting skills

95% CI: –0.88 to –0.47 • Benefits maintained• Dose effect• No adverse effects reported

Methylphenidate Low • One good RCT showing efficacy for ADHD behaviorsSMD = –0.83 • Adverse effects are reversible95% CI: –1.21 to –0.44

Combination homeand school/daycare

• Few reportsInsufficient • Programs highly variable

ADHD, attention-deficit/hyperactivity disorder; CI, confidence interval; PBT, Parent behavior training; SMD, standardizedmeandifference; SOE, strength of evidence.

REVIEW ARTICLE


4. addh.tw.

5. or/1-4

6. Hyperkinesis/

7. Impulsive Behavior/

8. Child Behavior Disorders/

9. aggression/ or agonistic behav-ior/

10. inattent*.tw.

11. Impulse Control Disorders/

12. (disruptive adj4 disorder?).tw.

13. or/5-12

14. limit 13 to (“newborn infant (birthto 1 month)” or “infant (1 to 23months)” or “preschool child (2 to5 years)”)

15. (preschool* or pre-school*).ti.

16. 13 and 15

17. 14 or 16

18. limit 17 to english language

19. animals/ not humans/

20. 18 not 19

21. limit 20 to (case reports or com-ment or editorial or in vitro or let-ter or news or newspaper articleor video-audio media or webcasts)

22. 20 not 21

23. limit 22 to ed=20100531-20111123

Embase-OVID

November 23, 2011

1. attention deficit disorder/



4. addh.tw.

5. or/1-4

6. hyperactivity/

7. disruptive behavior/

8. conduct disorder/

9. oppositional defiant disorder/

10. hyperkinesia/

11. aggression/ or aggressiveness/or anger/ or bullying/ or hostility/

12. impulsiveness/

13. inattention.tw.


15. or/5-14

16. limit 15 to (infant or child or pre-school child ,1 to 6 years.)

17. limit 16 to (book or book series orconference paper or editorial orletter or note)

18. 16 not 17


20. limit 19 to em=201021-201146

PsycINFO-OVID

November 24, 2011

1. attention deficit disorder/ or at-tention deficit disorder with hy-peractivity/



4. addh.tw.

5. or/1-4

6. conduct disorder/

7. aggressive behavior/

8. impulsiveness/

9. exp impulse control disorders/

10. oppositional defiant disorder/

11. distractability/

12. attention span/

13. hyperkinesis/

14. inattent*.tw.


16. or/5-15

17. limit 16 to childhood


19. limit 18 to (chapter or “column/opinion” or “comment/reply” oreditorial or letter or review-book)

20. 18 not 19

21. limit 20 to up=20100501-20111124

Cochrane Controlled Trial Registry-OVID

November 24, 2011

1. “attention deficit and disruptivebehavior disorders”/ or attentiondeficit disorder with hyperactiv-ity/ or conduct disorder/



4. addh.tw.

5. or/1-4

6. Hyperkinesis/

7. Impulsive Behavior/

8. Child Behavior Disorders/

9. aggression/ or agonistic behav-ior/

10. inattent*.tw.

11. Impulse Control Disorders/


13. or/5-12

14. limit 13 to yr=”2010 -Current”

15. (child* or pediatric* or paediat-ric* or pre-school or preschool).ti,jn.

16. 14 and 15

APPENDIX B. DETAILS REGARDINGEVALUATION OF INDIVIDUALSTUDIES

The Effective Public Health PracticeProject Quality Assessment Tool forQuantitative Studies Risk of Bias,13

evaluates a range of study designs:RCTs, observational studies, and beforeand after studies, with RCTs assigneda better score.14 Numeric values (1, 2,or 3) representing good, fair, or poorquality are assigned to items evaluat-ing the following domains: selectionbias, study design, confounders, datacollection methods, withdrawals anddropouts, reliability and validity ofoutcome measures. Scores in eachdomain are averaged, and subjectiveimpressions of intervention integrityand analytic methods also contributeto global ratings of study quality, cate-gorized as “good,” “fair,” or “poor”.14

For this review, blind evaluation ofoutcomes was not included as a re-quirement for a good study, as thebody of literature routinely dependson parent- and teacher-report out-come measures. Where study reports


described blinded outcomes, inter-vention integrity, and use of intent-to-treat analyses, these increased ratingsof study quality. Any disagreementsbetween 2 raters were resolved bya third rater.

APPENDIX C. DETAILS REGARDINGDATA SYNTHESIS

Study results were pooled to estimateoverall effect of intervention on both

outcomes of interest, parent-reportedchild disruptive behavior, includingsymptoms of ADHD, and on parent-reported parenting skills. We used theDerSimonian and Laird random effectsmodel with inverse variance method togenerate the summary effect estimatesin the form of SMD for each outcome.74

This model was preferred because ofthe presence of clinical and methodo-logical diversity across included stud-ies. The SMD was used as a summarystatistic because all the studies in thesystematic review assessed similaroutcomes but used different instru-ments tomeasure outcomes. The overallSMD for each outcome was calculatedby finding the difference of differencesbetween mean baseline and outcomevalues for intervention and control

groups, standardized against pooledSDs by using Microsoft Excel 2010. Seeequation below. SMDs were calculatedusing the assumption that baseline andoutcome values were correlated witheach other, with a correlation factor= 0.3, chosen following sensitivityanalysis of potential correlation fac-tors (0.0, 0.3, 0.5) in which estimates ofeffect were found to be essentially un-changed. Between-study heterogeneitywas quantified with the I2 statistic and

evaluated using the Cochran Q test,where P , .10 indicates a high level ofbetween study heterogeneity.75

The SDs for the mean differences be-tween baseline and outcome values ofintervention and control groups werecomputed using the following equation:

Where, SDchange = SD of mean differ-ence (baseline and outcome values),

SDBaseline = SD of baseline value,

SDFinal = SD of outcome value,

Corr = Correlation between baselineand outcome values.

ACKNOWLEDGMENTSThe authors are grateful to the entireresearch team that assisted with thereport: Lynda Booker, BA; Behnoosh

Dashti, MD, MPH; Mary Gauld, BA;Emanuela Yeung, BSc(H); Erin Lillie,BSc(H),MSc; JinhuiMa,MSc; ParminderRaina, BSc, PhD; and Russell Schachar,MD, FRCP(C). We are grateful to our keyinformants and members of the Techni-cal Expert Panel who were instrumentalin the formation of the parameters andgoals of this review: Lisa Clements,PhD; Jaswinder Ghuman, MD; GeorgeDuPaul, PhD; Lilly Hechtman, MD, FRCP(C);Margaret Weiss, MD, PhD, FRCP(C);Stephen Faraone, MD, PhD; William EPelham Jr, PhD; L. Eugene Arnold,MD, MEd; Laurence L. Greenhill, PhD,MD; and Julie Zito, PhD. We also thankthose who reviewed the draft of theoriginal report: L. Eugene Arnold, MD,MEd; Lisa Clements, PhD; Laurence L.Greenhill, PhD, MD; John Ratey, MD; Mag-gie Toplak, PhD; and Julie Zito, PhD.

We also thank those who worked soconscientiously retrieving and screen-ing citations, abstracting data, prepar-ing figures, and editing the report:Bryan Cheeseman, Roxanne Cheese-man, Alicia Freeborn, Connie Freeborn,Jeffrey Freeborn, Mary Gauld, MahbubulHaq, Suzanne Johansen, Sara Kaffashian,Dorothy Kendry, Jinhui Ma, LeahMacdonald, Sandra McIsaac, RachaelMorris, Galatea Papageorgiou, MaureenRice, Robert Stevens, and Ian White. Ourthanks to Drs Michael Boyle and HarryShannonandMsNancySantesso forpro-viding assistance along the way.

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(Continued from first page)

Address correspondence to Alice Charach, MD, MSc, FRCP(C), c/o Department of Psychiatry, Hospital for Sick Children, 555 University Ave. Toronto, Ontario, M5G 1X8,Canada. E-mail: [email protected]

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright © 2013 by the American Academy of Pediatrics

FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.

FUNDING: This report is based on research conducted by the McMaster Evidence-based Practice Center under contract to the Agency for Healthcare Research andQuality, Rockville, MD (Contract No. MME2202 290-02-0020).


mailto:[email protected]

RSV Policy Statement —Updated Guidance for Palivizumab Prophylaxis AmongInfants and Young Children at Increased Risk of Hospitalization forRespiratory Syncytial Virus Infection. Pediatrics 2014;134(2):415–420

An error occurred in the policy statement from the American Academy of Pedi-atrics titled “Updated Guidance for Palivizumab Prophylaxis Among Infants andYoung Children at Increased Risk of Hospitalization for Respiratory Syncytial VirusInfection” published in the August 2014 issue of Pediatrics (2014;134[2]:415–420).On pages 417–418, the last sentence in the section titled Use of Palivizumab inthe Second Year of Life should read: “A second season of palivizumab prophylaxisis recommended only for preterm infants born at ,32 weeks, 0 days’ gestationwho required at least 28 days of oxygen after birth and who continue to requiresupplemental oxygen, chronic systemic corticosteroid therapy, or diuretic therapywithin 6 months of the start of the second RSV season.” Bronchodilator therapy hasbeen removed as a consideration for prophylaxis in the second RSV season.

We regret this error.

doi:10.1542/peds.2014-2783

Veres et al. Duodenal Ulceration in a Patient With Celiac Disease andPlasminogen I Deficiency: Coincidence or Cofactors? Pediatrics. 2011;128(5):e1302–e1306

An error occurred in the article by Veres et al, titled “Duodenal Ulceration in a PatientWith Celiac Disease and Plasminogen I Deficiency: Coincidence or Cofactors?” pub-lished in the November 2011 issue of Pediatrics (2011;128[5]:e1302–e1306; doi:10.1542/peds.2010-2251). On page e1302, the list of authors reads: “Gabor Veres, MD, PhD,a

Ilma Korponay-Szabó, MD, PhD,b Erika Maka, MD,c Tibor Glasz, MD, PhD,d Petar Mamula,MD,e Maria Papp, MD, PhD,f Antal Dezsöfi, MD, PhD,a and Andras Arató, MD, Dsca”.

The list of authors should have read: “Gabor Veres, MD, PhD,a Ilma Korponay-Szabó, MD, PhD,b Erika Maka, MD,c Tibor Glasz, MD, PhD,d Petar Mamula, MD,e

Maria Papp, MD, PhD,f Antal Dezsöfi, MD, PhD,a Volker Schuster, MD,g Katrin Tefs,PhD,g and Andras Arató, MD, Dsca”.

The author affiliations should have included: “gChildren’s Hospital, University ofLeipzig, Germany”.

doi:10.1542/peds.2014-2897

Charach et al. Interventions for Preschool Children at High Risk for ADHD:A Comparative Effectiveness Review. Pediatrics. 2013;131(5):e1584–e1604

An error occurred in the article by Charach et al, titled “Interventions for PreschoolChildren at High Risk for ADHD: A Comparative Effectiveness Review” published in theMay 2013 issue of Pediatrics (2013;131[5]:e1584–e1604; doi:10.1542/peds.2012-0974).Starting on page e1592, under the PATS heading within the Results section, thisreads: “Methylphenidate improved core parent-rated and teacher-rated ADHDsymptoms during the within-subject crossover titration phase with a mean opti-mal single dose of 0.7 1/2 0.4 mg/kg, and with a mean optimal total daily dose of14.2 1/2 8.1 mg/kg/day.”

This should have read: “Methylphenidate improved core parent-rated and teacher-rated ADHD symptoms during the within-subject crossover titration phase with

ERRATA

PEDIATRICS Volume 134, Number 6, December 2014 1221

ERRATA

a mean optimal single dose of 0.7 1/2 0.4 mg/kg, and with a mean optimal totaldaily dose of 14.2 1/2 8.1 mg/day”.

doi:10.1542/peds.2014-3027

Whittingham et al. Interventions to Reduce Behavioral Problems in ChildrenWith Cerebral Palsy: An RCT. Pediatrics. 2014;133(5):e1249–e1257

A production error occurred in the article by Whittingham et al, titled “Inter-ventions to Reduce Behavioral Problems in Children With Cerebral Palsy: An RCT”published in the May 2014 issue of Pediatrics (2014 May;133[5]: e1249–e1257;doi:10.1542/peds.2013-3620). On page e1257, the Financial Disclosure should haveread: “As coauthor of the Stepping Stones Triple P program, Dr. Sanders receivesroyalty payments from Triple P International, in accordance with the Universityof Queensland Intellectual Property Policy; the other authors have indicated theyhave no financial relationships relevant to this article to disclose.”

doi:10.1542/peds.2014-3029

1222 ERRATA

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