GayaJ.Dowling,Ph.D.Director,ABCDProject

DivisionofExtramuralResearch,NIDAFebruary11,2016

AnNIHCollaboration:NIDA,NIAAA,NCI,NIMH,NIMHD,NICHD,NINDS,OBSSR

Alongitudinalstudyofabout10,000childrenfromages9-10throughearlyadulthoodtoassessfactorsthatinfluenceindividual

braindevelopmenttrajectoriesandfunctionaloutcomes

ResearchObjectives• Identification of individual developmental trajectories (e.g., brain,

cognitive, emotional, academic), and the factors that can affect them.

• Development of national standards of normal brain development in youth.

• The role of genetic vs. environmental factors on development, enriched by comparisons of twin participants (800 pairs will be recruited into the study).

• The effects of physical activity, sleep, screen time, as well as sports and other injuries on brain development and other outcomes.

• The onset and progression of mental disorders, factors that influence their course or severity, and the relationship between mental disorders and substance use.

• How exposure to different substances like alcohol, marijuana, nicotine, caffeine, and others, individually or in combination, affect various developmental outcomes and vice versa.

HowDidWeGettoWhereWeAreToday?

üExpertpanelworkshoptodeveloprecommendationsonbestlarge-scaledesignsandmeasurestoassessdevelopmentaleffectsofsubstanceexposure.May27-28,2014

üARequestForInformation togetinputonproposedstudydesign/measures.July-August,2014

üRevised design basedoninputfromRFIanddiscussionatSfN satellitesymposium.October,2014

üFOAsreleased:U24—CoordinatingCenter,DataAnalysisandInformaticsCenter;U01Researchsites.January,2015

üRobustresponsetotheFOAs;applicationsreviewedJuly,2015

üGrantsawarded:13awards:1CC,1DAIC,11ResearchGrants(19ResearchSites)Sept,2015

üFirstPImeeting.Oct,2015

AdolescentBrainCognitiveDevelopmentStudySites

Research Hub

Additional Recruitment Site

Coordinating CenterData Analysis & Informatics Center

Coordinating CenterPDs: T. Jernigan|S. BrownADs: S. Tapert| H. Garavan

University of California, San DiegoLa Jolla, CA

Data Analysis & Informatics CenterA. Dale

University of California, San Diego

La Jolla, CA

I. ColrainSRI International Menlo Park, CA

T. Ernst|L. Chang|T. WillsUniversity of Hawaii

at ManoaHonolulu, HI

D. ClarkUniversity of Pittsburgh

Pittsburgh, PA

R. GonzalezFlorida International University

Miami, FL

D. Yurgelun-Todd| P. Renshaw

University of UtahSalt Lake City, UT

W. Iacono|M. LucianaUniversity of Minnesota

Minneapolis, MN

M. Banich|J. HewittUniversity of Colorado Boulder & Aurora, CO

B. CaseyWeill Medical College of Cornell

UniversityNew York, NY

R. GoldsteinIcahn School of Medicine

at Mount SinaiNew York, NY

J. Bjork|M. NealeVirginia Commonwealth University

Richmond, VA

D. Barch|A. Heath| P. Madden

Washington University St. Louis, MO

B. Nagel|D. Fair|S. Ewing Oregon Health & Science University

Portland, OR

H. GaravanUniversity of Vermont

Burlington, VT

E. SowellChildren’s Hospital of Los Angeles

Los Angeles, CA

S. BookheimerUniversity of California, Los Angeles

Los Angeles, CA

S. TapertUniversity of California, San

DiegoLa Jolla, CA

M. PaulusLaureate Institute for Brain

Research Tulsa, OK

M. Heitzeg|R. ZuckerUniversity of Michigan

Ann Arbor, MI

L. Cottler|S. NixonUniversity of Florida

Gainesville, FL

StructureOrganization

Function

ABCDGovernanceStructure

Providesscientificassistance,guidance,and

coordination

NIHABCDCollaboratorsGroupNIDA,NIAAA,NCI,NIMH,NIMHD,NICHD,NINDS,OBSSR

NIHScienceOfficials

KevinConway

JohnMatochik

SteveGrantAntonioNoronha

NIHScienceOfficials

OSMBClinicalRiskManagement

19ResearchSites

CoordinatingCenter

DataAnalysis &InformaticsCenter

SteeringCommitteeVotingMembers:CC,DAIC,SitePIs(subset),NIH(1vote)

Non-votingmembers: otherNIHstaffDecisionMakingBody

ProgramOfficialBethanyDeeds

Project DirectorGayaDowling

ExternalAdvisoryBoardMakesRecommendations

OperationsGroupCCDirs andAssoc Dirs,DAICDir

NIHPD andDAICWorkgroupLDRsImplementationGroup

CouncilofInvestigatorsCC,DAIC,SitePIs,NIHPO,NIHPD,NIHSOs

Providesprogrammaticassistance,guidance,and

coordination

ABCDExternalAdvisoryBoard• Role:Toprovidescientificandadministrativeoversightthroughoutthe

studycourse,including:• Reviewstudyprotocolbeforeinitiation• Assessprogressandrelatedactivities• Suggestmodificationstothescopeoftheresearchprogramifneeded• Consultonrecruitmentandretentionofnewscientificstaffandfaculty• Representandcommunicatecommunityinterestsandviews.

• TheEABwillproviderecommendationstotheABCDSteeringCommitteeandtheNIHregardingscientificprogramandactivities.

• Composition:Nationalexpertsinrelevantfieldsandscientificareascriticaltostudydesignandimplementation.

ABCDObservationalStudyMonitoringBoard

• Role:TheprincipalroleoftheOSMBistomonitorregularlytheobservationalstudyandmakerecommendationstotheNIHwithrespectto:• Participantsafety,confidentiality,andinformedconsent, includingnotificationofand

referralforabnormalfindings• Participantburden• Impactofproposedancillarystudiesandsub-studies onparticipantburdenandoverall

achievementofthemainstudygoals

ABCDFunctionalOrganization

19ResearchSites

CoordinatingCenter

DataAnalysis&Informatics

Center

Design&Biostatistics

ImageAcquisition

ResourceSharing&Publications

ImageAnalysis

Informatics

AssessmentGroups• SubstanceUse• Neurocognition• Health&MentalHealth• Culture &Environment• Biospecimen &Dev.Biomarkers• MobileTechnology

AdvisoryGroupsBioethics andMedicalOversight|Development,Risk,Resilience |EmergingScientific Opportunity |Community AdvisoryCouncil

StandingCommitteesProfessional Development|OutreachandDissemination

NIHscientific andprogrammatic collaborators

OperationsGroupCCDirs andAssoc Dirs,DAICDir,NIHPD,andDAICWorkgroupLDRs

ImplementationGroup

NIHCollaborators• Aklin,Will(NIDA)• Alderson,Carol(NIDA)• Arroyo,Judith(NIAAA)• Anderson,Kathleen(NIMH)• Avenevoli,Shelli(NIMH)• Babcock,Debra(NINDS)• Bloch,Michele(NCI)• Boyce,Cheryl(NIDA)• Bradley,Eileen(CSR)• Conway,Kevin(NIDA)• Deeds,Bethany(NIDA)• Dowling,Gaya(NIDA)• Durrant,Valerie(CSR)• Elwood,Bill(OBSSR)• Etz,Kathy(NIDA)• Farber,Greg(NIMH)• Finger,Matt(NIDA)• Fleming,Pam(NIDA)

• Freund,Lisa(NICHD)• Friedman-Hill,Stacia

(NIMH)• Frascella,Joe(NIDA)• Glantz,Meyer(NIDA)• Grant,Steve(NIDA)• Gray,Kimberly(NIEHS)• Gust,Steve(NIDA)• Horowitz,Todd(NCI)• Howlett,Katia(NIDA)• Hunt,Yvonne(NCI)• James,Regina(NIMHD)• Jones,Donna(NIDA)• Kimmel,Heather(NIDA)• Little,Roger(NIDA)• Lopez,Marsha(NIDA)• Matochik,John(NIAAA)• Montoya,Ivan(NIDA)

• Morgan,Glen(NCI)• Murray,Peggy(NIAAA)• Noronha,Antonio(NIAAA)• Pariyadath,Vani(NIDA)• Pierpaoli,Carlo(NICHD)• Radman,Tom(NIDA)• RubenAlvarez(NICHD)• Simmons,Janine(OBSSR)• Spittel,Mike(OBSSR)• Swieter,Mark(NIDA)• Warren,Ken(NIAAA)• Weinberg,Naimah(NIDA)• Weiss,Susan(NIDA)• Willis,Gordon(NCI)• Winn,Debbie(NCI)

ABCD Protocol

DesignandRecruitmentProtocolRecruitment Strategy (school-based strategy for non-twins)• Sampling statisticians from the University of Michigan Institute for Social

Research (ISR) will identify all public and private schools with kids aged 9-10 within geographic catchment area for each site.

DesignandRecruitmentProtocolRecruitment Strategy (school-based strategy for non-twins)• Begin by engaging schools for their support.• Schools do initial mailshot to families of 9/10 year olds.• Interested families contacted by site.• Screen with parent/guardian.• Screen eligible youth.• Screener assesses inclusion/exclusion criteria (aim is to be very

inclusive)

Twin Cohort (800 pairs)• Four sites (Colorado, Minnesota, Missouri, Virginia)• Birth registry records

BaselineAssessmentProtocol

CurrentTimeline

NIDAABCDwebsite- http://tinyurl.com/ABCDStudyCRANABCDwebsite- http://addictionresearch.nih.gov/adolescent-brain-

cognitive-development-study