Part 1: About the Intervention Program - McGill University · Part 1: About the Study 2 social...

Part 1: About the Study

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This project is funded by the Public Health Agency of Canada and is being conducted jointly by researchers from different universities. We want to implement an intervention program that focuses on improving family heath and improving resilience of individuals and families. We hope that this program will have a positive effect on family cohesion and communication, and preventative effect for suicide as well as for other mental health problems.

Purpose of the Intervention

Family-oriented approaches have been shown to be effective in reducing behavioral and emotional problems and in promoting resilience in children and adolescents.

The intervention also focuses on strengthening the resilience of individuals and families. Resilience has been located in specific psychological characteristics of individuals associated with hardiness, flexibility, problem solving ability, and the capacity to cope with adversity. At the level of family and community, resilience may reside in the durability of interpersonal relationships in the extended family and wider social networks of support. Ideas of resilience are grounded in local cultural values that have persisted despite historical adversity or have emerged out of the revival of Indigenous identities; these include, the importance of an individual’s relationship to the land, a community’s ability to maintain its Indigenous language, or to resist marginalization and external control and assert collective political agency.

The intervention focuses on a culturally specific approach to strengthening family interactions, teaching parenting skills, teaching

Part 1:Part 1: About the About the Intervention Intervention ProgramProgram


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social skills, refusal skills, and coping mechanisms to both adolescents and parents, and re-connecting the generations through interactions and participation of community elders. Community involvement is critical. Communities will receive materials and support to develop their own version of the program, incorporating local cultural values and addressing specific issues they prioritize in addition to the core elements of the program. This type of comprehensive approach needs considerable modification to be age appropriate, culturally relevant, and logistically feasible in Aboriginal communities.

Recent studies have shown correlations between multiple indicators of individuals' cultural involvement (e.g., traditional spirituality, traditional activities, and cultural identity) and a variety of positive mental health indicators including pro-social behavior in adolescents, reduced depressive symptoms in adults, and less alcohol abuse among adults. Work with Anishinabe adolescents indicates that cultural knowledge and identification is associated with less suicidal ideation and depressive symptoms and with greater self-esteem. Other work suggests that a ‘cultural spiritual orientation’ is associated with fewer suicide attempts.

An initial implementation of this intervention targeted 5th-8th grade Anishinabe children and showed promising results for younger children (aged 10-12 years) who had not yet begun to experiment with alcohol or drugs. At one-year follow-up, logistic regression analyses controlling for gender and age showed that adolescents who had graduated from the intervention and who had not yet begun drinking alcohol were significantly less likely to initiate this behavior than were controls. Younger children benefited more from the intervention than did the oldest age group.”

About the Intervention Program

The intervention program will be 14 weeks long, with one session each week:

Overview of the Sessions:

• Week 1: Opening Feast

• Week 2: Community History

• Week 3: Family

• Week 4: A Good Way of Life

• Week 5: Working Together

• Week 6: Living in Harmony

• Week 7: Balance

• Week 8: Problem Solving


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• Week 9: Making choices

• Week 10: Communication

• Week 11: Valuing differences

• Week 12: Social Support

• Week 13: Empowerment

• Week 14: Celebration Feast

Knowing how to lead or facilitate group-based discussions and activities doesn't happen overnight. It is something that you will get better and better at doing each time you try. The following section will provide tips and techniques to help you to develop your skills as a program facilitator

After you finish this section, you should be able to do the following:

ü Understand a facilitators most important tasks

ü Understand what make an effective facilitator

ü Identify ways to establish trust and rapport with respondents

ü Identify ways to effectively facilitate the mental health promotion program

ü Understand how to prepare and administer the sessions

A Facilitator’s Most Important Tasks

Facilitators play a very important role in this program. You are responsible for administering the prevention/mental health promotion program and engaging with the participants. Essentially, you are a teacher and your goal is to stimulate thinking, reflection, and understanding about the session topics. Facilitators should also strive to create and maintain a positive learning environment, where all participants feel comfortable and free to express their opinions, feelings, and thoughts.

Part 2:Part 2: FacilitatingFacilitating TechniquesTechniques

Part 2: Facilitating Techniques

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Although some of the content in the manual may feel emotional and bring out deep feelings in participants, your job is not to serve as therapists/counselors. Instead, if you encounter distressed or upset participants you should refer to the safety plan discussed during training and written in the facilitator manual in the preparation Section.

What Makes a Good Facilitator?1

An effective facilitator is: • Prepared • In charge without

being overly controlling

• Respectful of the Learners, their knowledge and skills

• Trusting • Tolerant of ambiguity • Patient • Empathetic • Grounded—aware of his or her

personal philosophy, values, and biases

• Sensitive and aware

• Flexible • Non-

judgmental • Energetic

An effective facilitator has:

• Knowledge of his or her subject

• Technical skills • A sense of humor • Awareness of time factors • Ability to multitask

• A willingness to lead • Awareness that he or she does not

“know it all” • A strong sense of commitment to the

purpose, the “why” of the subject

Ensuring Respondent Confidentiality

It is important for this prevention program to be as effective as possible, so you want participants to give truthful answers in discussions and on homework assignments. The best way to ensure truthful answers is for you to guarantee that the information they provide will be kept completely confidential by the research or program team.

There are several ways to protect your respondents' confidentiality and help them understand that you won't misuse the information they share:

1. Inform respondents that you have signed a confidentiality pledge. With this you promised to keep their private information protected. This includes information leading to the identification of any study participants, questions, session materials, individual participant responses and research results,

1 This section adapted from the Diabetes Today Supplement Trainer’s Toolkit as found in Native H.O.P.E. Training of Facilitators Manual, http://www.oneskycenter.org/pp/documents/NativeHopeYouthTrainingManual_000.pdf


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and unpublished research results.

2. Don't discuss details of the sessions outside of the work environment. Although discussion of participant information among project staff is sometimes a necessary part of the process, do not disclose prevention program information with family, friends, or anyone else not involved with the project.

3. Store your materials in a locked (or secure) area when you are not at work. Do not leave confidential materials on desks or tables overnight. Never leave program materials (e.g., respondent names or homework assignments with respondent names) in a car or in an unsecured bag or purse. Keep all materials in a locked filing cabinet at the agency until it is sent back to the university to be processed.

4. Remind respondents of their own responsibility to respect each other’s privacy. Encourage participants to keep private information that they may learn about other participants private.

Tips for Effective Facilitation2

1. Prepare yourself o Gain as much understanding in advance as possible about the

group you are facilitating. o Think through the issues that may arise in the facilitated

session and plan how you will respond.

2. Fine-tune your skills o The key skills for facilitation are listening, summarizing

discussion and identifying ways to move the discussion forward.

3. Organize o As a facilitator you must have a very clear understanding

of what needs to be accomplished by the end of the session and the means you will use to guide the group to this end. The first few pages of each week of the manual will help you with this task.

4. Start off on the right foot o Ensure that all participants have a common understanding of

the purpose and intended results of each session (for each session, look at the objectives).

o An introductory exercise is advisable as it breaks the ice and allows you to develop rapport with the group. The first three sessions of the program have an icebreaker

2 This section was taken or adapted from the Canadian Mental Health Association, http://cmha.ca/data/1/rec_docs/556_CMHA_trainthetrainer_EN.pdf


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activity, and subsequent weeks have an optional icebreaker activity.

5. Build trust o For effective facilitation, the group must trust you. For

trust to develop, you must be genuine in your interest and desire to make the facilitated session beneficial for participants. One way to develop trust, as already stated, is to ensure participant confidentiality.

6. Strike a balance o There is a balance to strike between giving people time to

express themselves and keeping the process on track.

7. Keep the mood light o Humor is important. It is a non-offensive way for

participants in a group to see issues or acknowledge problems.

8. Watch group vibes and body language o If people seem bored or inattentive, you may have to speed

up the pace of the meeting. If people seem tense because of unvoiced disagreements, you may have to bring concerns out into the open.

9. Ask open-ended questions o Effective open-ended question will provide participants

with the opportunity to share their experience and knowledge with the group, and helps to get necessary feedback.

10. Be neutral o You should act in a nonjudgmental, noncommittal, and

objective attitude. This will help participants feel comfortable answering questions truthfully and completely. Nothing in your words or manner should imply criticism, surprise, approval, or disapproval of either the questions or answers. In addition, avoid any response or even a sound that could be mistaken as a judgment call.

11. Set and follow ground rules o Developing group rules with the group and sticking to them

helps to create an environment in which everyone feels comfortable participating. Common ground rules include: One person speaks at a time; Listen to what other people are saying; Respect other people’s ideas; Have a system to keep track of speakers—to make sure everyone is heard, and that no one dominates to the exclusion of others.

12. Encourage participation


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o Involve everyone in the sessions. This includes drawing out quiet and controlling the domineering ones.

13. Summarize results and needed follow-ups o Remind participants how much good work was done and how

effective the meeting was. Refer back to the objectives for each session to show how much you accomplished and to emphasize key points.

14. Don’t memorize a script

o Even with a well-prepared agenda and key points you must make, you need to be flexible and natural. If people sense that you are reading memorized lines, they will feel like they are being talked down to, and won’t respond freely.

15. Don’t talk to the flipchart, blackboard, or walls—They can’t talk back

o Always wait until you have stopped writing and are facing the group to talk.

16. Don’t be defensive o If you are attacked or criticized, take a “mental step”

backwards before responding. Once you become defensive, you risk losing the group’s respect and trust, and might cause people to feels they can’t be honest with you.

Preparation and Administering the Sessions

It is your responsibility as a facilitator to come to each session prepared. Spend a few hours reviewing the material for each week’s session BEFORE you arrive at the scheduled session time. In addition, you should always have at least one co-facilitator. You will need to coordinate and practice with one another ahead of time. You will also want to make sure you check all your materials to ensure you have everything you need for that week’s activities. This includes reviewing handouts, homework, supplies, and any special items you may need that week (i.e., board games, shawls, puzzles, etc.). To help you with this process, the first few pages of each session include a checklist, a list of materials needed, and how to prepare for each week.

Facilitators are responsible for keeping the session running on time and completing all the assigned tasks for each session. Each activity/discussion has a suggested time limit. You can also get an overview of the timing for each section by looking at the first few pages of each session.


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This program includes a scientific evaluation, which means that it is IMPORTANT THAT EACH SESSION IS CONDUCTED THE SAME ON ALL RESERVES. Deviations from the session guidelines can affect the results of the trial and invalidate the findings.

It is important that you do the following:

• Follow the session agenda and distribute the required information.

• Conduct sessions in the exact order in which they appear on the agenda.

• Do not skip any activities. • Remain objective—do not indicate surprise, pleasure, or

disapproval at any of the participant’s answers. • Be courteous and polite, even if the participant is rude to you.

ü This section will outline the session topics and schedule.

ü After you finish this section, you should be able to do the following:

ü Understand the basic topics that will be covered and the order in which they will be covered.

Session 1: Welcoming Feast The first session of the program will be a welcoming feast. In this session, the facilitator will be responsible for welcoming everyone, discussing consent forms, introducing the Elder guest speaker, facilitating the group icebreaker activity, discussing the handout “Program Welcome” and the handout “My Family’s Values”, showing the video “Our Family, Our Culture” (or scheduling a guest speaker on the topic of family and culture), and facilitating a youth activity and a parent activity. At the end of the session, the participants will receive homework and take family pictures. Of course, the facilitator should be sure to thank the families for their participation.

Part 3: Part 3: The SessionsThe Sessions

Part 3: The Sessions Part 3: The Sessions Part 3: The Sessions Part 3: The Sessions

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At the end of Session 1, participants should understand the major protocols of the program and program incentives, and they should also be thinking about their family, values, and culture.

Session 2: Community History The facilitator will begin the second session by welcoming everyone and discussing any questions that participants might have had from the previous week’s session. Again this week, the facilitator will lead an icebreaker activity, a discussion with parents and youth, distribute worksheets and show a video (or schedule a guest speaker) about Ojibwe History. There will also be a youth journal activity and a parent discussion. At the end of the session, the facilitator will distribute handouts and homework concerning Talking Circles. At the end of Session 2, participants should be thinking about Anishinabe history and also be clear on the instructions for their homework assignments.

Session 3: Family

The third session focuses on “My Family”, family talking circles, and traditional Anishinabe families. At the beginning of the third session, the facilitator will welcome all of the participants, discuss any questions they have concerning last week’s session on Anishinabe History, and facilitate a discussion reviewing last week’s materials. Then they will lead the usual icebreaker activity, and distribute the parent and youth handouts about family talking circles and The Traditional Anishinabe Family Story for discussion. Then, the facilitator will facilitate the youth journal activity and the parent activity focused on Skills for Living. Again this week, at the end of the session the facilitator will distribute and explain homework that will be due at the following session.

By the end of the third session, participants should be thinking about their own families, how talking circles could be used as a tool for coping with stress and bonding with their family, and understand the expectations for their homework assignment.

Session 4: A Good Way of Life

The fourth session focuses on the stages of life and living a good life. At the beginning of the fourth session, the facilitator will welcome all of the participants, discuss any questions they have concerning last week’s session on “My Family” and discuss the homework that is due this week. This week, the usual icebreaker activity is


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optional. The facilitator should use their judgment about whether they would like to use the icebreaker this week. Next, the facilitator will show the DVD “Minobimaadiziwin: A Good Way of Life”. Then, the facilitator will distribute and discuss two handouts about stages of life and a good way of life with both the parents and youths. This session includes a board game, Minobimaadiziwin. The facilitator will be responsible for distributing the games to each family and explaining the rules to the room. While families are playing, the facilitator should take pictures. After the game play is finished, there should be a discussion about the game.

The session will conclude with a parent and youth journal activity. The participants will be given homework concerning the Minobimaadiziwin game.

By the end of the fourth session, participants should be thinking about their own lives, how their choices affect the quality of their lives, and understand the instructions for the following homework assignment.

Session 5: Working Together

The fifth session focuses on understanding, identifying, and exploring feelings, problems, and resources that could be used to solve these problems. At the beginning of the fifth session, the facilitator will welcome all of the participants, discuss any questions they have concerning last week’s session on “A Good Way of Life”, and briefly discuss the homework that is due this week. The icebreaker activity is optional.

Next, the facilitator will lead a puppet show. Then, the facilitator will distribute puppet-making materials and puppet show scripts to the youth. There will also be a journal activity. Facilitators will need to distribute family strengths evaluations and family goals sheets to the parents, and then facilitate a discussion about them while the youth are building their puppets. Parents and their kids will then perform the puppet show. The session will also include a DVD and a discussion about the DVD’s message. The session will end with the distribution of homework. In this session, participants will discuss feelings and ways to cope with some of these negative feelings that they may be having. Facilitators should be ready if any participant becomes extremely upset (refer to protocols in Part 3 of this manual).

By the end of the fifth session, participants should be thinking about their feelings, problems, and healthy methods of solving these problems.


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Session 6: Living in Harmony

This session focuses on being healthy and establishing healthy relationships. At the beginning of this session, the facilitator will welcome all of the participants and briefly discuss any questions they have concerning last week’s session. Then, there will be a youth activity on cyberbullying, while the parents discuss dealing with cyberbullying. Then, the parents and youths will discuss sadness and depression together. Following this discussion, they will complete an “Openness Contract.” This is another session that includes sensitive topics. The facilitator should be especially aware of potentially distressed participants, and follow the protocols presented in Part 3.

By the end of the session, participants should be aware of cyberbullying and methods of coping with cyberbullying, as well as methods of coping with sadness and depression.

Session 7: Balance

This session focuses on anger and ways to manage anger. At the beginning of this session, the facilitator will welcome all of the participants, discuss any questions they have concerning last week’s session on “Help Seeking”. Then, there will be a parent and youth discussion, followed by a video called Nana’b’oozoo (or followed by a guest speaker about anger management). A discussion will follow the video or speaker. The youth activity this week will concern temper gauges. The parents will participate in a discussion and do a worksheet concerning anger.

Session 8: Problem Solving

The eighth session focuses on problem solving. At the beginning of this session, the facilitator will welcome all of the participants and briefly discuss any questions they have concerning last week’s session. Then, there will be a youth activity on STEPS to problem solving and traditional conflict resolution, followed by a journal activity. At the same time, parents will discuss information sharing, play a video or introduce a guest speaker, and also discuss STEPS problem solving. Then, the facilitator will distribute and explain next week’s homework assignment.

By the end of the eighth session, participants should understand the STEPS method to problem solving and information sharing.


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Session 9: Making Choices

The ninth session focuses on refusal skills and monitoring. As always, at the beginning of this session the facilitator will welcome all of the participants and discuss any questions they have concerning last week’s session. Then, there will be a game and discussion about refusal skills. At the same time, parents will watch a video called “Monitoring Our Children: Conversations with Elders” (or listen to a guest speaker about monitoring children) and discuss it. By the end of the session, youth participants should understand various methods of peer pressure and how to refuse it, and parents should learn methods of monitoring their children.

Session 10: Communication

The tenth session focuses on peer communication. As always, at the beginning of this session the facilitator will welcome all of the participants and discuss any questions they have concerning last week’s session. Then, there will be a youth activity and discussion about the qualities of friendship, followed by a journal activity. At the same time, parents will discuss the concepts of encouraging children and skills for living. At the end of the session, the facilitator will distribute a handout concerning preparing children for success.

By the end of the tenth session, youth participants should understand ways of communicating with peers that build healthy, happy friendships and parents should understand ways of encouraging their children to build these positive peer relationships.

Session 11: Valuing Differences

The eleventh session focuses on being different and addressing discrimination. As always, at the beginning of this session the facilitator will welcome all of the participants and briefly discuss any questions they have concerning last week’s session. Then, there will be a youth activity on culture trees and being different, followed by a discussion. At the same time, parents will discuss the concept of discussing hate and violence with children. Next, parents and youths will come together to do an anti-discrimination pledge and discussion.


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Session 12: Social Support

The twelfth session focuses on building social support. As always, at the beginning of this session the facilitator will welcome all of the participants and discuss any questions they have concerning last week’s session. Then, there will be a parent and youth activity and discussion about social support and personal mission statements.

By the end of the twelfth session, participants should have completed their personal mission statement and be aware of behaviors that build trust in relationships.

Session 13: Empowerment

The thirteenth session focuses on community strengths and empowerment. As always, at the beginning of this session the facilitator will welcome all of the participants and discuss any questions they have concerning last week’s session. Then, there will be a parent and youth discussion about community empowerment. After that, youths will participate in a drawing activity and parents will have a brainstorming session on community empowerment. At the end, parents and youths reconvene to make scrapbooks.

By the end of the twelfth session, participants should be thinking about their community, it’s strengths, and ways to improve it.

Session 14: Celebration Feast

The fourteenth session is a celebration feast. As always, at the beginning of this session the facilitator will welcome all of the participants and discuss any questions they have concerning last week’s session. Then, the facilitator will introduce the Elder guest speaker and direct participants to the food area. There will be a slideshow, a blanket ceremony, and an awards ceremony after the meal.

By the end of the thirteenth session, participants will have celebrated the conclusion of the program and have learned ways to incorporate things they have learned here into their daily lives. They will also have received gifts of appreciate for their participation in the program.

Part 4: Getting Feedback

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At the end of each session, coordinators will ask facilitators what they liked and didn’t like about the session. The main goal of obtaining this feedback is to tailor the program and make it more effective. This is a pilot prevention program, so this feedback is especially important to improving the content of future programs.

To Obtain Feedback during Weekly Conference Calls, Coordinators Should Do the Following:

1. Ask questions from the coordinator workbook. 2. Listen carefully and write answer in the Team Report. 3. Probe to gather additional responses.

At Session 11, facilitators might ask partipants:

- They could ask the following questions: o “What did you like about the program activities or lessons?”

(Youth: “What was fun?”) o “What did you learn? o “Was there anything about the sessions that you didn’t like?”

(Youth: “Did you think anything was boring?”) o “What would you do to improve (Youth: make the program better)?” o Adults only: “How do you think your child responded to the

program’s lessons?”

If participants give very general or short answers (e.g., “it was boring”), use probes like:

o “Can you tell me more about that?” o “What do you mean by that?”

- After it becomes clear that no one else has anything to say, thank them for their feedback and their participation, and turn off the tape recorder.

Part 4:Part 4: Getting FeedbackGetting Feedback


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During discussions in various session: Techniques to Pause and Probe3

The two most important moderator techniques are the five second pause and the probe. The five second pause is often used after a participant comment. This short pause often prompts additional points of view or agreement with the previously mentioned position. The second technique, the probe, is a request for additional information. In most conversations, there is a tendency for people to make vague comments that could have multiple meanings or to say “I agree.” When this occurs, the probe is an effective technique to elicit additional information. Typical Probes

o Would you explain further? OR Is there anything else? o Would you give me an example of what you mean? o Would you say more OR tell us more OR say more. o Please describe what you mean OR I don’t understand.

Moderators should use probes a few times early in the interview to communicate the importance of precise responses. For example, if a participant says “I agree”, the moderator should then follow up with, “tell us more,” or “What experiences have you had that make you feel that way?” This will give participants the impression that more detailed answers are wanted.

Participants may also need to be reminded of the value of differing points of view. If participants are simply “echoing” the same concept, a moderator could step in using probes. For example, after several echoes on the same idea, the moderator might ask, “does anyone see it differently?” or “Has anyone had a different experience?” or “are there other points of view?”

Additional Probes o Can you tell me more about …? OR What else can you tell me

about …? o That’s interesting. [Pause.] o What are you thinking? OR What do some other people in the

group think? o I hear you two are saying different things. Let’s talk

more about this. o Let’s go back to what someone said earlier about … o How would you summarize what you are saying?

3 Rohs, F. Richard. 2011. Reviewed by Nicholas Fuhrman. “Focus Groups.” The University of Georgia

Cooperative Extension. http://www.caes.uga.edu/applications/publications/files/pdf/MP%20418_3.PDF


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o I see you [insert facial expression]…what are you thinking? o I’d like to know/hear more about …?

How to Deal with Different Participant Personalities4

Shy Participants Shy respondents and reflective thinkers tend to say little. It seems that these participants think carefully first and then speak. By contrast, others in the group are thinking and speaking at the same time. Shy and reflective participants often have great insights, but it takes extra effort to get them to elaborate their views. If possible, the moderator should place shy respondents directly across the table to maximize eye contact. Eye contact often provides sufficient encouragement to speak, and if all else fails, the moderator can call on them by name. “Tom I don’t want to leave you out of the conversation. What do you think?”

Experts Self-appointed “experts” can present special problems in focus groups. What they say and how they say it can inhibit others in the group. Participants often defer to others who are perceived to have more experience or are better informed on a topic. Often the best way to handle experts is to underscore the fact that everyone is an expert and all participants have important perceptions that need to be expressed. In addition, the introductory question should avoid responses that would highlight participants’ levels of education, affluence, years of experience with the topic, or social or political influence.

Dominant Talkers Dominant talkers sometimes consider themselves to be experts, but much of the time, they are unaware of how they are perceived by others. Often dominant talkers are spotted in pre-session small talk. Try to seat dominant individuals near the moderator to exercise control by the use of body language. Also, moderators can verbally shift attention. For example, “Thank you, John. Are there others who wish to comment on the question? Or “Does anyone feel differently?” or “That’s one point of view. Does anyone have another point of view?” Other nonverbal techniques, like avoiding eye contact with the dominant talker, can be used. Most important, be tactful and kind, because harsh comments may curtail spontaneity from others in the group.

4 This section was taken or adapted from Krueger, Richard and Mary Anne Casey. (2000). Focus Groups: A Practical Guide for Applied Research (3rd Edition). Sage Publications, Inc.


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Ramblers

Rambling respondents use a lot of words and take forever to get to the point, if they have a point. These individuals like to talk. Unfortunately, the rambling respondent is off tract a fair amount of the time and can eat up precious discussion time. As a rule of thumb, we usually discontinue eye contact with the rambler after about twenty to thirty seconds. The assistant moderator should do the same. As soon as the rambler stops or pauses, the moderator should be ready to fire away with the next question or repeat the current question being discussed.

Knowing how to handle difficult situations during sessions takes careful thought and training. Nothing is as scary as someone expressing suicidal thoughts. One of the most important skills you can learn as a facilitator is how to stay calm and assess these situations.


ü Provide participants with proper resources

ü Understand the protocol for instances when participants may become upset

ü Identify coping mechanisms

ü Develop means to reduce stress and write an action plan for stress-relief

Part 5:Part 5: Intervention and Intervention and SelfSelf--Care for Care for FacilitatorsFacilitators

Part 5: Crisis Intervention and Self-Care

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Intervention

Program facilitators play a very important role in this study. You will be speaking directly with individuals and sometimes these individuals may come to you with personal problems. It is important that you provide participants with information and resources about how to seek help from professional service providers.

What Can I Do?

These are things you can do if someone in your group asks you for help or more information:

• Provide participants with individual or organization names and contact information, if you have it.

• If you don’t, let the participant know that you will look for resources for them and follow up. If you cannot find resources on your own, please contact the program coordinator.

• Show your interest and support. • Remember, you are not a therapists, so if participants are upset

they should be referred to therapists.

What if my Participant Gets Extremely Upset?

We have a protocol that must be followed if a participant becomes too emotional to continue the session. Although this is rare, it is good to be educated on what you should do if the situation arises.

1. Ask the participant if he or she would like to stop the session. If she says no but you believe she is too upset to continue, stop the session anyway. You are in control of the program. Reassure the family that they will still receive the token of appreciation, if that is a concern.

2. If the upset participant is the youth, inform any family members of the incident and make sure you document what happened for our files.

3. If the participant does not want immediate assistance but indicates that he/she is currently suicidal, you must notify the proper authorities.

Dealing with a crisis situation is difficult. If you encounter any of these situations, notify your supervisor immediately and document the situation for UNL Staff.


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Self-Care for Facilitators5

Common Sources of Facilitator Stress

• Time pressures • Long hours • Witnessing numerous crisis reactions • Pushing self too hard • Inability to set appropriate boundaries • Relationship to the participant

The emotions experienced by the facilitator are real, often strong, and must be dealt with constructively. This is one of the most challenging aspects of working with trauma survivors, and often professional training does not provide enough preparation for handling one’s own emotional reactions to the traumatic stories. The need to understand, contain and even transform these reactions makes the task of working with trauma survivors both very rewarding and difficult.

Physical Reactions

• Fatigue • Loss of appetite • Difficulty falling

asleep • Restlessness • Headaches • Changes in eating

habits • Increased

susceptibility to illnesses

• Changes in alcohol and drug consumption

Emotional Reactions

• Increased mood swings

• Decreased motivation

• Feeling burned out • Crying

frequently/easily • Isolation • Feeling helpless • Feeling overwhelmed • Feeling inadequate • Feeling fragile • Feeling vulnerable • Feeling unable to

cope

Cognitive Reactions

• Confusion • Difficulty making

decisions • Difficulty solving

problems • Memory blanks • Questioning why this

happened in a world that is supposed to be safe

• Having ambiguous feelings

• Difficulty concentrating or paying attention

One of the most difficult challenges for facilitators is to maintain some kind of balance between the demands of the project and the needs of their own self and families. Keep the lines of communication open and visit with your colleagues and supervisor often, sharing both positive and negative experiences. Know what resources are available for you and your family should you need additional care.

5 This section was taken or adapted from the International Society for Traumatic Stress Studies, http://www.istss.org/Home.htm


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Stress Reducing Activities

• Go for a walk • Eat sensibly • Know and respect your limits • Spend time with family and friends • Get some rest • Share your own and participants’ reactions with colleagues • Be self-nurturing

Debrief with your supervisor as soon after a crisis situation has been handled

Every research worker has the responsibility to protect the rights and welfare of research subjects who are participating in their research. This training is designed specifically to aid you in understanding the importance and implications of research at the University Level. The human subjects who are participating in the research process are the first and most important part of the research.


ü Understand the development of ethics regulations

ü Give examples of poor studies regarding human subjects

ü Describe the three principles of research

ü Explain informed consent

Part 6:Part 6: Human SubjectHuman Subjects s TrainingTraining

Part 6: Human Subjects Training

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Ethics of Working with Human Subjects6

Human subjects are those people who agree to participate in your research project. Any research that involves getting information directly from people (e.g., asking interview questions, mailing questionnaires, conducting focus groups) or about people indirectly (e.g., observing behaviors, gathering information from records) is included as part of human subject research.

All research involving human subjects must be assessed to ensure adequate protections. You will be learning about what protections are important in this training. It is hard to believe, but 50 years ago there were no formal and uniform regulations protecting research participants from harm and deception. Today we have many regulations to protect subjects’ mental, physical, and emotional well-being.

The Development of Ethics Rules

Let’s look at historical events that contributed to formulation of research regulations:

• 1947: Twenty-six Nazi physicians were tried at Nuremberg, Germany, for research atrocities performed on prisoners of war. This resulted in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal (a prototype for later codes of ethics). The basic elements of the Nuremberg Code are the requirement for voluntary and informed consent, favorable risk/benefit analysis, and the right to withdraw without penalty.

• 1955: Social science researchers at the University of Chicago conducted a study of jury decision-making processes. The study involved audio taping jury deliberations. To avoid influencing jurors, they were not told they were being studied. There was strong public reaction. The basic concern was that deception was used in a setting where privacy and confidentiality were critically important. Congressional hearings were held and a federal law was passed barring any future recording of jury deliberations. This was the first time that well intentioned research resulted in establishment of federal guidelines to protect the public. It focused attention on how, in some settings, important research questions cannot be answered without compromising the integrity of important social institutions.

• 1962: Thalidomide is a drug that was used in the 1950’s to treat

6 This section was taken or adapted from rom the Claremont Graduate University webpage http://ohsr.od.nih.gov/guidelines/belmont.html


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a variety of unpleasant symptoms associated with pregnancy. At the time that thalidomide was being used in the US, it was not standard practice to inform patients of the investigational nature of medications that were still in the testing phase of the regulatory practice. After a large number of pregnant women were treated with thalidomide, it became clear that this drug caused severe growth deformities in their infants. Public outrage led to an amendment to the Food, Drug, and Cosmetic Act, (The Kefauver-Harris Bill). This legislation was passed to ensure greater drug safety in the United States.

• 1964: The World Medical Association met in Helsinki, Finland, and issued recommendations to guide physicians in biomedical research involving human subjects. The declaration reinforced the principles of the Nuremberg Code and added two key points: 1) That the interest of the subject is higher priority than society and 2) that every subject should get the best known treatment.

Congressional Hearings of 1973

In 1973 special congressional hearings were called to look into human subjects concerns. Let’s look briefly at some of the studies that raised concerns.

1950’s - WillowBrook Hepatitis Study: In the 1950’s a series of studies were done to understand issues related to the transmission of the hepatitis virus in mentally retarded children who were residents in the Willowbrook state school in New York. The aspect of this research that generated debate in both the national media and professional journals was a study design that involved intentionally infecting healthy children with hepatitis by feeding them a solution made from the feces of children with active hepatitis.

1960’s - Chronic Disease Hospital Study: In the 1960’s a series of experiments were performed on chronically ill, mostly demented patients in the Jewish Chronic Disease Hospital in New York City. All of the subjects had illnesses that compromised their immune system. The purpose of the research was to determine how a weakened immune system influenced the spread of cancer. To evaluate this issue, live cancer cells were injected into the bloodstream of the subjects.

1960’s - The Milgram Studies of Obedience to Authority: Milgram's studies were designed in the aftermath of World War II when the world was trying to understand that acts of genocide that happened during the holocaust. The basic purpose of the Milgram Studies was to understand why people follow the directions of authority figures even when they are told to do things cruel and unethical. The experiment involved subjects who were deceived into thinking that they were helping with a study to evaluate the role of negative reinforcement on


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learning. The subjects were instructed to deliver an electric shock when the person playing the role of the learner answered incorrectly. As the study progressed, people were asked to give progressively stronger punishment shocks. More than half of the subjects eventually delivered what they thought were high-intensity, potentially lethal shocks in spite of expressions of serious distress on the part of the person who was playing the role of the “learner.” After completion of the study, the subjects were debriefed about the true purpose of the study, and many experienced extreme psychological distress after understanding the level of cruelty of their actions.

1970s - Contraception Study: In the early 1970’s a study was conducted in a contraception clinic in San Antonio, Texas to evaluate the efficacy of different kinds of contraception pills. The clinic served predominantly indigent patients who had no other place to go for contraceptive advice and medication. The study involved randomizing subjects between active contraceptive pills and placebos. The women were not informed that they were the subjects of this type of research or that they might be receiving inactive medication. As expected, there were high numbers of unplanned pregnancies in the placebo group.

1970’s - The Tearoom Trade Study: In the early 1970’s social scientist Laud Humphreys conducted a study of homosexual behavior in public restrooms. Dr. Humphries was able to function as a watch queen outside public restrooms where people gathered to engage in anonymous homosexual activity. Humphries recorded license numbers and other identifying information from the people who came for these interactions and used this information to obtain names and addresses. He went to the homes of the study subjects and presented himself as an interviewer to collect information about their background and family life. Many of the subjects were living with their family in a situation where it would be devastating to reveal information about homosexual activity. At no time did the subject understand that they were participating in research. In published reports of the study the level of detail was such that the identity of some of the subjects became known.

1930’s to 1970’s - The Tuskegee Syphilis Study: Between 1932 and 1972, the US Public Health Service Funded a study to evaluate the natural history of untreated syphilis in human beings. When this study was initiated, its basic concept was considered scientifically important and ethically justifiable because there was no effective treatment for this devastating disease. In retrospect, the main problem with this research was that the subject population was one of the most vulnerable in our society – approximately 300, indigent, uneducated, African-American sharecroppers in Macon County in Alabama who were known to have syphilis.


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The subjects of the Tuskegee Study did not have a meaningful understanding of their condition or the nature of the research that was being conducted. Although deception may not have been intentional on the part of the investigators, the reality is that the subjects thought they were receiving beneficial medical care and did not understand that they were participating in research that was designed specifically to observe the course of their illness. Participants were subjected to various tests and procedures, such as spinal taps, that were done solely for research purposes. The subjects were followed without treatment for many years after penicillin became widely available and was known to beneficial in the treatment of syphilis.

The actions of the researchers in the Tuskegee Syphilis study also involved active responses to keep study participants from getting treatment from other sources. For example, the researchers arranged for the subjects to be exempted from the military draft during World War II, since induction into the military would have involved routine treatment by penicillin for the syphilis. Also, study participants were informed that they would lose one of the primary benefits of the study, a paid burial, if they volunteered for military duty. The study provided many examples of the need for implementing a more formal and uniform system of human subjects provisions. The study was stopped in 1972 after high-profile stories in the national media generated public outrage over the blatant exploitation of the research subjects.

National Research Act of 19747

The National Research Act of 1974 established the modern Institutional Review Board (IRB) system for regulating research involving human subjects. The act passed federal regulations that require IRB approval to conduct most kinds of research involving human subjects, defined the policy and procedures that an IRB must follow when reviewing research, and established the criteria that an IRB must use to approve research conduct.

The National Research Act of 1974 established the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research made up of a diverse group of individuals representing fields of ethics, religion, law, industry, medicine, and other disciplines.

Amendments to the Act

In 1978 the National Commission released the Belmont Report that detailed the fundamental ethical principles that should guide human subject’s research. In 1981 the Department of Health and Human 7 This section was taken or adapted from Zimmerman, Janet F. 1997. “The Belmont Report: An Ethical Framework for Protecting Research Subjects.” http://www.impactcg.com/docs/BelmontReport.pdf


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Services established IRB regulations (45 CFR 46) that are now common to most federal agencies and have become known as the “common rule.”

The Belmont Report8

The Belmont Report of 1979 is an eight-page document that clearly explains the three principles that are the main tools that all IRB members should use to evaluate the ethics of specific research proposals.

Basic Principal #1: Respect for Persons

The first main rule is that people should not be coerced into participating in research. Coercion means that a person is to some degree forced or at least strongly pushed to do something that is not good for him or her to do. In discussions of research regulation the term “undue influence” is often used to describe the concept of coercion.

Coercion is unethical because individuals who are coerced into participating in research have diminished autonomy to the degree that the principle of respect for persons demands. Autonomy demands that a person be in control of his/her own life and not suffer from diminished self-worth and independence after participating in the research project.

Ways to reduce coercion include explaining to subjects: • The purpose of the research • Procedures involved • Potential risks and benefits • Alternatives to participation • Participation is voluntary • May withdraw at any time • Time to process the information

To ensure that participants are informed and accept their role as subjects, they must sign an informed consent. Obtaining a signature on a consent document is important, but it is just one step in the continuous process of informed consent. Informed consent is about people's understanding and willingness to participate in your study—it is not just about signing a form. Prospective participants in your research study must understand the purpose, the procedures, the potential risks and benefits of their involvement, and their alternatives to participation. While a consent document that gives

8 This section was taken or adapted from The Belmont Report (Office of Human Subjects Research) http://ohsr.od.nih.gov/guidelines/belmont.html and Institutional Review Board: Management and Function (Amdur & Bankert, 2006) and The University of Minnesota: Informed Consent Overview webpage http://www.research.umn.edu/consent/


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this information, and more, is a vital part of the process, the opportunity to discuss any questions or concerns with a knowledgeable research team member is also necessary. In addition, prospective participants may need time to think about their decision and to discuss it -- if necessary -- with family, friends, or religious advisors. Making an informed decision about participating in research includes having an understanding of the possible risks and benefits of their involvement, and knowing absolutely that they do not have to volunteer and can withdraw at any time.

Autonomy means that people should be given the respect, time, and opportunity necessary to make their own decisions. Prospective participants must be given the information they will need to decide to enter a study or not to participate. There should not be pressure to participate. The principle of autonomy requires that protection be given to potentially vulnerable populations such as children, the elderly, the mentally ill, or prisoners. Individuals in these groups may be incapable of understanding information that would enable them to make an informed decision about study participation. They are considered potentially "vulnerable." Consequently, careful consideration of their situation and needs is required and extra care must be taken to protect them.

The second main rule is that people with diminished autonomy are entitled to protection to prevent exploitation.

Some examples of potentially vulnerable subjects: • Children and young persons who have not reached the age of

majority • Persons with mental impairments • Have low socio-economic status • Are elderly • Have similar histories which raise concern

The third main rule is that researchers will respect a person’s privacy and confidentiality. The protection of privacy and confidentiality is a concept that follows directly from the principle of respect for persons. The harm that results from invasion of privacy or breach of confidentiality is usually called social harm because it compromises a person’s reputation, financial status, employability or insurability, or in some way results in stagnation or discrimination.

• Privacy: sensitive research information will not be linked to specific individuals

• Confidentiality: sensitive, identifiable information is collected for research purposes but access to the information is limited to a well-defined group (research team & IRB).


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Basic Principal #2: Beneficence

Beneficence obligates the researcher to secure the well-being of all study participants. It is your responsibility to protect participants from harm, as well as ensure that they experience the possible benefits of involvement. Balancing risks and benefits is an important consideration. The key, according to the 1979 Belmont Report on the protection of human subjects, is to "maximize possible benefits and minimize possible harms."

When do the benefits to society outweigh the possible risks of research? This is an ethical question that researchers face. The peer review process and the principle of beneficence help you answer this question and protect your research participants’ rights.

Basic Principal #3: Justice

The ethical considerations of risks versus benefits raise the question of justice. Who should bear the risk of a study and who should receive its benefits? The concept of justice may be questioned when we attempt to decide who will be given an opportunity to participate and who (and for what reason) will be excluded. Are some classes or persons being selected simply because of their availability, compromised position, or their manipulability while others are not?

Keep the following tips in mind when selecting prospective participants:

• Participants should not be selected due to class, socioeconomic status, or race unless justified by study objectives.

• Women have been underrepresented in certain research studies because of the risks associated with child-bearing. Now researchers must justify why women are not included in a study population.

• An existing counselor-client relationship requires consideration of the potential for power-based coercion when expanding that relationship to include investigator-subject.

• Teacher-student relationships always carry a perception of inequality in roles. The informed consent process should reflect the precautions taken to balance the relationship and guard against even the perception of coercion.

Justice is a difficult and complex ethical issue. Attempt at all times to distribute risks and benefits fairly and without bias.

Protecting Human Subjects9

The Institutional Review Board (IRB) is the cornerstone of an institution's program for the protection of human subjects. IRB’s are 9 This section was taken or adapted from the IRB Office at the University of Nebraska-Lincoln, http://research.unl.edu/orr/irbatunl.shtml


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responsible for ensuring that an institution meets the requirements of the Federal regulations, and that the rights and welfare of the subjects are adequately protected.

Responsibilities of the IRB

The IRB reviews, and has the authority to approve, require modification in, or disapprove all research activities, including proposed changes in ongoing, previously approved, human subject research. It may also suspend or terminate the approval of ongoing, previously approved research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected, serious harm to subjects.

After IRB approval is obtained, the next important step is training research workers to understand their role as a research worker.

Responsibilities of the Research Worker

Research involving human subjects in the social and behavioral sciences poses complex ethical issues. It requires careful thought and consideration on the part of both researchers and research participants. Prospective participants must be given adequate information on both the possible risks and the potential benefits of their involvement to allow them to make informed decisions. It is your responsibility to educate the participants about risks and benefits, obtain their consent before involving them in your research, and keep them informed. This is the "informed consent process."

A research worker must understand the following: • Consent form must be signed by the participant • Participant must be given a copy. • Consent forms are kept in the investigator’s file for reference.

Human Subjects Protocol

Once you have obtained consent, you may proceed with the research. Be sure to follow human subject’s protocol:

• Answer any questions the respondent might have during the process.

• Permit the respondent to skip questions if requested. • Discontinue the questions if the respondent indicates he/she

wants to stop. • Maintain confidentiality and do not discuss participant’s

information with others.

Adverse Events

The unfolding of adverse events is a serious and important development. Adverse events are unexpected problems whose nature,


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severity, or frequencies are not described accurately in the study protocol. It is the researcher’s responsibility to analyze the impact of an adverse event. Is this an isolated event or is it more common? Does this event have severe consequences or is the outcome unaffected? What is the appropriate ethical action to be taken? Incidents where subjects have been seriously harmed should be reported immediately.

• Notify the Coordinator:

• Notify the Project coordinator: Dominique Geoffroy (514-340-8222 ext. 2192) [email protected] Fax: 514-340-7503

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