Resettled Refugee Families for Healing

Study Overview
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Brief Summary
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The goal of this type I hybrid effectiveness-implementation trial is to test a family strengthening (FS) model delivered through multiple family groups (MFG) combined with a virtual peer mentoring program called TeenAge Health Consultants (Virtual TAHC) aimed at addressing emotional and behavioral problems among youth born in the U.S. to parents resettled as refugees. The specific aims of the study are: Aim 1: To systematically adapt an evidence-based family strengthening (FS) model delivered through multiple family groups (MFG) combined with a peer mentoring program (Virtual TAHC) (Goal 1). Aim 2: To assess preliminary short- and long-term impact of the combination intervention (MFG + Virtual TAHC) on behavioral emotional disorders (aggressive behavior, antisocial behaviors, anxiety, depression, and PTSD) related to intergenerational trauma among SGRC in the trial (Goal 2). Aim 3: Utilizing mixed methods and applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, examine implementation strategies, facilitators, and barriers of the RRF4H intervention (Goal 3). Participants will receive: Family strengthening intervention delivered through multiple family groups (MFG) where children and one of their biological parents will participate in 16 weekly group sessions to discuss common problems and how to address them. The youth in the intervention will participate in a peer mentorship program called TeenAge Health Consultants (TAHC) consisting of 16 weekly virtual sessions where they interact with other youth to learn about important topics including how to deal with conflict, stay out of trouble, deal with stress, avoid drugs and other topics. Researchers will compare the intervention group to a control group that will receive the usual care to see if the intervention group shows improvement in symptoms compared to the usual care group.

Detailed Description
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This is a type 1hybrid effectiveness-implementation trial to test a combination intervention designed to improve intergenerational trauma-related mental health symptoms among second generation refugee children (SGRC). Guided by Social Action and Family Systems theories, and applying them to the ITT framework, the proposed combination intervention consists of: family strengthening (FS) model delivered through multiple family groups (MFG) + peer mentoring program called TeenAge Health Consultants (TAHC) adapted for delivery in virtual environment (Virtual TAHC). The proposed study, titled Resettled Refugee Families for Healing (RRF4H): A Study of Intergenerational Impact of War Trauma and Resilience, will target refugee families resettled in Omaha and Lincoln, NE. Using a two-arm randomized controlled trial, the investigators plan to recruit 154 children (77 per study arm), ages 14 - 17 and at least one biological parent per youth from resettled refugee communities. The intervention will be implemented over 16 weeks, with assessments at baseline, 16 weeks, and 6 months follow-up. The intervention will have the following specific aims: (1) systematically adapt an evidence-based family strengthening (FS) model delivered through multiple family groups (MFG) combined with a peer mentoring program (Virtual TAHC) (Goal 1); (2) assess preliminary short- and long-term impact of the combination intervention (MFG + Virtual TAHC) on behavioral emotional disorders (aggressive behavior, antisocial behaviors, anxiety, depression, and PTSD) related to intergenerational trauma among SGRC in the trial (Goal 2); and (3) utilizing mixed methods and applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, examine implementation strategies, facilitators, and barriers of the RRF4H intervention (Goal 3).

Official Title
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Resettled Refugee Families for Healing (RRF4H): A Study of Intergenerational Impact of War Trauma and Resilience

Conditions
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Stress Disorders, Post-Traumatic, Depression, Antisocial Personality Disorder, Anxiety, Aggressive Behavior

Intervention / Treatment
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* Behavioral: RRF4H Combination Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Children: Child born in the US Ages 14-17 years In the 9th - 12th grades Enrolled in one of the schools in Omaha and Lincoln, NE area Schools Inclusion Criteria for Peer Mentors: Peer mentors must be students in upper class (11th or 12th grade) and Willing and able to serve as good role models Peer mentors must be nominated by community leaders Inclusion Criteria for Parents: Parents must be someone resettled in the U.S. as refugee and be a biological parent of a child between the ages 14-17 years Parents must be ≥30 years of age Exclusion Criteria for All Participants: Can understand the study procedures and/or participant rights during the informed consent process Unwilling or unable to commit to completing the study; 2) Present with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to one of two treatment conditions at the community level: 1) Usual Care; (2) Combination intervention consisting of: MFG + Virtual TAHC peer mentoring program. Community will be defined as geographically designated areas of Omaha, and the City of Lincoln, Nebraska. Youth in will receive the usual mental health counseling provided through their school counselors. Those in the combination intervention will receive 16 MFG sessions along with their biological parents and 16 virtual TAHC sessions with their peers (excluding parents).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RRF4H Combination Intervention Group<br>This is a combination intervention that builds on the Usual Care and will consist of (1) a MFG-based FS model, which targets issues such as communication, relationship, and social support network development to assist with parenting and stress management, and stigma reduction96 and (2) a peer-mentoring program called TeenAge Health Consultants (Virtual TAHC) adapted for delivery in virtual environment. | Behavioral: RRF4H Combination Intervention<br>* MFG: is a family strengthening model where children and their parents sit together in groups of 8 to 10 families to discuss important issues. MFG approach provides a social support mechanism and strengthens family relationships by allowing families to share common experiences as well as effective strategies for addressing difficult issues; and focuses on reducing stigma and normalizing common experiences. TAHC: This is a peer-led program that allows younger students to talk with peers about important issues that they face, gain role models, and identify positive social norms from older peers. It provides age-appropriate lessons and is delivered in a structured fashion. The curriculum consists of sixteen 50-minute lessons spread out over two academic years. Topics delivered in the curriculum include substance use, positive outlook on life, forming a positive self-concept, decision making and problem solving, coping with depression, bullying and social media.<br>* Other names: Virtual TeenAge Health Consultants (TAHC);|
| No Intervention: Usual Care Group<br>Youth in RRF4H study will receive the usual mental health counseling provided through their school counselors. There is no structured curriculum for the group counseling programs but are available to all students as needed. The Lincoln Public School District also provides additional resources on specific topics such as trauma, depression and anxiety in children and adolescents, and alcohol substance use in families and provide appropriate referrals for those in need. Additionally, through organizations such as the International Council for Refugees and Immigrants (ICRI), refugee youth 7 to 18 years of age can receive educational and social support programs, after-school STEM clubs and one-on-one peer mentoring. Through the New Life Family Alliance, in addition to after-school program, boys and girls basketball program, youth are connected to youth-serving agencies that can help them effectively and successfully develop and take advantage of opportunities available to them. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adolescents | Change in symptoms of post-traumatic stress disorder (PTSD) will be assessed using Posttraumatic Stress Disorder Reaction Index (PTSD-RI) for adolescents. PTSD scores will be dichotomized between meeting diagnostic criteria for PTSD (>=35) and not meeting diagnostic criteria for PTSD (<35). | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adults | Change in symptoms of post-traumatic stress disorder (PTSD) will be assessed using the Harvard Trauma Questionnaire (HTQ). PTSD score will be dichotomized between meeting diagnostic criteria for PTSD >=2.0 and not meeting diagnostic criteria for PTSD <2.0. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Depression Symptoms among adults | Changes in depression symptoms will be measured using the Hopkins symptoms checklist 25. Depression score will be dichotomized between meeting diagnostic criteria for depression (>=1.75) and not meeting diagnostic criteria for depression (<1.75). | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Depression Symptoms among adolescents | Changes in depression symptoms will be measured using Hopkins symptoms checklist 37. There is no set clinical cut-off level, but higher score indicates symptoms severity. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Anxiety Symptoms among adults | Changes in anxiety symptoms will be measured using Hopkins symptoms checklist 25. Anxiety score will be dichotomized between meeting diagnostic criteria for anxiety (>=1.75) and not meeting diagnostic criteria or anxiety (<1.75) | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Anxiety Symptoms among adolescents | Changes in depression symptoms will be measured using Hopkins symptoms checklist 37. There is no set clinical cut-off level, but higher score indicates symptoms severity. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvements in Antisocial Behavior Symptoms (adolescents only) | Changes in antisocial behavior will be assessed using the Child Behavior Checklist for ages 6 to 18 years. T-scores will be dichotomized between abnormal range (T-score >=69) and normal range (T-score <69). | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Aggressive Behavior Symptoms (adolescents only) | Changes in aggressive behavior will be assessed using the Child Behavior Checklist for ages 6 to 18 years. T-scores will be dichotomized between abnormal range (T-score >=69) and normal range (T-score <69). | Baseline, 16 Weeks post-intervention, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Family Cohesion | Change in family cohesion will be assessed using family cohesion scale. This is a 6-item scale with possible scores ranging from 6 to 30 and higher score indicates higher degree of family cohesion. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Social Social Support | Change in family and social support will be assessed using Multidimensional scale of perceived social support. Scores range from 12 to 84 with higher score indicating higher social support. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Family and Social Support | Change in family and social support will be assessed using UCLA Loneliness Scale, version 3. Scores range from 20 to 80 with higher score indicating higher loneliness. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Family Communication | Change in family communication will be assessed using Child-Adolescent Communication Scale. Two subscales: 1) degree of openness: with higher score indicating better communication (scores range from 10 to 40); and 2) extent of problems with higher score indicating more problems in parent-child communication (scores range from 10 to 50). | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Family Functioning | Change in family functioning will be assessed using six healthy general functioning items from the McMaster Family Assessment Device with possible scores ranging from 6 to 24 and lower score indicating healthy functioning. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Mental Health Stigma | Change in stigma symptoms will be assessed using the Paediatric Self-Stigmatization Scale. Scores range from 31 to 114 with higher score indicating high degree of stigmatization. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Self-Concept | Change in Self-Concept will be assessed using Tennessee Self-Concept Scale. This is a 20-item scale with scores ranging from 20 to 100 and higher score indicating higher self-concept. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Self-efficacy | Change in Self-Efficacy will be assessed using the General Self-Efficacy Scale, a 10-item scale with scores ranging from 10 to 40 and higher score indicating higher self-efficacy. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improvement in Hopelessness | Change in hopelessness will be measured using Beck Hopelessness Scale. Scores range from 20 to 40 with higher score indicating higher degree of hopelessness. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improved peer support/relationships | Change in peer support relationship will be assessed using Strengths and Difficulties Questionnaire (SDQ). Scores for this subscale range from 5 to 25 with higher score indicating higher degree of peer relationships. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Improved prosocial attitudes/conduct problems | Change in prosocial attitudes/conduct problems will be measured using the Strengths and Difficulties Questionnaire (SDQ). Scores for this subscale range from 5 to 25 with higher score indicating higher degree of peer relationships. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Exposure to Potentially Traumatic Events (PTE) | Number of traumatic events participants are exposed to will be measured using the UCLA posttraumatic stress disorder reaction index (PTSD-RI). Higher score indicates high number of traumatic events. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Exposure to Adverse Childhood Experiences (ACEs) | Number of Adverse Childhood Experiences (ACEs) will be measured using Adverse Childhood Experience (ACEs) scale. Possible scores range from 1 to 10 with high number indicating higher ACEs score. | Baseline, 16 Weeks post-intervention, and 6 months | 
| Reduction in Risk-taking Behaviors | Change in Risk-Taking Behaviors will be assessed using the Youth Risk Behavior Survey. | Baseline, 16 Weeks post-intervention, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resettled Refugee Youth, Intergenerational Transmission of Trauma, Multiple Family Groups, TeenAge Health Consultants, Trauma-Associated Mental Disorders