Resettled Refugee Families for Healing
- Conditions
- DepressionAntisocial Personality DisorderStress Disorders, Post-TraumaticAggressive BehaviorAnxiety
- Interventions
- Behavioral: RRF4H Combination Intervention
- Registration Number
- NCT06176638
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
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 Posttraumatic Stress Disorder \[PTSD\]) 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:
1. 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.
2. 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
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, Nebraska. 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 Posttraumatic Stress Disorder \[PTSD\]) 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 308
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RRF4H Combination Intervention Group RRF4H Combination Intervention 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.
- Primary Outcome Measures
Name Time Method Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adolescents Baseline, 16 Weeks post-intervention, and 6 months 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).
Improvements in Antisocial Behavior Symptoms (adolescents only) Baseline, 16 Weeks post-intervention, and 6 months 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).
Improvement in Aggressive Behavior Symptoms (adolescents only) Baseline, 16 Weeks post-intervention, and 6 months 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).
Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adults Baseline, 16 Weeks post-intervention, and 6 months 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.
Improvement in Depression Symptoms among adults Baseline, 16 Weeks post-intervention, and 6 months 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).
Improvement in Depression Symptoms among adolescents Baseline, 16 Weeks post-intervention, and 6 months 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.
Improvement in Anxiety Symptoms among adolescents Baseline, 16 Weeks post-intervention, and 6 months 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.
Improvement in Anxiety Symptoms among adults Baseline, 16 Weeks post-intervention, and 6 months 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)
- Secondary Outcome Measures
Name Time Method Mental Health Stigma Baseline, 16 Weeks post-intervention, and 6 months 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.
Improvement in Self-efficacy Baseline, 16 Weeks post-intervention, and 6 months 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.
Improvement in Hopelessness Baseline, 16 Weeks post-intervention, and 6 months Change in hopelessness will be measured using Beck Hopelessness Scale. Scores range from 20 to 40 with higher score indicating higher degree of hopelessness.
Improvement in Family Cohesion Baseline, 16 Weeks post-intervention, and 6 months 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.
Improvement in Social Social Support Baseline, 16 Weeks post-intervention, and 6 months 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.
Improvement in Family and Social Support Baseline, 16 Weeks post-intervention, and 6 months Change in family and social support will be assessed using University of California, Los Angeles (UCLA) Loneliness Scale, version 3. Scores range from 20 to 80 with higher score indicating higher loneliness.
Improvement in Family Communication Baseline, 16 Weeks post-intervention, and 6 months 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).
Improvement in Family Functioning Baseline, 16 Weeks post-intervention, and 6 months 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.
Improvement in Self-Concept Baseline, 16 Weeks post-intervention, and 6 months 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.
Exposure to Potentially Traumatic Events (PTE) Baseline, 16 Weeks post-intervention, and 6 months 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.
Change in Risk-taking Behaviors Baseline, 16 Weeks post-intervention, and 6 months Change in Risk-Taking Behaviors will be assessed using the Youth Risk Behavior Survey.
Improved peer support/relationships Baseline, 16 Weeks post-intervention, and 6 months 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.
Improved prosocial attitudes/conduct problems Baseline, 16 Weeks post-intervention, and 6 months 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.
Exposure to Adverse Childhood Experiences (ACEs) Baseline, 16 Weeks post-intervention, and 6 months 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.
Trial Locations
- Locations (1)
Nile Lutheran Church
🇺🇸Omaha, Nebraska, United States