Clinical trial NCT06176638: Resettled Refugee Families for Healing
Official title: Resettled Refugee Families for Healing (RRF4H): A Study of Intergenerational Impact of War Trauma and Resilience
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Depression
Antisocial Personality Disorder
Anxiety
Aggressive Behavior
Keywords: Resettled Refugee Youth
Intergenerational Transmission of Trauma
Multiple Family Groups
TeenAge Health Consultants
Trauma-Associated Mental Disorders
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-12-20
Enrollment: 308
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adolescents
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adults
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Depression Symptoms among adults
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Depression Symptoms among adolescents
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Anxiety Symptoms among adults
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Anxiety Symptoms among adolescents
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvements in Antisocial Behavior Symptoms (adolescents only)
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Aggressive Behavior Symptoms (adolescents only)
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
Secondary outcomes:
measure: Improvement in Family Cohesion
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Social Social Support
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Family and Social Support
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Family Communication
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Family Functioning
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Mental Health Stigma
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Self-Concept
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Self-efficacy
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improvement in Hopelessness
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improved peer support/relationships
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Improved prosocial attitudes/conduct problems
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Exposure to Potentially Traumatic Events (PTE)
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Exposure to Adverse Childhood Experiences (ACEs)
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Change in Risk-taking Behaviors
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
Other outcomes:
measure: Intervention Feasibility
timeFrame: Baseline, 16 Weeks post-intervention, and 6 months
measure: Intervention Acceptability
timeFrame: 6 months post-intervention
Locations:
city: Omaha
country: United States
facility: Nile Lutheran Church
state: Nebraska
Study officials:
affiliation: Washington University School of Medicine
name: Nhial T Tutlam, PhD
role: PRINCIPAL_INVESTIGATOR
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