Resettled Refugee Families for Healing

NCT06176638 | Active Not Recruiting DMC

• 2 other identifiers: 2023070811K01MH131872-01A1
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

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

Keywords

Resettled Refugee Youth; Intergenerational Transmission of Trauma; Multiple Family Groups; TeenAge Health Consultants; Trauma-Associated Mental Disorders

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (14)

• Improvement in Family Cohesion

  Baseline, 16 Weeks post-intervention, and 6 months

• Improvement in Social Social Support

  Baseline, 16 Weeks post-intervention, and 6 months

• Improvement in Family and Social Support

  Baseline, 16 Weeks post-intervention, and 6 months

• Improvement in Family Communication

  Baseline, 16 Weeks post-intervention, and 6 months

• Improvement in Family Functioning

  Baseline, 16 Weeks post-intervention, and 6 months

Other Outcomes (2)

• Intervention Feasibility

  Baseline, 16 Weeks post-intervention, and 6 months

• Intervention Acceptability

  6 months post-intervention

Study Arms (2)

RRF4H Combination Intervention Group

EXPERIMENTAL

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

Usual Care Group

NO INTERVENTION

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.

Interventions

RRF4H Combination Intervention BEHAVIORAL

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.

Also known as: Virtual TeenAge Health Consultants (TAHC)

RRF4H Combination Intervention Group

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Nile Lutheran Church

Omaha, Nebraska, 68111, United States

Location

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Antisocial Personality Disorder; Anxiety Disorders; Aggression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personality Disorders; Aberrant Motor Behavior in Dementia; Social Behavior

Study Officials

• Nhial T Tutlam, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: December 20, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

US (1)