Resettled Refugee Families for Healing (RRF4H)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Stress Disorders, Post-Traumatic; Anxiety; Antisocial Personality Disorder; Aggressive Behavior
• Intervention / Treatment: Behavioral: RRF4H Combination Intervention

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).

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68111
      • Nile Lutheran Church

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RRF4H Combination Intervention Group; 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; 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.; Other Names: Virtual TeenAge Health Consultants (TAHC)
No Intervention: Usual Care Group; 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?

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 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
Improvement in Family and Social Support	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.	Baseline, 16 Weeks post-intervention, and 6 months
Change 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Feasibility	Intervention feasibility will be measured using Recruitment rates; proportion eligible and enrolled (≥70% enrollment considered feasible)	Baseline, 16 Weeks post-intervention, and 6 months
Intervention Acceptability	Intervention acceptability will be assessed using Client Satisfaction Questionnaire (CSQ-8; to be adapted). Scores range from 8 to 32 with higher score indicating higher degree of satisfaction/acceptability/	6 months post-intervention

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Nhial T Tutlam, PhD, Washington University School of Medicine

Publications and helpful links

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Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Resettled Refugee Youth; Intergenerational Transmission of Trauma; Multiple Family Groups; TeenAge Health Consultants; Trauma-Associated Mental Disorders
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Aberrant Motor Behavior in Dementia; Mental Disorders; Behavioral Symptoms; Personality Disorders; Stress Disorders, Traumatic; Behavior; Social Behavior; Anxiety Disorders; Depression; Aggression; Stress Disorders, Post-Traumatic; Antisocial Personality Disorder
• Other Study ID Numbers: 202307081; 1K01MH131872-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the principal investigator (PI) intends to share the data and I will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented, as appropriate.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No