Resettled Refugee Families for Healing (RRF4H)

The Washington University

Status: Active, not recruiting

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

Treatments: Behavioral: RRF4H Combination Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06176638

1K01MH131872-01A1 (U.S. NIH Grant/Contract)

202307081

Details and patient eligibility

About

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.

Full 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).

Enrollment: 308 estimated patients

Sex: All

Ages: 14 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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308 participants in 2 patient groups

RRF4H Combination Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: RRF4H Combination Intervention

Usual Care Group

No Intervention group

Description:

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.