RRF4H Combination Intervention for Emotional and Behavioral Problems

(RRF4H Trial)

Overseen By Nhial T Tutlam, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Emergency needs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

Duration: 16 weeks

308 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nhial T Tutlam, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for families where parents were resettled as refugees in the U.S. and have a child born in the U.S., aged 14-17, enrolled in Omaha or Lincoln, NE area schools. Parents must be over 30 years old. Peer mentors are upperclassmen nominated by community leaders.

Inclusion Criteria

I am a refugee in the U.S., over 30, and have a child aged 14-17.

My child is 14-17, in grades 9-12, and goes to school in Omaha or Lincoln, NE.

I am an 11th or 12th grader nominated to be a mentor.

Exclusion Criteria

Can understand the study procedures and/or participant rights during the informed consent process

I am willing and able to complete the study.

Present with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Family strengthening intervention delivered through multiple family groups (MFG) and a peer mentorship program called TeenAge Health Consultants (TAHC) over 16 weeks

16 weeks

16 weekly group sessions (in-person) and 16 weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 16 weeks and 6 months post-intervention

Treatment Details

Interventions

• RRF4H Combination Intervention

Trial Overview The study tests a family strengthening model through group sessions and a virtual peer mentoring program aimed at reducing emotional and behavioral issues like aggression, anxiety, depression, and PTSD among refugee children.

Participant Groups

Group I: RRF4H Combination Intervention Group Experimental Treatment 1 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.

Group II: Usual Care Group Active Control 1 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+