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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist youth with emotional and behavioral issues, such as anxiety, depression, and stress, particularly in families resettled in the U.S. as refugees. The RRF4H Combination Intervention merges family group discussions with a virtual peer mentoring program, where teens learn to manage stress, avoid trouble, and improve communication. Researchers will compare this new approach to usual care to determine its effectiveness. Suitable participants include teens born in the U.S., attending high school (grades 9-12), and residing in the Omaha or Lincoln, NE area. As an unphased trial, this study provides a unique opportunity for teens to contribute to innovative solutions for emotional and behavioral challenges.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this combination intervention is safe for addressing emotional and behavioral problems?

Research shows that the RRF4H Combination Intervention, which includes family support through group activities and an online peer mentoring program, is safe and easy to manage. In past studies on similar programs, participants generally experienced positive results with few negative effects.

The RRF4H approach focuses on improving communication, building relationships, and managing stress. These gentle methods aim to boost emotional and behavioral health without involving medication or medical procedures, which typically means fewer safety concerns. The online mentoring program, TeenAge Health Consultants, provides a safe and supportive space for young people to learn and grow without significant risk.

Overall, while specific data from this combination intervention are not yet available, previous research has shown the program's components to be safe. Participants usually see improvements in mental health without notable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The RRF4H Combination Intervention is unique because it blends a Multi-Family Group (MFG)-based Family Support model with a peer-mentoring program, aiming to tackle emotional and behavioral issues in a more holistic way. Unlike traditional counseling that primarily focuses on individual therapy, this approach emphasizes improving family communication and building supportive social networks, which can be crucial for managing stress and reducing stigma. Additionally, by utilizing a virtual platform for the TeenAge Health Consultants peer-mentoring program, the intervention offers greater accessibility and adaptability for participants. Researchers are excited about this trial because it could provide a more comprehensive and accessible support system for youth, potentially leading to better long-term outcomes.

What evidence suggests that the RRF4H Combination Intervention is effective for emotional and behavioral problems?

Research has shown that family strengthening programs can improve emotional and behavioral issues in children from refugee families. These programs emphasize better communication and building strong support networks, which help manage stress and reduce stigma. In this trial, participants in the RRF4H Combination Intervention Group will receive both these family strengthening programs and the TeenAge Health Consultants (Virtual TAHC) peer mentoring program. This program teaches young people how to handle conflict, stay out of trouble, and manage stress. Early findings suggest that using both approaches together could help with anxiety, depression, and PTSD (post-traumatic stress disorder) in refugee youth. Overall, evidence supports that this combined approach could improve mental health. ^{1 2 6 7 8}

Who Is on the Research Team?

Nhial T Tutlam, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/rrf4h-combination-intervention-for-emotional-and-behavioral-problems-c57e1

RRF4H Combination Intervention for Emotional and ... The goal of this type I hybrid effectiveness-implementation trial is to test a family strengthening (FS) model delivered through multiple family groups ...

2. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/15/10/e108824/DC1/embed/inline-supplementary-material-1.pdf?download=true

Resettled Refugee Families for Healing (RRF4H) resolve them can improve emotional and behavioral problems among children from refugee families resettled in the United States. WHAT WILL HAPPEN DURING THIS ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06176638?keyword=%22Aggressive%20Behavior%22

San Mateo Clinical Trial Resettled Refugee Families for Healing This is a type 1hybrid effectiveness-implementation trial to test a combination intervention designed to improve intergenerational trauma-related mental ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12542554/

Resettled Refugee Families for Healing (RRF4H) study protocol This study aims to adapt and test an intervention addressing intergenerational trauma-related emotional and behavioural health outcomes among US ...

5. reporter.nih.gov reporter.nih.gov/project-details/11121014

Resettled Refugee Families for Healing (RRF4H ... - NIH RePORTER Studies have found that refugee youth living in high income countries have high prevalence of trauma-associated mental disorders like PTSD, (19% to 54%) and ...

6. withpower.com withpower.com/clinical-trials/for-anxiety-disorder

Top Anxiety Disorder Clinical Trials | Power RRF4H Combination Intervention for Emotional and Behavioral Problems. Omaha ... Phase 1 trials are the trials to collect safety data in humans. Phase 2 ...

7. reporter.nih.gov reporter.nih.gov/project-details/9568363

Project Details - NIH RePORTER This study asks whether children who benefit from early interventions grow up to become better parents and, subsequently, have children who experience fewer ...

8. researchgate.net researchgate.net/publication/325587020_Suubi4Her_A_study_protocol_to_examine_the_impact_and_cost_associated_with_a_combination_intervention_to_prevent_HIV_risk_behavior_and_improve_mental_health_functioning_among_adolescent_girls_in_Uganda

(PDF) Suubi4Her: A study protocol to examine the impact ... Suubi4Her: A study protocol to examine the impact and cost associated with a combination intervention to prevent HIV risk behavior and improve ...