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Stress Disorders, Post-TraumaticRRF4HNCT06176638

Resettled Refugee Families for Healing

A study testing RRF4H Combination Intervention in people with Stress Disorders, Post-Traumatic and Depression, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 to 17 yearsHealthy volunteers can take part
What is being tested?
RRF4H Combination Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
1 siteUnited States
Study dates
1 Jun 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Nile Lutheran Church

    Omaha, Nebraska, 68111

Other trials in United States

About this study

Official title: 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).

Read more

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.

Read the 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).

Being tested
RRF4H Combination Intervention
Keywords
Resettled Refugee Youth, Intergenerational Transmission of Trauma, Multiple Family Groups, TeenAge Health Consultants, Trauma-Associated Mental Disorders
Medical subject headings
Stress Disorders, Post-Traumatic, Depression, Antisocial Personality Disorder, Anxiety Disorders, Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RRF4H Combination InterventionBehavioural

    Also called Virtual TeenAge Health Consultants (TAHC)

    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.

Study groups in NCT06176638
Study groupRoleWhat they receive
RRF4H Combination Intervention GroupExperimentalThis 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.
Receives: Behavioral: RRF4H Combination Intervention
Usual Care GroupNo interventionYouth 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  2. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  3. 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).

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  4. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  5. 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)

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  6. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  7. 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).

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  8. 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).

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

Secondary outcomes (14)

  1. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  2. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  3. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  4. 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).

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  5. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  6. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  7. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  8. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  9. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  10. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  11. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  12. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  13. 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.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

  14. Change in Risk-taking Behaviors

    Change in Risk-Taking Behaviors will be assessed using the Youth Risk Behavior Survey.

    Measured: Baseline, 16 Weeks post-intervention, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2023
  2. Study start1 Jun 2024
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
308 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06176638
Sponsor's protocol ID
202307081
Other IDs
1K01MH131872-01A1
Acronym
RRF4H
Status last verified
Apr 2026
First submitted
1 Nov 2023
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Bronstein I, Montgomery P. Psychological distress in refugee children: a systematic review. Clin Child Fam Psychol Rev. 2011 Mar;14(1):44-56. doi: 10.1007/s10567-010-0081-0.

    PubMed 21181268

  • Jany L. Growing opioid use in Somali community spurs need for culturally relevant treatment. StarTribune2021

  • McCleary JS, Shannon PJ, Cook TL. Connecting Refugees to Substance Use Treatment: A Qualitative Study. Soc Work Public Health. 2016;31(1):1-8. doi: 10.1080/19371918.2015.1087906. Epub 2015 Dec 14.

    PubMed 26667046

  • Gundel BE. Sudanese refugees' psychological need and mental health care: A phenomenological study of Sudanese beliefs about psychological treatment. The University of Nebraska-Lincoln; 2016

  • Tutlam NT. The Impact of Maternal War Trauma on Children: A Study of South Sudanese Families Resettled in the US, Saint Louis University; 2017

  • Ensor MO. South Sudanese diaspora children: Contested notions of childhood, uprootedness, and belonging among young refugees in the US. In: Contested childhoods: Growing up in migrancy. Springer, Cham; 2016:61-77.

  • Kroll J, Yusuf AI, Fujiwara K. Psychoses, PTSD, and depression in Somali refugees in Minnesota. Soc Psychiatry Psychiatr Epidemiol. 2011 Jun;46(6):481-93. doi: 10.1007/s00127-010-0216-0. Epub 2010 Mar 31.

    PubMed 20354676

  • Minnesota State Epidemiological Outcomes Workgroup. Epidemiological Profile of Substance Use +Related Factors among Minnesota's Somali Youth. In: Minnesota Schools ea, ed. Saint Paul2017.

  • Abur W. Settlement strategies for the South Sudanese community in Melbourne: an analysis of employment and sport participation. Melbourne: Victoria University. 2018.

  • Sowey H. Are refugees at increased risk of substance misuse. Sydney: Drug and Alcohol Multicultural Education Centre. 2005

  • Spencer JH, Le TN. Parent refugee status, immigration stressors, and Southeast Asian youth violence. J Immigr Minor Health. 2006 Oct;8(4):359-68. doi: 10.1007/s10903-006-9006-x.

    PubMed 16841183

  • Buchanan RL, Smokowski PR. Pathways from acculturation stress to substance use among latino adolescents. Subst Use Misuse. 2009;44(5):740-62. doi: 10.1080/10826080802544216.

    PubMed 19308866

  • Reid CA, Lorraine Beyer, Nick Crofts, Gary. Ethnic communities' vulnerability to involvement with illicit drugs. Drugs: education, prevention and policy. 2001;8(4):359-374.

  • Poppitt G, Frey R. Sudanese adolescent refugees: Acculturation and acculturative stress. Journal of Psychologists and Counsellors in Schools. 2007;17(2):160-181.

  • Milner K, Khawaja NG. Sudanese refugees in Australia: The impact of acculturation stress. Journal of Pacific Rim Psychology. 2010;4(1):19-29

Questions about this trial

What is this clinical trial studying?

A study testing RRF4H Combination Intervention in people with Stress Disorders, Post-Traumatic and Depression, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adolescents (time frame: Baseline, 16 Weeks post-intervention, and 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06176638, which also lists 71 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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