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NCT Number: NCT06176638

Resettled Refugee Families for Healing

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Stress Disorders, Post-Traumatic Aberrant Motor Behavior in Dementia Aggression Aggressive Behavior Antisocial Personality Disorder Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Personality Disorders Social Behavior Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nile Lutheran Church

Omaha, Nebraska, 68111, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RRF4H Combination Intervention

Behavioral

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)

Primary outcomes

  1. Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adolescents

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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).

  2. Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adults

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  3. Improvement in Depression Symptoms among adults

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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).

  4. Improvement in Depression Symptoms among adolescents

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  5. Improvement in Anxiety Symptoms among adults

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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)

  6. Improvement in Anxiety Symptoms among adolescents

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  7. Improvements in Antisocial Behavior Symptoms (adolescents only)

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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).

  8. Improvement in Aggressive Behavior Symptoms (adolescents only)

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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).

Secondary outcomes

  1. Improvement in Family Cohesion

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  2. Improvement in Social Social Support

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  3. Improvement in Family and Social Support

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  4. Improvement in Family Communication

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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).

  5. Improvement in Family Functioning

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  6. Mental Health Stigma

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  7. Improvement in Self-Concept

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  8. Improvement in Self-efficacy

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  9. Improvement in Hopelessness

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    Change in hopelessness will be measured using Beck Hopelessness Scale. Scores range from 20 to 40 with higher score indicating higher degree of hopelessness.

  10. Improved peer support/relationships

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  11. Improved prosocial attitudes/conduct problems

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  12. Exposure to Potentially Traumatic Events (PTE)

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  13. Exposure to Adverse Childhood Experiences (ACEs)

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    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.

  14. Change in Risk-taking Behaviors

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

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

Other outcomes

  1. Intervention Feasibility

    Time frame: Baseline, 16 Weeks post-intervention, and 6 months

    Intervention feasibility will be measured using Recruitment rates; proportion eligible and enrolled (≥70% enrollment considered feasible)

  2. Intervention Acceptability

    Time frame: 6 months post-intervention

    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/

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: RRF4H

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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