Resettled Refugee Families for Healing

Depression Clinical Trial

— RRF4H  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06176638
• Other study ID #: 202307081
• Secondary ID: 1K01MH131872-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Nhial T Tutlam, PhD
• Phone: 314-935-3714
• Email: ntutlam[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 308
• Est. completion date: June 30, 2027
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aggression
• Aggressive Behavior
• Antisocial Personality Disorder
• Anxiety
• Depression
• Personality Disorders
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• RRF4H Combination Intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

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* Note: There are 70 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Feasibility	Intervention feasibility will be measured using Recruitment rates; proportion eligible and enrolled (=70% enrollment considered feasible)	Baseline, 16 Weeks post-intervention, and 6 months
Other	Intervention Acceptability	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/	6 months post-intervention
Primary	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).	Baseline, 16 Weeks post-intervention, and 6 months
Primary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Primary	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).	Baseline, 16 Weeks post-intervention, and 6 months
Primary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Primary	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)	Baseline, 16 Weeks post-intervention, and 6 months
Primary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Primary	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).	Baseline, 16 Weeks post-intervention, and 6 months
Primary	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).	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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).	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	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.	Baseline, 16 Weeks post-intervention, and 6 months
Secondary	Change in Risk-taking Behaviors	Change in Risk-Taking Behaviors will be assessed using the Youth Risk Behavior Survey.	Baseline, 16 Weeks post-intervention, and 6 months