Resettled Refugee Families for Healing (RRF4H): A Study of Intergenerational Impact of War Trauma and Resilience
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 308
- 试验地点
- 2
- 主要终点
- Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adolescents
研究概览
简要总结
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:
- 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.
- 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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
RRF4H Combination Intervention Group
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.
干预措施: RRF4H Combination Intervention (Behavioral)
Usual Care Group
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.
结局指标
主要结局
Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adolescents
时间窗: 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).
Improvements in Antisocial Behavior Symptoms (adolescents only)
时间窗: 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).
Improvement in Aggressive Behavior Symptoms (adolescents only)
时间窗: 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).
Improvement in Post-Traumatic Stress Disorder (PTSD) Symptoms among adults
时间窗: 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.
Improvement in Depression Symptoms among adults
时间窗: 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).
Improvement in Depression Symptoms among adolescents
时间窗: 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.
Improvement in Anxiety Symptoms among adolescents
时间窗: 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.
Improvement in Anxiety Symptoms among adults
时间窗: 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)
次要结局
- Mental Health Stigma(Baseline, 16 Weeks post-intervention, and 6 months)
- Improvement in Self-efficacy(Baseline, 16 Weeks post-intervention, and 6 months)
- Improvement in Hopelessness(Baseline, 16 Weeks post-intervention, and 6 months)
- Improvement in Family Cohesion(Baseline, 16 Weeks post-intervention, and 6 months)
- Improvement in Social Social Support(Baseline, 16 Weeks post-intervention, and 6 months)
- Improvement in Family and Social Support(Baseline, 16 Weeks post-intervention, and 6 months)
- Improvement in Family Communication(Baseline, 16 Weeks post-intervention, and 6 months)
- Improvement in Family Functioning(Baseline, 16 Weeks post-intervention, and 6 months)
- Improvement in Self-Concept(Baseline, 16 Weeks post-intervention, and 6 months)
- Exposure to Potentially Traumatic Events (PTE)(Baseline, 16 Weeks post-intervention, and 6 months)
- Change in Risk-taking Behaviors(Baseline, 16 Weeks post-intervention, and 6 months)
- Improved peer support/relationships(Baseline, 16 Weeks post-intervention, and 6 months)
- Improved prosocial attitudes/conduct problems(Baseline, 16 Weeks post-intervention, and 6 months)
- Exposure to Adverse Childhood Experiences (ACEs)(Baseline, 16 Weeks post-intervention, and 6 months)
研究者
Nhial Timothy Tutlam, PhD
Assistant Professor
Washington University School of Medicine