Strengthening Family Coping Resources Open Trials

University of Maryland, Baltimore1 个研究点分布在 1 个国家目标入组 500 人开始时间: 2006年2月最近更新: 2025年6月5日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Maryland, Baltimore
入组人数: 500
试验地点: 1
主要终点: McMaster Family Assessment Device (FAD) or General Functioning Scale (FAD 12)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of the National Institute on Drug Abuse's intervention development model by testing a new family, skills-based intervention involving pre-post evaluation of families participating in multi-family groups. The purpose of this study is to gather practice-based evidence on the effectiveness of the manualized treatment, on the dynamics involved in the group format, and on implementation fidelity and feasibility. Analyses will involve initial exploration of the following hypotheses: 1) Families will show a significant increase in the constructive use of family coping skills and in general family functioning. 2) The target child will show a reduction in trauma-related symptoms and behavior problems. 3) Parents will show significant reductions in traumatic stress and other symptoms of distress. 4) Families will engage and participate in the treatment. 5) Providers will implement SFCR with fidelity.

Other outcomes of interest are the process measures that will be collected to monitor participation in the groups, cultural sensitivity and acceptability, clinician competence, and intervention integrity.

详细描述

Strengthening Family Coping Resources (SFCR) is a manualized, trauma-focused, skills-based intervention that uses a multi-family group format. SFCR is designed for families living in traumatic contexts with the goal of reducing the symptoms of posttraumatic stress disorder (PTSD) and other trauma-related disorders in children and adult caregivers. Since most families living in traumatic contexts contend with on-going stressors and threats, SFCR is also designed to increase coping resources in children, adult caregivers, and in the family system to prevent relapse and re-exposure. SFCR provides trauma treatment within a family format. SFCR includes additional therapeutic strategies designed to improve the family's ability to cope with on-going stress and threats of re-exposure. Specifically, SFCR builds the coping resources necessary to help families boost their sense of safety, function with stability, regulate their emotions and behaviors, and improve communication about and understanding of the traumas they have experienced. The model includes family work on storytelling and narration, which builds to a family trauma narrative. SFCR is currently being implemented at University of Maryland Medical Center (UMMC), at sites that are part of the National Child Traumatic Stress Network (NCTSN), and at community agencies within the Baltimore Metro area and beyond.

Families will participate in a multifamily version of the intervention. Multiple groups of 5-6 families will be conducted with pre-post data collected in addition to information on the feasibility of the intervention. Prior to beginning each group, families will be assessed using a structured assessment. This assessment will be repeated at the end of group (all groups) and approximately one year following the completion of the group (for UMMC groups only).

One child in each family will be designated as the research subject. The target child will be chosen according to age, aged 1 through 17 years old, and referral for services. If more than one child in the family meet these criteria, the primary caregiver will be given the option of how many children s/he would like to be assessed for inclusion in the study. Data on the parents will only be collected from mothers or female caregivers. If no female caregiver is available, the primary caregiver will complete the assessments.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 1 Year 至 17 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•Children aged 1 through 17 years old at the time of recruitment
•Child and family exposed to multiple traumas
•a partial diagnosis of PTSD (15-week treatment version)
•currently in the custody of a caregiver who agrees to participate in the study.
•a stable caregiving system as defined by a recent history of stability and unlikely to change in the next 6 months.

排除标准

•Children will be excluded only if they have active suicide ideation, an imminent risk for re-exposure due to their living environment, active psychosis, severe mental retardation or brain injury
•Parent/caregiver has active psychosis or is a danger to self/others.