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临床试验/NCT00809315
NCT00809315已完成不适用

Intervention Development and Pilot for Foster Care Youth

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2002年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
152
试验地点
2
主要终点
Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources.

研究概览

简要总结

The purpose of this study is to develop, standardize and provide a preliminary test of a novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which consists of therapeutic skills groups and mentoring, will improve mental health, social, academic and behavioral functioning and reduce youths' initiation of, and participation in, problem behaviors.

详细描述

This R21 application for a 3-year exploratory/development grant for intervention research is designed to develop, standardize and provide a preliminary test of a novel intervention for children, ages 9-11, placed in out-of-home care. Children and adolescents with a history of maltreatment and subsequent placement in foster care are at risk for substantial mental health and behavioral problems of great public health significance. In the prior longitudinal work with children in foster care, the investigators have described the population, examined child welfare system impact, and identified modifiable psychosocial risk and protective factors. These pre-intervention activities, supported by the principal investigator's K01 award, have enabled the investigator to address important methodological issues that have hampered the development of intervention efforts targeting this high-risk population.

Based on this pre-intervention research, feedback from focus group participants, and a review of other efficacious programs for high-risk youth, the investigators propose to design an intervention for preadolescent youth in foster care consisting of three primary components: assessment and advocacy, mentoring, and therapeutic skills groups. The proposed R21 activities include developing the assessment battery and intervention protocol, manualizing the treatment, estimating recruitment and attrition rates, and conducting a small-scale randomized-controlled pilot study of the intervention. The goals of the intervention will be to improve mental health, social, academic and behavioral functioning and to reduce youths' initiation of, and participation in, problem behaviors. The investigators will conduct a preliminary examination of whether these proximal outcomes are moderated by baseline characteristics and/or mediated by the process variables targeted by the intervention. Estimates of effect size will be used to determine the sample size needed for adequate power to conduct a full-scale randomized controlled trial. The pilot study will also focus on issues of feasibility, program uptake, and replicability, and the investigators will modify the assessment battery, protocol, and manuals following the pilot phase and prior to the application for an R01 to conduct a large-scale efficacy trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
9 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All of the 9-11-year-old children court-ordered into out-of-home care (as a result of maltreatment) over the prior year in participating counties, including:
  • Youth placed in group homes, foster homes, and with kin
  • Youth with significant behavior problems
  • Youth who meet criteria for mental health diagnoses or dual diagnosis
  • Youth with mild cognitive impairment

排除标准

  • Youth who reunify before the beginning of the intervention
  • Youth with significant cognitive, behavioral, and/or mental health impairment that interfered with either with their ability to benefit from the prevention program or to participate safely
  • Youth who were not proficient enough in English to participate
  • Youth who lived too far from sites where groups were hel
  • When siblings were both eligible, only one sibling was randomly selected to participate in the study, and the other(s) was excluded

结局指标

主要结局

Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources.

时间窗: Immediately post-intervention and 6-months post intervention

次要结局

  • Evaluation of Problem behaviors, life-course outcomes, placement history, and service system involvement as measured from multiple informants and sources.(Immediately post-intervention, 6-months post-intervention, 2.5 years post-intervention and possible future timepoints)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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