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临床试验/NCT01567969
NCT01567969已完成3 期

Family Health and Development Project: Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) vs. Home-based Child Treatment Coordination (Home-based CTC) for Seriously Emotionally Disturbed Children

Yale University2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
110
试验地点
2
主要终点
Change in Child Psychiatric Inpatient Days and Admissions

研究概览

简要总结

The Family Health and Development Project (FHDP) is a randomized controlled trial to evaluate the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) intervention, targeting emotionally, behaviorally, and/or psychiatrically disordered children at risk of a psychiatric inpatient admission and their families. Children and families are randomized to receive IICAPS or Home-based Child Treatment Coordination (Home-based CTC), a home-based case management intervention for coordination of mental health services for children. Approximately 144 children and their families will be enrolled for a 12 month study period. Data will be collected through interviews with the child's parent/legal guardian, and from the child's teacher, the child's school, and the Department of Social Services (claims data). This study will test the hypotheses that children receiving IICAPS will be less likely to exhibit out-of-control behaviors and less likely to experience a psychiatric hospitalization and/or out-of-home placement during and up to six months post-discharge from services.

详细描述

The Family Health and Development Project (FHDP) is a randomized controlled trial to evaluate the effectiveness of the Intensive In-home Child and Adolescent Psychiatric Service (IICAPS) intervention, targeting emotionally, behaviorally, and/or psychiatrically disordered children at risk of a psychiatric inpatient admission and their families. Children and families are randomized to receive IICAPS or Home-based Child Treatment Coordination (Home-based CTC), a home-based case management intervention for coordination of mental health services for children. Approximately 144 children and their families will be enrolled for a 12 month study period. Each study intervention is six to seven months in duration, with approximately 6 additional months of follow-up.

Data are collected from the identified child's parent/legal guardian during three in-person assessment interviews (at enrollment, at end of study treatment, and at 12-months), and during brief monthly phone interviews. Data are collected on child psychiatric symptoms and behavior, child psychiatric inpatient admissions and other service utilization, parenting practices, and parental problem solving skills. Additional data are collected from the child's teacher (child's behavior at school) and the child's school (days missed, suspensions, expulsions, disciplinary action) at baseline, 6-months, and 12-months. Service utilization data will be collected from the Connecticut Department of Social Services using claims data.

The main study aim is to evaluate the efficacy of IICAPS for youth with serious and pervasive mental health problems that places them at risk for institutional placement, and test the hypotheses that children receiving IICAPS will be less likely to exhibit out-of-control behaviors and less likely to experience a psychiatric hospitalization and/or out-of-home placement during and up to six months post-discharge from services. The second study aim is to evaluate how the efficacy of IICAPS for youth with serious and pervasive mental health problems is achieved, with specific focus on parenting practices, parental problem solving techniques, and parental perception of the child.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • child has a Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis
  • child at risk of psychiatric hospitalization due to serious out-of-control behaviors
  • child resides in home of legal guardian, who is primary caregiver
  • child insured by Medicaid
  • score in the borderline clinical or clinical range on the Externalizing Scale of the Child Behavior Checklist (CBCL)

排除标准

  • referred to IICAPS by a probation officer
  • suffers from an unstable, chronic medical comorbidity
  • prior receipt of IICAPS

结局指标

主要结局

Change in Child Psychiatric Inpatient Days and Admissions

时间窗: Baseline (measure of 6 months prior) to 12 months post-baseline

Child psychiatric inpatient admissions and days will be collected for the six-months prior to study enrollment, and measured against child psychiatric inpatient admissions and days from baseline to 12 months post-baseline.

Change in Child Psychiatric Inpatient Admissions and Days

时间窗: Baseline (measure of prior 6 months) up to 7 months post-baseline (measuring time since baseline)

Child psychiatric inpatient admissions and days will be collected for the six-months prior to study enrollment, and measured against child psychiatric inpatient admissions and days from baseline to the end of the study treatment intervention (IICAPS or Home-based CTC), at approximately 6 to 7 months post-baseline.

Change in Child Out-of-control Behavior

时间窗: Baseline to 12 months post-baseline

Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS). This instrument is administered at baseline and at the 12 months post-baseline.

次要结局

  • Change in Parenting Practices(Baseline to 12 months post-baseline)
  • Change in Parental Problem Solving(Baseline to 12 months post-baseline)
  • Change in Parental Perception of their Child(Baseline to 12 months post-baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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