Clinical Trial: Family Health and Development Project

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Distur

Brief Summary: 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.

Detailed Summary:

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
Sponsor: Yale University

Current Primary Outcome:

  • Change in Child Out-of-control Behavior [ Time Frame: Baseline up to 7 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 end of study treatment (IICAPS or Home-based CTC), at approximately 6 to 7 months post-baseline.
  • Change in Child Out-of-control Behavior [ Time Frame: 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.
  • Change in Child Out-of-control Behavior [ Time Frame: Up to 12 months post-baseline ]
    Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS) monthly from baseline to 12-months post-baseline.
  • Change in Child Psychiatric Inpatient Admissions and Days [ Time Frame: 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 Psychiatric Inpatient Days and Admissions [ Time Frame: Baseline (measure of 6 months prior) to 12 months post-baseline&nbs

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change in Parenting Practices [ Time Frame: Baseline up to 7 months post-baseline ]
      Parenting practices will be measured using the Alabama Parenting Questionnaire (APQ)administered at baseline and at the end of the study treatment intervention (IICAPS or Home-based CTC).
    • Change in Parenting Practices [ Time Frame: Baseline to 12 months post-baseline ]
      Parenting practices will be measured using the Alabama Parenting Questionnaire (APQ)administered at baseline and at 12-months post-baseline.
    • Change in Parental Problem Solving [ Time Frame: Baseline up to 7 months post-baseline ]
      Parental problem solving will be measured using the Problem Solving subscale of McMaster Family Assessment Device (FAD) administered at baseline and at the end of the study treatment intervention (IICAPS or Home-based CTC).
    • Change in Parental Problem Solving [ Time Frame: Baseline to 12 months post-baseline ]
      Parental problem solving will be measured using the Problem Solving subscale of McMaster Family Assessment Device (FAD) administered at baseline and at 12-months post-baseline.
    • Change in Parental Perception of their Child [ Time Frame: Baseline up to 7 months post-baseline ]
      Parental perception of their child will be measured using the Parent Cognition Scale (PCS) administered at baseline and at the end of the study treatment intervention (IICAPS or Home-based CTC).
    • Change in Parental Perception of their Child [ Time Frame: Baseline to 12 months post-baseline ]
      Parental perception of their child will be measured using the Parent Cognition Scale (PCS) administered at baseline and at 12-months post-baseline.


    Original Secondary Outcome: Same as current

    Information By: Yale University

    Dates:
    Date Received: March 12, 2012
    Date Started: May 2011
    Date Completion:
    Last Updated: October 12, 2016
    Last Verified: October 2016