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Completed

NCT Number: NCT01567969

Family Health and Development Project

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.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yale University Child Study Center

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Intensive In-home Child and Adolescent Psychiatric Service

Behavioral

A six to seven month intensive intervention provided by a clinical team consisting of a master's-level clinician and a bachelor's-level mental health counselor delivering comprehensive psychiatric and case management services in the child's home. One or both members of the team works with the child and the family three times a week in the home. Delivery of direct and indirect services average 5.5 hours of service per week.

Home-based Child Treatment Coordination

Behavioral

A six to seven month home-based case management service delivered by a master's level clinician. The coordinator meets with the child's parent/legal guardian in the child's home once a month and conducts weekly phone conversations to facilitate referral and access to appropriate mental health services for the child.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in Child Psychiatric Inpatient Days and Admissions

    Time frame: 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.

  6. Change in Child Out-of-control Behavior

    Time frame: Baseline up to 7 months post-baseline

    Child out-of-control behavior as measured by the Child Behavior Checklist (CBCL). 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.

  7. Change in Child Out-of-control Behavior

    Time frame: Baseline to 12 months post-baseline

    Child out-of-control behavior as measured by the Child Behavior Checklist (CBCL). This instrument is administered at baseline and at 12 months post-baseline.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study 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 Disturbed Children

Acronym: FHDP

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Mar 30, 2012
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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