Family Health and Development Project

Phase 3

Completed

• Conditions: Serious Emotional Disturbance
• Interventions: Behavioral: Home-based Child Treatment Coordination; Behavioral: Intensive In-home Child and Adolescent Psychiatric Service

• Registration Number: NCT01567969
• Lead Sponsor: Yale University

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 Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-03-12
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-30
• Primary Completion: 2015-11
• Study Completion: 2016-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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)

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based CTC	Home-based Child Treatment Coordination	Provision of Home-based Child Treatment Coordination, a six to seven month child-focused case management service with monthly in-home visits with the child's parent/legal guardian.
IICAPS	Intensive In-home Child and Adolescent Psychiatric Service	Provision of Intensive In-home Child and Adolescent Psychiatric Service, a six to seven month family-focused in-home psychiatric intervention.

Primary Outcome Measures

Name	Time	Method
Change in Child Out-of-control Behavior	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.
Change in Child Psychiatric Inpatient Days and Admissions	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Parenting Practices	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	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	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.

Trial Locations

Locations (1)

Yale University Child Study Center; 🇺🇸 New Haven, Connecticut, United States