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Family Health and Development Project (FHDP)

Primary Purpose

Serious Emotional Disturbance

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intensive In-home Child and Adolescent Psychiatric Service
Home-based Child Treatment Coordination
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Serious Emotional Disturbance focused on measuring mental health services, child behavior disorders, child psychiatry

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IICAPS

Home-based CTC

Arm Description

Provision of Intensive In-home Child and Adolescent Psychiatric Service, a six to seven month family-focused in-home psychiatric intervention.

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.

Outcomes

Primary Outcome Measures

Change in Child Out-of-control Behavior
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
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
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
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
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 Out-of-control Behavior
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.
Change in Child Out-of-control Behavior
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 Outcome Measures

Change in Parenting Practices
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
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
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
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
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
Parental perception of their child will be measured using the Parent Cognition Scale (PCS) administered at baseline and at 12-months post-baseline.

Full Information

First Posted
March 12, 2012
Last Updated
October 12, 2016
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01567969
Brief Title
Family Health and Development Project
Acronym
FHDP
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 Disturbed Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serious Emotional Disturbance
Keywords
mental health services, child behavior disorders, child psychiatry

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IICAPS
Arm Type
Experimental
Arm Description
Provision of Intensive In-home Child and Adolescent Psychiatric Service, a six to seven month family-focused in-home psychiatric intervention.
Arm Title
Home-based CTC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive In-home Child and Adolescent Psychiatric Service
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home-based Child Treatment Coordination
Intervention Description
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 Outcome Measure Information:
Title
Change in Child Out-of-control Behavior
Description
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.
Time Frame
Baseline up to 7 months post-baseline
Title
Change in Child Out-of-control Behavior
Description
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.
Time Frame
Baseline to 12 months post-baseline
Title
Change in Child Out-of-control Behavior
Description
Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS) monthly from baseline to 12-months post-baseline.
Time Frame
Up to 12 months post-baseline
Title
Change in Child Psychiatric Inpatient Admissions and Days
Description
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.
Time Frame
Baseline (measure of prior 6 months) up to 7 months post-baseline (measuring time since baseline)
Title
Change in Child Psychiatric Inpatient Days and Admissions
Description
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.
Time Frame
Baseline (measure of 6 months prior) to 12 months post-baseline
Title
Change in Child Out-of-control Behavior
Description
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.
Time Frame
Baseline up to 7 months post-baseline
Title
Change in Child Out-of-control Behavior
Description
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.
Time Frame
Baseline to 12 months post-baseline
Secondary Outcome Measure Information:
Title
Change in Parenting Practices
Description
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).
Time Frame
Baseline up to 7 months post-baseline
Title
Change in Parenting Practices
Description
Parenting practices will be measured using the Alabama Parenting Questionnaire (APQ)administered at baseline and at 12-months post-baseline.
Time Frame
Baseline to 12 months post-baseline
Title
Change in Parental Problem Solving
Description
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).
Time Frame
Baseline up to 7 months post-baseline
Title
Change in Parental Problem Solving
Description
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.
Time Frame
Baseline to 12 months post-baseline
Title
Change in Parental Perception of their Child
Description
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).
Time Frame
Baseline up to 7 months post-baseline
Title
Change in Parental Perception of their Child
Description
Parental perception of their child will be measured using the Parent Cognition Scale (PCS) administered at baseline and at 12-months post-baseline.
Time Frame
Baseline to 12 months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph L. Woolston, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Woolston JL, Adnopoz JA, Berkowitz SJ. IICAPS: A Home-Based Psychiatric Treatment for Children and Adolescents. New Haven: Yale University Press, 2007.
Results Reference
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Family Health and Development Project

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