- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01567969
Family Health and Development Project (FHDP)
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06519
- Yale University Child Study Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IICAPS
Provision of Intensive In-home Child and Adolescent Psychiatric Service, a six to seven month family-focused in-home psychiatric intervention.
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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.
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Active Comparator: Home-based CTC
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Child Out-of-control Behavior
Time Frame: Baseline up to 7 months post-baseline
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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.
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Baseline up to 7 months post-baseline
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Change in Child Out-of-control Behavior
Time Frame: Baseline to 12 months post-baseline
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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.
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Baseline to 12 months post-baseline
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Change in Child Out-of-control Behavior
Time Frame: Up to 12 months post-baseline
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Child out-of-control behavior is measured by the Retrospective Modified Overt Aggression Scale (R-MOAS) monthly from baseline to 12-months post-baseline.
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Up to 12 months post-baseline
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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)
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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.
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Baseline (measure of prior 6 months) up to 7 months post-baseline (measuring time since baseline)
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Change in Child Psychiatric Inpatient Days and Admissions
Time Frame: Baseline (measure of 6 months prior) to 12 months post-baseline
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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.
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Baseline (measure of 6 months prior) to 12 months post-baseline
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Change in Child Out-of-control Behavior
Time Frame: Baseline up to 7 months post-baseline
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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.
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Baseline up to 7 months post-baseline
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Change in Child Out-of-control Behavior
Time Frame: Baseline to 12 months post-baseline
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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.
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Baseline to 12 months post-baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Parenting Practices
Time Frame: Baseline up to 7 months post-baseline
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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).
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Baseline up to 7 months post-baseline
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Change in Parenting Practices
Time Frame: Baseline to 12 months post-baseline
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Parenting practices will be measured using the Alabama Parenting Questionnaire (APQ)administered at baseline and at 12-months post-baseline.
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Baseline to 12 months post-baseline
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Change in Parental Problem Solving
Time Frame: Baseline up to 7 months post-baseline
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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).
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Baseline up to 7 months post-baseline
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Change in Parental Problem Solving
Time Frame: Baseline to 12 months post-baseline
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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.
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Baseline to 12 months post-baseline
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Change in Parental Perception of their Child
Time Frame: Baseline up to 7 months post-baseline
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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).
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Baseline up to 7 months post-baseline
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Change in Parental Perception of their Child
Time Frame: Baseline to 12 months post-baseline
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Parental perception of their child will be measured using the Parent Cognition Scale (PCS) administered at baseline and at 12-months post-baseline.
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Baseline to 12 months post-baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph L. Woolston, M.D., Yale University
Publications and helpful links
General Publications
- Woolston JL, Adnopoz JA, Berkowitz SJ. IICAPS: A Home-Based Psychiatric Treatment for Children and Adolescents. New Haven: Yale University Press, 2007.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1102008073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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