Family Health and Development Project

Serious Emotional Disturbance Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567969
• Other study ID #: 1102008073
• Status: Completed
• Phase: Phase 3
• First received: March 12, 2012
• Last updated: October 12, 2016
• Start date: May 2011
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Affective Symptoms
• Serious Emotional Disturbance

Intervention

Behavioral:
• Intensive In-home Child and Adolescent Psychiatric Service
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
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.

Locations

Country	Name	City	State
United States	Yale University Child Study Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Woolston JL, Adnopoz JA, Berkowitz SJ. IICAPS: A Home-Based Psychiatric Treatment for Children and Adolescents. New Haven: Yale University Press, 2007.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to 7 months post-baseline	No
Primary	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.	Baseline to 12 months post-baseline	No
Primary	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.	Up to 12 months post-baseline	No
Primary	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.	Baseline (measure of prior 6 months) up to 7 months post-baseline (measuring time since baseline)	No
Primary	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.	Baseline (measure of 6 months prior) to 12 months post-baseline	No
Primary	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.	Baseline up to 7 months post-baseline	No
Primary	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.	Baseline to 12 months post-baseline	No
Secondary	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).	Baseline up to 7 months post-baseline	No
Secondary	Change in Parenting Practices	Parenting practices will be measured using the Alabama Parenting Questionnaire (APQ)administered at baseline and at 12-months post-baseline.	Baseline to 12 months post-baseline	No
Secondary	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).	Baseline up to 7 months post-baseline	No
Secondary	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.	Baseline to 12 months post-baseline	No
Secondary	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).	Baseline up to 7 months post-baseline	No
Secondary	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.	Baseline to 12 months post-baseline	No