Family Health and Development Project

NCT ID: NCT01567969

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2016-02-29

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.

Conditions

Serious Emotional Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

IICAPS

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

Group Type: EXPERIMENTAL

Intensive In-home Child and Adolescent Psychiatric Service

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Home-based Child Treatment Coordination

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph L. Woolston, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University Child Study Center

New Haven, Connecticut, United States

Countries

United States

References

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

Reference Type: BACKGROUND

Other Identifiers

1102008073

Identifier Type: -

Identifier Source: org_study_id