Clinical trial NCT01567969: Family Health and Development Project
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Serious Emotional Disturbance
Keywords: mental health services
child behavior disorders
child psychiatry
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-03-30
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in Child Out-of-control Behavior
timeFrame: Baseline up to 7 months post-baseline
measure: Change in Child Out-of-control Behavior
timeFrame: Baseline to 12 months post-baseline
measure: Change in Child Out-of-control Behavior
timeFrame: Up to 12 months post-baseline
measure: Change in Child Psychiatric Inpatient Admissions and Days
timeFrame: Baseline (measure of prior 6 months) up to 7 months post-baseline (measuring time since baseline)
measure: Change in Child Psychiatric Inpatient Days and Admissions
timeFrame: Baseline (measure of 6 months prior) to 12 months post-baseline
measure: Change in Child Out-of-control Behavior
timeFrame: Baseline up to 7 months post-baseline
measure: Change in Child Out-of-control Behavior
timeFrame: Baseline to 12 months post-baseline
Secondary outcomes:
measure: Change in Parenting Practices
timeFrame: Baseline up to 7 months post-baseline
measure: Change in Parenting Practices
timeFrame: Baseline to 12 months post-baseline
measure: Change in Parental Problem Solving
timeFrame: Baseline up to 7 months post-baseline
measure: Change in Parental Problem Solving
timeFrame: Baseline to 12 months post-baseline
measure: Change in Parental Perception of their Child
timeFrame: Baseline up to 7 months post-baseline
measure: Change in Parental Perception of their Child
timeFrame: Baseline to 12 months post-baseline
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Joseph L. Woolston, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woolston JL, Adnopoz JA, Berkowitz SJ. IICAPS: A Home-Based Psychiatric Treatment for Children and Adolescents. New Haven: Yale University Press, 2007.