Family Health and Development Project (FHDP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01567969
First received: March 12, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Serious Emotional Disturbance
Behavioral: Intensive In-home Child and Adolescent Psychiatric Service
Behavioral: Home-based Child Treatment Coordination
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in Child Out-of-control Behavior [ Time Frame: Baseline up to 7 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 12 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (measure of prior 6 months) up to 7 months post-baseline (measuring time since baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (measure of 6 months prior) to 12 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 7 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 7 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 7 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 7 months post-baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 12 months post-baseline ] [ Designated as safety issue: No ]
    Parental perception of their child will be measured using the Parent Cognition Scale (PCS) administered at baseline and at 12-months post-baseline.


Enrollment: 110
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IICAPS
Provision of Intensive In-home Child and Adolescent Psychiatric Service, a six to seven month family-focused in-home psychiatric 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.
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.
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.

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

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567969

Locations
United States, Connecticut
Yale University Child Study Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Joseph L. Woolston, M.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01567969     History of Changes
Other Study ID Numbers: 1102008073
Study First Received: March 12, 2012
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
mental health services
child behavior disorders
child psychiatry

Additional relevant MeSH terms:
Affective Symptoms
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 23, 2014