Fostering Healthy Futures Efficacy Trial for Preadolescent Youth in Foster Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00810056
First received: December 16, 2008
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

This is a multi-county randomized controlled trial of the Fostering Healthy Futures (FHF) preventive intervention program (consisting of mentoring and skills groups) with 256 maltreated preadolescent youth in out-of-home care. It is hypothesized that participation in the FHF program will result in better functioning in cognitive, social, and behavioral domains, and that these gains will result in improved mental health functioning, quality of life, and reductions in problem behaviors and adverse life-course outcomes.


Condition Intervention
Child Abuse
Other: Assessment
Behavioral: Fostering Healthy Futures (FHF)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fostering Healthy Futures Efficacy Trial for Preadolescent Youth in Foster Care

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Child mental health, social, & behavioral functioning and quality of life as measured from multiple informants and sources. [ Time Frame: 6 and 16 months post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Problem behaviors, life-course outcomes, placement history, and service system involvement as measured from multiple informants and sources. [ Time Frame: 6 and 16 months post intervention and possible future timepoints ] [ Designated as safety issue: No ]

Estimated Enrollment: 256
Study Start Date: June 2007
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Assessment only
Cognitive, academic achievement and mental health screening assessment and report.
Other: Assessment
Cognitive, academic achievement, and mental health screening assessment and report.
Experimental: Assessment + FHF
Cognitive, academic achievement and mental health screening assessment and report. Weekly therapeutic skill groups and mentoring over a 9-month period.
Other: Assessment
Cognitive, academic achievement, and mental health screening assessment and report.
Behavioral: Fostering Healthy Futures (FHF)
Weekly therapeutic skill groups and mentoring over a 9-month period.

Detailed Description:

Youth with a history of maltreatment and foster care placement are at risk for a host of mental health, behavioral, and social problems, resulting in adverse life-course outcomes of great public health significance. This is a 5-year efficacy trial of the Fostering Healthy Futures Program (FHF), a preventive intervention designed to promote prosocial development, and to reduce problem behaviors for youth in foster care. FHF is an innovative, culturally-sensitive and multi-component intervention for 9-11-year-old children who have been maltreated and placed in foster care. Through a 9-month intervention that includes screening assessments, one-on-one mentoring, and skills groups, FHF targets cognitive, social and behavioral domains in order to build competencies, improve mental health functioning and quality of life, and reduce problem behaviors and adverse life outcomes (e.g. arrests, school dropout, restrictive placements). Assessments with youth, caregivers and teachers will be conducted at baseline (pre-randomization), post-intervention, and 1-year follow-up. Data will also include child welfare, educational, and juvenile justice records. A randomized controlled pilot trial of FHF in one county has produced program manuals for the mentoring and skills group components, and evidence of program feasibility, with high recruitment and retention rates. The FHF pilot study has demonstrated positive preliminary effects on putative mediators. A multi-county randomized controlled trial of the FHF program with 256 youth will enable us to: 1) examine intervention effects on both proximal and distal outcomes, 2) examine potential moderators of the intervention, 3) conduct mediational analyses to identify the mechanisms by which the program may enhance outcomes, and 4) conduct within-group analyses. The goal is to design more efficacious interventions, thereby reducing disability, morbidity, and mortality, not only for youth in foster care, but for all high-risk youth.

  Eligibility

Ages Eligible for Study:   9 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All of the 9-11-year-old children court-ordered into out-of-home care (as a result of maltreatment) over the prior year in participating counties, including:

  1. Youth placed in group homes, foster homes, and with kin
  2. Youth with significant behavior problems
  3. Youth who meet criteria for mental health diagnoses or dual diagnosis
  4. Youth with mild cognitive impairment

Exclusion Criteria:

  1. Youth who reunify before the beginning of the intervention
  2. Youth with significant cognitive, behavioral, and/or mental health impairment that interfered with either with their ability to benefit from the prevention program or to participate safely
  3. Youth who were not proficient enough in English to participate
  4. Youth who lived too far (more than 35 minutes) from sites where groups were held
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810056

Locations
United States, Colorado
Denver, Adams, Arapahoe, Jeferson and Broomfield Counties
Denver, Colorado, United States, 80218
Sponsors and Collaborators
University of Colorado, Denver
The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect
Investigators
Principal Investigator: Heather N Taussig, PhD University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00810056     History of Changes
Other Study ID Numbers: 02-0516b, R01MH076919
Study First Received: December 16, 2008
Last Updated: January 29, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
Child abuse and neglect
Out-of-home care
Mentoring
Skills groups
Assessment
Functioning as a result of maltreatment and placement in out-of-home care

ClinicalTrials.gov processed this record on April 17, 2014