Overview

This trial is active, not recruiting.

Condition child abuse
Treatments assessment, fostering healthy futures (fhf)
Sponsor University of Colorado, Denver
Collaborator National Institute of Mental Health (NIMH)
Start date June 2007
End date December 2020
Trial size 256 participants
Trial identifier NCT00810056, 02-0516b, R01MH076919

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Cognitive, academic achievement and mental health screening assessment and report.
assessment
Cognitive, academic achievement, and mental health screening assessment and report.
(Experimental)
Cognitive, academic achievement and mental health screening assessment and report. Fostering Healthy Futures program (FHF) including weekly therapeutic skill groups and mentoring over a 9-month period.
assessment
Cognitive, academic achievement, and mental health screening assessment and report.
fostering healthy futures (fhf)
Weekly therapeutic skill groups and mentoring over a 9-month period.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 9 years up to 11 years old.

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

Additional Information

Official title Fostering Healthy Futures Efficacy Trial for Preadolescent Youth in Foster Care
Principal investigator Heather N Taussig, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.