Fostering Healthy Futures Efficacy Trial for Preadolescent Youth in Foster Care

March 24, 2025 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 the investigators 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.

Study Type

Interventional

Enrollment (Actual)

426

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Denver, Adams, Arapahoe, Jeferson and Broomfield Counties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 11 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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. Fostering Healthy Futures program (FHF) including 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of 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
6 and 16 months post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of 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
6 and 16 months post intervention and possible future timepoints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Mental Health (NIMH)
The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect

Investigators

  • Principal Investigator: Heather N Taussig, PhD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 23, 2017

Study Completion (Actual)

March 23, 2017

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria

December 16, 2008

First Posted (Estimated)

December 17, 2008

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02-0516b
  • R01MH076919 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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