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Fostering Healthy Futures Efficacy Trial for Preadolescent Youth in Foster Care

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ClinicalTrials.gov Identifier: NCT00810056
Recruitment Status : Active, not recruiting
First Posted : December 17, 2008
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE December 16, 2008
First Posted Date  ICMJE December 17, 2008
Last Update Posted Date June 13, 2019
Study Start Date  ICMJE June 2007
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
Child mental health, social, academic, & behavioral functioning and quality of life as measured from multiple informants and sources. [ Time Frame: 6 and 16 months post intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fostering Healthy Futures Efficacy Trial for Preadolescent Youth in Foster Care
Official Title  ICMJE Fostering Healthy Futures Efficacy Trial for Preadolescent Youth in Foster Care
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Child Abuse
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Assessment only
    Cognitive, academic achievement and mental health screening assessment and report.
    Intervention: Other: Assessment
  • 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.
    Interventions:
    • Other: Assessment
    • Behavioral: Fostering Healthy Futures (FHF)
Publications * Taussig HN, Culhane SE, Hettleman D. Fostering healthy futures: an innovative preventive intervention for preadolescent youth in out-of-home care. Child Welfare. 2007 Sep-Oct;86(5):113-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
256
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00810056
Other Study ID Numbers  ICMJE 02-0516b
R01MH076919 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect
Investigators  ICMJE
Principal Investigator: Heather N Taussig, PhD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP