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Intervention Development and Pilot for Foster Care Youth

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00809315
First received: December 16, 2008
Last updated: December 5, 2016
Last verified: December 2016
  Purpose
The purpose of this study is to develop, standardize and provide a preliminary test of a novel intervention for preadolescent maltreated youth in out-of-home care. It is hypothesized that the preventive intervention, which is known as Fostering Healthy Futures (FHF) and which consists of therapeutic skills groups and mentoring, will improve mental health, social, academic and behavioral functioning and reduce youths' initiation of, and participation in, problem behaviors.

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 (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervention Development and Pilot for Foster Care Youth

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources. [ Time Frame: Immediately post-intervention and 6-months post intervention ]

Secondary Outcome Measures:
  • Evaluation of Problem behaviors, life-course outcomes, placement history, and service system involvement as measured from multiple informants and sources. [ Time Frame: Immediately post-intervention, 6-months post-intervention, 2.5 years post-intervention and possible future timepoints ]

Enrollment: 152
Study Start Date: August 2002
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: Fostering Healthy Futures (FHF) 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:

This R21 application for a 3-year exploratory/development grant for intervention research is designed to develop, standardize and provide a preliminary test of a novel intervention for children, ages 9-11, placed in out-of-home care. Children and adolescents with a history of maltreatment and subsequent placement in foster care are at risk for substantial mental health and behavioral problems of great public health significance. In the prior longitudinal work with children in foster care, the investigators have described the population, examined child welfare system impact, and identified modifiable psychosocial risk and protective factors. These pre-intervention activities, supported by the principal investigator's K01 award, have enabled the investigator to address important methodological issues that have hampered the development of intervention efforts targeting this high-risk population.

Based on this pre-intervention research, feedback from focus group participants, and a review of other efficacious programs for high-risk youth, the investigators propose to design an intervention for preadolescent youth in foster care consisting of three primary components: assessment and advocacy, mentoring, and therapeutic skills groups. The proposed R21 activities include developing the assessment battery and intervention protocol, manualizing the treatment, estimating recruitment and attrition rates, and conducting a small-scale randomized-controlled pilot study of the intervention. The goals of the intervention will be to improve mental health, social, academic and behavioral functioning and to reduce youths' initiation of, and participation in, problem behaviors. The investigators will conduct a preliminary examination of whether these proximal outcomes are moderated by baseline characteristics and/or mediated by the process variables targeted by the intervention. Estimates of effect size will be used to determine the sample size needed for adequate power to conduct a full-scale randomized controlled trial. The pilot study will also focus on issues of feasibility, program uptake, and replicability, and the investigators will modify the assessment battery, protocol, and manuals following the pilot phase and prior to the application for an R01 to conduct a large-scale efficacy trial.

  Eligibility

Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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 from sites where groups were hel

When siblings were both eligible, only one sibling was randomly selected to participate in the study, and the other(s) was excluded

  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: NCT00809315

Locations
United States, Colorado
University of Colorado, Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Heather N Taussig, PhD University of Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00809315     History of Changes
Other Study ID Numbers: 02-0516a
R21MH067618 ( U.S. NIH Grant/Contract )
Study First Received: December 16, 2008
Last Updated: December 5, 2016

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 September 19, 2017