Intervention Development and Pilot for Foster Care Youth
| Tracking Information | |||||
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| First Received Date ICMJE | December 16, 2008 | ||||
| Last Updated Date | January 29, 2013 | ||||
| Start Date ICMJE | August 2002 | ||||
| Estimated Primary Completion Date | December 2018 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Child mental health, social, academic, & behavioral functioning and quality of life as measured from multiple informants and sources. [ Time Frame: Immediately post-intervention and 6-months post intervention ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00809315 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intervention Development and Pilot for Foster Care Youth | ||||
| Official Title ICMJE | Intervention Development and Pilot for Foster Care Youth | ||||
| Brief Summary | 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. |
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| 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 our prior longitudinal work with children in foster care, we 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 us 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, we 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. We 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 we will modify the assessment battery, protocol, and manuals following the pilot phase and prior to our application for an R01 to conduct a large-scale efficacy trial. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Child Abuse | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 152 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2018 (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:
Exclusion Criteria:
When siblings were both eligible, only one sibling was randomly selected to participate in the study, and the other(s) was excluded |
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| Gender | Both | ||||
| Ages | 9 Years to 11 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00809315 | ||||
| Other Study ID Numbers ICMJE | 02-0516a, R21MH067618 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Colorado, Denver | ||||
| Study Sponsor ICMJE | University of Colorado, Denver | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Colorado, Denver | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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