Intervention Development and Pilot for Foster Care Youth
|ClinicalTrials.gov Identifier: NCT00809315|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2008
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Child Abuse||Other: Assessment Behavioral: Fostering Healthy Futures (FHF)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Intervention Development and Pilot for Foster Care Youth|
|Study Start Date :||August 2002|
|Estimated Primary Completion Date :||December 2020|
Active Comparator: Assessment only
Cognitive, academic achievement and mental health screening assessment and report.
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.
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.
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809315
|United States, Colorado|
|University of Colorado, Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Heather N Taussig, PhD||University of Denver|