Intervention Development and Pilot for Foster Care Youth
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado, Denver
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- Youth placed in group homes, foster homes, and with kin
- Youth with significant behavior problems
- Youth who meet criteria for mental health diagnoses or dual diagnosis
- Youth with mild cognitive impairment
Exclusion Criteria:
- Youth who reunify before the beginning of the intervention
- 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
- Youth who were not proficient enough in English to participate
- 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
Study Plan
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.
|
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.
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: Immediately post-intervention and 6-months post intervention
|
Immediately post-intervention and 6-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: Immediately post-intervention, 6-months post-intervention, 2.5 years post-intervention and possible future timepoints
|
Immediately post-intervention, 6-months post-intervention, 2.5 years post-intervention and possible future timepoints
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather N Taussig, PhD, University of Denver
Publications and helpful links
General 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.
- Taussig HN, Culhane SE. Impact of a mentoring and skills group program on mental health outcomes for maltreated children in foster care. Arch Pediatr Adolesc Med. 2010 Aug;164(8):739-46. doi: 10.1001/archpediatrics.2010.124.
- Taussig HN, Culhane SE, Garrido E, Knudtson MD. RCT of a mentoring and skills group program: placement and permanency outcomes for foster youth. Pediatrics. 2012 Jul;130(1):e33-9. doi: 10.1542/peds.2011-3447. Epub 2012 Jun 11.
- Hambrick E, Lee SK, Weiler L, Collins JO, Rhodes T, Taussig H. Engagement in a Preventive Intervention for Preadolescent Children in Foster Care: Considerations for Intervention Design. Child Psychiatry Hum Dev. 2022 Mar 18. doi: 10.1007/s10578-022-01341-8. Online ahead of print.
- Taussig HN, Dmitrieva J, Garrido EF, Cooley JL, Crites E. Fostering Healthy Futures Preventive Intervention for Children in Foster Care: Long-term Delinquency Outcomes from a Randomized Controlled Trial. Prev Sci. 2021 Nov;22(8):1120-1133. doi: 10.1007/s11121-021-01235-6. Epub 2021 Apr 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 02-0516a
- R21MH067618 (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.