Intervention Development and Pilot for Foster Care Youth

Child Abuse Clinical Trial

Official title:

Intervention Development and Pilot for Foster Care Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809315
• Other study ID #: 02-0516a
• Secondary ID: R21MH067618
• Status: Completed
• Phase: N/A
• Start date: August 2002
• Est. completion date: March 23, 2017

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 23, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Abuse

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado, Denver	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Mental Health (NIMH), The Kempe Foundation for the Prevention and Treatment of Child Abuse and Neglect

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Child mental health, social & behavioral functioning and quality of life as measured from multiple informants and sources.		Immediately post-intervention and 6-months post intervention
Secondary	Evaluation of Problem behaviors, life-course outcomes, placement history, and service system involvement as measured from multiple informants and sources.		Immediately post-intervention, 6-months post-intervention, 2.5 years post-intervention and possible future timepoints