- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02037750
Foster Teens' Risk During Transition (LINKS)
November 20, 2018 updated by: Oregon Social Learning Center
Foster Teens' Risk During Transition: Preventing Drug Use, HIV, & School Problems
The purpose of this study is to conduct a randomized effectiveness trial to determine whether adding a preventive intervention at the transition from elementary to middle school is effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use, participation in HIV- risking sexual behavior, delinquency, mental health problems, and school failure for young adolescents in foster care.
The proposed LINKS intervention marries the goals of child welfare and educational systems.
The aims are: a) to determine the effectiveness of the LINKS intervention on key behavioral health and school adjustment outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to examine cost effectiveness and cost avoidance of LINKS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
173
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92182-1948
- San Diego State University Foundation
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Oregon
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Eugene, Oregon, United States, 97401
- Oregon Social Learning Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 13 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- the focal youth will be transitioning into middle school
- the focal youth is in either a foster or kinship care home
- the focal youth has been in the home for a minimum of 30 days (including those who are newly placed in care and those moving from another type of placement).
Exclusion Criteria:
- youth who are are considered medically fragile (i.e., severely physically or mentally handicapped)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: LINKS
Foster parent and child participate in 16-week intervention
|
In the LINKS, foster/kin parents will participate in weekly group meetings led by well-trained and supervised paraprofessional facilitators (school behavioral aids and foster parents) where the curriculum is based on parent management training (PMT).
In previous studies, attendance at such groups has been high, averaging about 75-80%.
Missed sessions will be "made up" with an in-person visit to the foster/kin home during the week of the original session.
In addition, youth in the intervention condition will receive individual skill building sessions from a Life Skills Coach to increase their competency at goal setting, refusal skills, and peer relations.
|
|
No Intervention: Services as Usual
Foster parent and child receive standard services through child welfare system
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Placement Failures
Time Frame: between Baseline and 18-Months later
|
between Baseline and 18-Months later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia Chamberlain, Phd, Oregon Social Learning Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
January 13, 2014
First Submitted That Met QC Criteria
January 14, 2014
First Posted (Estimate)
January 16, 2014
Study Record Updates
Last Update Posted (Actual)
November 23, 2018
Last Update Submitted That Met QC Criteria
November 20, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01DA032634 (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.
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