NCT02037750

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

5.5 years

First QC Date

January 13, 2014

Last Update Submit

November 20, 2018

Conditions

Keywords

foster careschool adjustment

Outcome Measures

Primary Outcomes (1)

  • Number of Placement Failures

    between Baseline and 18-Months later

Study Arms (2)

LINKS

EXPERIMENTAL

Foster parent and child participate in 16-week intervention

Behavioral: LINKS

Services as Usual

NO INTERVENTION

Foster parent and child receive standard services through child welfare system

Interventions

LINKSBEHAVIORAL

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.

LINKS

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • youth who are are considered medically fragile (i.e., severely physically or mentally handicapped)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Diego State University Foundation

San Diego, California, 92182-1948, United States

Location

Oregon Social Learning Center

Eugene, Oregon, 97401, United States

Location

Study Officials

  • Patricia Chamberlain, Phd

    Oregon Social Learning Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 16, 2014

Study Start

December 1, 2012

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations