- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03048552
Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3
November 1, 2022 updated by: Katherine Elkington, New York State Psychiatric Institute
Developed from adapting and combining two evidence-based programs, Project CONNECT (a linkage-to-services program that targets barriers within the probation and substance abuse treatment systems) and TIES (a program that teaches family engagement skills to providers), Family CONNECT is a linkage-to-services program that targets both family and system-level factors to increase youth use of and retention in substance use services.
Using Linkage Specialists embedded within probation departments, Family CONNECT will be implemented in two NYS probation departments.
This proposed study will evaluate the impact of Family CONNECT on (1) youth referral from probation to substance abuse treatment, (2) youth and family engagement in substance abuse treatment, (3) youth enrollment/retention in substance abuse treatment, and (4) youth substance use and recidivism.
Counts of youth referred, youth who start treatment, and youth retained in treatment will be obtained from the juvenile justice agency for 6-months pre-implementation of Family Connect (i.e.
baseline) and during the implementation period of e-Connect; counts of youth recidivism will be obtained 6 months following the completion of Family Connect.
This study will also identify family and probation organizational factors influencing Family CONNECT implementation in probation settings.
50 caregiver-youth dyads and up to 36 probation officers will be recruited as participants in the study.
Caregiver-youth dyads will be evaluated at baseline, 2 and 6 months; probation officers at baseline, 6, 12, and 18 months; linkage specialists at baseline, 6, 12, and 18 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
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
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Youth:
Inclusion Criteria
- Between 10-18 years of age
- English speaking
- A caregiver who will participate in the study
- MAYSI-2 score of ≥ 4 on any MAYSI-2 subscale; YASI mental health and substance use screen items; or other documented evidence of mental health or substance use problem
- Currently on probation
Exclusion Criteria 1. Cognitively unable to complete the interview
Caregiver:
Inclusion criteria
- Youth's legal guardian (or permission from legal guardian)
- Youth who will participate
- English speaking
Exclusion criteria:
1. Cognitively unable to complete the interview
Probation staff:
Inclusion criteria:
1. Currently employed at probation department
Exclusion criterion:
1. None
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care
This arm is comprised of caregiver-youth dyads randomized to work with the youth's probation officer as usual to link youth to substance use services.
|
|
Experimental: Family CONNECT
This arm is comprised of caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.
|
Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Youth Enrolled in Substance Use Treatment
Time Frame: Two years (study implementation period)
|
Count of youth participants enrolled in substance use treatment based on self-report or administrative records
|
Two years (study implementation period)
|
Youth Enrolled in Any Behavioral Health Treatment
Time Frame: Two years (study implementation period)
|
Number of youth enrolled in any behavioral health treatment (incl.
mental health and substance use) within the past 6 months
|
Two years (study implementation period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Youth Referred for Substance Use Treatment
Time Frame: Two years (study implementation period)
|
Number of youth referred to substance use treatment
|
Two years (study implementation period)
|
Youth Referred for Any Behavioral Health Treatment
Time Frame: two years (implementation period)
|
Number of youth who are referred to any behavioral health treatment
|
two years (implementation period)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Youth Initiated Substance Use Treatment
Time Frame: Two years (study implementation period)
|
Number of youth who attended an additional substance use treatment appointment following intake.
|
Two years (study implementation period)
|
Youth Initiated Any Behavioral Health Treatment
Time Frame: two years (study implementation period)
|
Number of youth who attended an additional behavioral health treatment appointment following intake.
|
two years (study implementation period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Katherine S Elkington, PhD, New York State Psychiatric Institute
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 (Actual)
November 17, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
February 7, 2017
First Submitted That Met QC Criteria
February 7, 2017
First Posted (Estimate)
February 9, 2017
Study Record Updates
Last Update Posted (Actual)
November 3, 2022
Last Update Submitted That Met QC Criteria
November 1, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7108
- R34DA039316 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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