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Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3

Primary Purpose

Substance Use, Substance Abuse, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family CONNECT
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use focused on measuring drug use, drug addiction, drug habituation, drug use disorders, organic mental disorders, substance-induced, substance abuse, substance addiction, substance dependence, substance use disorders

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Youth:

Inclusion Criteria

  1. Between 10-18 years of age
  2. English speaking
  3. A caregiver who will participate in the study
  4. 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
  5. Currently on probation

Exclusion Criteria 1. Cognitively unable to complete the interview

Caregiver:

Inclusion criteria

  1. Youth's legal guardian (or permission from legal guardian)
  2. Youth who will participate
  3. 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard of Care

    Family CONNECT

    Arm Description

    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.

    This arm is comprised of caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.

    Outcomes

    Primary Outcome Measures

    Youth Enrolled in Substance Use Treatment
    Count of youth participants enrolled in substance use treatment based on self-report or administrative records
    Youth Enrolled in Any Behavioral Health Treatment
    Number of youth enrolled in any behavioral health treatment (incl. mental health and substance use) within the past 6 months

    Secondary Outcome Measures

    Youth Referred for Substance Use Treatment
    Number of youth referred to substance use treatment
    Youth Referred for Any Behavioral Health Treatment
    Number of youth who are referred to any behavioral health treatment

    Full Information

    First Posted
    February 7, 2017
    Last Updated
    November 1, 2022
    Sponsor
    New York State Psychiatric Institute
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03048552
    Brief Title
    Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3
    Official Title
    Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 17, 2016 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    December 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    New York State Psychiatric Institute
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use, Substance Abuse, Substance Use Disorders, Substance-Related Disorders, Substance Dependence, Substance Related Problem
    Keywords
    drug use, drug addiction, drug habituation, drug use disorders, organic mental disorders, substance-induced, substance abuse, substance addiction, substance dependence, substance use disorders

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study is a randomized control trial. Caregiver-youth dyads are randomized to either the control (standard of care) or experimental (Family CONNECT) group based on the youth's probation officer (randomization occurs at the level of the youth's probation officer). If randomized to the control (standard of care) group, caregiver-youth dyads will work with their probation officer as usual to link to substance use services. If randomized to the experimental (Family CONNECT) group, caregiver-youth dyads will work with a linkage specialist to link to substance use services. Youth in both groups will be compared to a baseline stand of care collected during the pre-implementation period.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Family CONNECT
    Arm Type
    Experimental
    Arm Description
    This arm is comprised of caregiver-youth dyads randomized to work with linkage specialists to link youth to substance use services.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Family CONNECT
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Youth Enrolled in Substance Use Treatment
    Description
    Count of youth participants enrolled in substance use treatment based on self-report or administrative records
    Time Frame
    Two years (study implementation period)
    Title
    Youth Enrolled in Any Behavioral Health Treatment
    Description
    Number of youth enrolled in any behavioral health treatment (incl. mental health and substance use) within the past 6 months
    Time Frame
    Two years (study implementation period)
    Secondary Outcome Measure Information:
    Title
    Youth Referred for Substance Use Treatment
    Description
    Number of youth referred to substance use treatment
    Time Frame
    Two years (study implementation period)
    Title
    Youth Referred for Any Behavioral Health Treatment
    Description
    Number of youth who are referred to any behavioral health treatment
    Time Frame
    two years (implementation period)
    Other Pre-specified Outcome Measures:
    Title
    Youth Initiated Substance Use Treatment
    Description
    Number of youth who attended an additional substance use treatment appointment following intake.
    Time Frame
    Two years (study implementation period)
    Title
    Youth Initiated Any Behavioral Health Treatment
    Description
    Number of youth who attended an additional behavioral health treatment appointment following intake.
    Time Frame
    two years (study implementation period)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Katherine S Elkington, PhD
    Organizational Affiliation
    New York State Psychiatric Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Family Engagement, Cross-System Linkage to Substance Use Treatment for Juvenile Probationers -- Phase 3

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