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Support To Reunite Involve and Value Each Other (STRIVE)

Primary Purpose

Family Relations, Runaway Behavior, Risky Sexual Behavior

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
STRIVE family intervention
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Family Relations focused on measuring Runaway youth, Homeless youth, Family intervention, Family functioning, HIV risk behavior, HIV Seronegativity

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Youth: Age 12-17 who ran away or were told to leave home within the past 6 months. Must provide assent and parent/guardian must provide informed consent.
  • Parent/guardian: must be parent/guardian of participating youth who ran away. Must provide informed consent.

Exclusion Criteria:

  • Youth: total time away from home exceeds 12 months. Obvious cognitive impairment. Sexual or physical abuse from the parent/guardian. Lack of assent/consent.
  • Parent/guardian: obvious cognitive impairment. Lack of consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Improved residential stability

    Secondary Outcome Measures

    Reduced HIV risk behavior

    Full Information

    First Posted
    October 15, 2009
    Last Updated
    May 11, 2023
    Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00996541
    Brief Title
    Support To Reunite Involve and Value Each Other
    Acronym
    STRIVE
    Official Title
    Diverting Homeless Youth From Chronic Homelessness and Risk for HIV
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Runaway and homeless youth are at risk for HIV based upon their rates of substance use, particularly injection drug use, unprotected sexual intercourse, multiple partners, and sexually transmitted diseases. Risk increases as the time away from home increases. STRIVE is a family intervention aimed at increasing residential stability, decreasing runaway episodes, and decreasing HIV risk. Families are randomly assigned to a cognitive-behavioral skills-building intervention consisting of five weekly sessions delivered at family homes, or are assigned to standard care. Sessions are aimed at increasing problem solving, role clarity, and positive interactions. It is hypothesized that the intervention will result in improved family dynamics, less runaway behavior, and less risky behavior.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Family Relations, Runaway Behavior, Risky Sexual Behavior, Substance Use
    Keywords
    Runaway youth, Homeless youth, Family intervention, Family functioning, HIV risk behavior, HIV Seronegativity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    302 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    STRIVE family intervention
    Intervention Description
    Adolescent and parent attend a 5-session family-oriented cognitive-behavioral intervention aimed at giving runaway youths and their parents the tools to effectively deal with conflict.
    Primary Outcome Measure Information:
    Title
    Improved residential stability
    Time Frame
    Assessed up to 24 months
    Secondary Outcome Measure Information:
    Title
    Reduced HIV risk behavior
    Time Frame
    Up to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Youth: Age 12-17 who ran away or were told to leave home within the past 6 months. Must provide assent and parent/guardian must provide informed consent. Parent/guardian: must be parent/guardian of participating youth who ran away. Must provide informed consent. Exclusion Criteria: Youth: total time away from home exceeds 12 months. Obvious cognitive impairment. Sexual or physical abuse from the parent/guardian. Lack of assent/consent. Parent/guardian: obvious cognitive impairment. Lack of consent.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22443839
    Citation
    Milburn NG, Iribarren FJ, Rice E, Lightfoot M, Solorio R, Rotheram-Borus MJ, Desmond K, Lee A, Alexander K, Maresca K, Eastmen K, Arnold EM, Duan N. A family intervention to reduce sexual risk behavior, substance use, and delinquency among newly homeless youth. J Adolesc Health. 2012 Apr;50(4):358-64. doi: 10.1016/j.jadohealth.2011.08.009. Epub 2011 Oct 26.
    Results Reference
    result

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