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Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback

Primary Purpose

Substance Use, HIV Risk Behavior

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Values Affirmation
Risk Feedback
Sponsored by
George Mason University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sufficient proficiency in spoken English to understand computer-assisted assessments and feedback
  • post-sentencing with a sentence (i.e., less than 12 months) likely to be served out at the jail (vs. a state or federal prison) and likely to be released into the community. The invitation to participate will be timed so treatment is delivered toward the end of incarceration (within one week of release) to minimize decay of effects, and to capitalize on the motivational value of the up-coming release.

Exclusion Criteria:

  • Those with detainers to other jurisdictions and to Immigration and Customs Enforcement (ICE)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Values Affirmation plus Risk Feedback

    Risk Feedback

    Sleep Control

    Arm Description

    Values Affirmation with Risk Feedback in substance use and HIV domains of risk

    Sham Values Affirmation with Risk Feedback in substance use and HIV domains of risk

    Description of sleep habits in lieu of values affirmation/sham values affirmation. No risk feedback

    Outcomes

    Primary Outcome Measures

    Changes in substance use
    Changes in substance use -- among those who were identified at risk and who thus received feedback, pre-post incarceration changes in terms of pre-incarceration standard deviations. If more than one domain of feedback, average standard deviation change.
    Changes in HIV risk behavior
    Changes in HIV risk behavior -- among those who were identified at risk and who thus received feedback, pre-post incarceration changes in terms of pre-incarceration standard deviations. If more than one domain of feedback (risky sex, risky needle use), average standard deviation change.

    Secondary Outcome Measures

    Changes in accuracy of perceptions of normative risk behavior
    Changes in accuracy of perceptions of normative behavior (pre-post intervention changes in terms of pre-intervention standard deviations) in areas of risk/feedback
    Requests Community Resources
    Choose to print a copy of community resources in domain(s) of risk
    Makes Use of Community Resources
    Makes use of relevant community services during 3 months post-release

    Full Information

    First Posted
    March 27, 2018
    Last Updated
    August 6, 2019
    Sponsor
    George Mason University
    Collaborators
    OAR, Fairfax, Slonky, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03501732
    Brief Title
    Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
    Official Title
    Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 27, 2019 (Anticipated)
    Primary Completion Date
    April 1, 2020 (Anticipated)
    Study Completion Date
    August 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    George Mason University
    Collaborators
    OAR, Fairfax, Slonky, Inc

    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
    A key component of effective offender treatment is an initial assessment of risk factors followed by feedback to facilitate problem awareness and engagement in appropriate treatment and/or behavior change. Feedback regarding areas of high risk, however, can be experienced as threatening. The investigators propose to develop, fine-tune, and pilot-test a computerized system for risk assessment and feedback, including evaluation of a brief pre-feedback prosocial values affirmation exercise (Cohen & Sherman, 2014) aimed at decreasing defensiveness and increasing inmates' willingness to access and process risk-relevant information and to utilize post-release treatment resources, thereby reducing post-release substance misuse, HIV risk behavior, and criminal recidivism. Participants will be 170 jail inmates nearing release into the community - 20 pilot participants and 150 study participants randomly assigned to one of three conditions: (1) Values Affirmation + Personalized Risk Feedback; (2) Personalized Risk Feedback only; (3) Control. The baseline and risk assessment, values affirmation manipulation, and personalized risk feedback will be presented via touch-screen computers, requiring minimal training to administer. Analyses will assess: The feasibility of utilizing a computerized system to assess and share risk information with jail inmates, including a brief values affirmation exercise to reduce defensiveness; The acceptability of this approach from the perspectives of jail staff and inmates themselves; The impact of the intervention on observed proximal outcomes (mechanisms of action), such as time spent viewing feedback, electing to print a copy of informational and treatment resources, and consequent changes in perceptions of risk, treatability, etc.; The impact of the intervention on key post-release outcomes including engagement in relevant treatment services, substance misuse, HIV risk behaviors, re-offense and re-arrest; The links between proximal outcomes (MOAs) and key post-release outcomes; Potential moderators of treatment effectiveness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use, HIV Risk Behavior

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Values Affirmation plus Risk Feedback
    Arm Type
    Experimental
    Arm Description
    Values Affirmation with Risk Feedback in substance use and HIV domains of risk
    Arm Title
    Risk Feedback
    Arm Type
    Active Comparator
    Arm Description
    Sham Values Affirmation with Risk Feedback in substance use and HIV domains of risk
    Arm Title
    Sleep Control
    Arm Type
    No Intervention
    Arm Description
    Description of sleep habits in lieu of values affirmation/sham values affirmation. No risk feedback
    Intervention Type
    Behavioral
    Intervention Name(s)
    Values Affirmation
    Intervention Description
    Experimental Group selects two values and describes why they are important
    Intervention Type
    Behavioral
    Intervention Name(s)
    Risk Feedback
    Intervention Description
    Experimental and comparator conditions both receive normative feedback in domains of risk
    Primary Outcome Measure Information:
    Title
    Changes in substance use
    Description
    Changes in substance use -- among those who were identified at risk and who thus received feedback, pre-post incarceration changes in terms of pre-incarceration standard deviations. If more than one domain of feedback, average standard deviation change.
    Time Frame
    3 months post-release (Time 2)
    Title
    Changes in HIV risk behavior
    Description
    Changes in HIV risk behavior -- among those who were identified at risk and who thus received feedback, pre-post incarceration changes in terms of pre-incarceration standard deviations. If more than one domain of feedback (risky sex, risky needle use), average standard deviation change.
    Time Frame
    3 months post-release (Time 2)
    Secondary Outcome Measure Information:
    Title
    Changes in accuracy of perceptions of normative risk behavior
    Description
    Changes in accuracy of perceptions of normative behavior (pre-post intervention changes in terms of pre-intervention standard deviations) in areas of risk/feedback
    Time Frame
    Immediately following intervention (Time 1)
    Title
    Requests Community Resources
    Description
    Choose to print a copy of community resources in domain(s) of risk
    Time Frame
    Immediately following intervention (Time 1)
    Title
    Makes Use of Community Resources
    Description
    Makes use of relevant community services during 3 months post-release
    Time Frame
    3 months post-release (Time 2)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sufficient proficiency in spoken English to understand computer-assisted assessments and feedback post-sentencing with a sentence (i.e., less than 12 months) likely to be served out at the jail (vs. a state or federal prison) and likely to be released into the community. The invitation to participate will be timed so treatment is delivered toward the end of incarceration (within one week of release) to minimize decay of effects, and to capitalize on the motivational value of the up-coming release. Exclusion Criteria: Those with detainers to other jurisdictions and to Immigration and Customs Enforcement (ICE)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    June P Tangney, PhD
    Phone
    7039931365
    Email
    jtangney@gmu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jeffrey Stuewig, PhD
    Phone
    7039931365
    Email
    jstuewig@gmu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    June P Tangney, PhD
    Organizational Affiliation
    George Mason University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    We will make the data and associated documentation available to researchers under a data-sharing agreement that provides for: (1) release of individually prepared datasets containing the subset of variables required to answer the requester's research question(s); (2) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; (3) a commitment to securing the data using appropriate computer technology housed in a secure laboratory facility; and (4) a commitment to destroying or returning the data after analyses are completed. Because of the exceptionally sensitive nature of the data, detailed criminal history and re-arrest information and self-reports of undetected criminal behavior will not be shared. Data requests will be accepted beginning 12 months after publication of the primary findings of the proposed project.
    IPD Sharing Time Frame
    Beginning 12 months after publication of the primary findings of the proposed project, for 5 years.
    IPD Sharing Access Criteria
    Researchers who commit to using the data only for research purposes and not to attempt to identify any individual participant; who commit to securing the data using appropriate computer technology housed in a secure laboratory facility; and who commit to destroying or returning the data after analyses are completed.

    Learn more about this trial

    Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback

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