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
About this trial
This is an interventional treatment trial for Substance Use
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)
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
NCT ID
NCT03501732
First Posted
March 27, 2018
Last Updated
August 6, 2019
Sponsor
George Mason University
Collaborators
OAR, Fairfax, Slonky, Inc
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
We'll reach out to this number within 24 hrs