Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
1 other identifier
interventional
150
0 countries
N/A
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:
- 1.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;
- 2.The acceptability of this approach from the perspectives of jail staff and inmates themselves;
- 3.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.;
- 4.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;
- 5.The links between proximal outcomes (MOAs) and key post-release outcomes;
- 6.Potential moderators of treatment effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
August 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedAugust 8, 2019
August 1, 2019
7 months
March 27, 2018
August 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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.
3 months post-release (Time 2)
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.
3 months post-release (Time 2)
Secondary Outcomes (3)
Changes in accuracy of perceptions of normative risk behavior
Immediately following intervention (Time 1)
Requests Community Resources
Immediately following intervention (Time 1)
Makes Use of Community Resources
3 months post-release (Time 2)
Study Arms (3)
Values Affirmation plus Risk Feedback
EXPERIMENTALValues Affirmation with Risk Feedback in substance use and HIV domains of risk
Risk Feedback
ACTIVE COMPARATORSham Values Affirmation with Risk Feedback in substance use and HIV domains of risk
Sleep Control
NO INTERVENTIONDescription of sleep habits in lieu of values affirmation/sham values affirmation. No risk feedback
Interventions
Experimental Group selects two values and describes why they are important
Experimental and comparator conditions both receive normative feedback in domains of risk
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Those with detainers to other jurisdictions and to Immigration and Customs Enforcement (ICE)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- George Mason Universitylead
- OAR, Fairfaxcollaborator
- Slonky, Inccollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
June P Tangney, PhD
George Mason University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 18, 2018
Study Start
August 27, 2019
Primary Completion
April 1, 2020
Study Completion
August 1, 2020
Last Updated
August 8, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Beginning 12 months after publication of the primary findings of the proposed project, for 5 years.
- 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.
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.