CClinicalTrials.gg
Status unknownNCT03501732Updated Aug 8, 2019

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

An interventional study of Values Affirmation and Risk Feedback in Substance Use and HIV Risk Behavior, sponsored by George Mason University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by George Mason University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.
02

Conditions studied

  • Substance Use
  • HIV Risk Behavior
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 150 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

George Mason University is the lead sponsor of 41 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Those with detainers to other jurisdictions and to Immigration and Customs Enforcement (ICE)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Values Affirmation plus Risk Feedback

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

    Behavioral: Values Affirmation · Behavioral: Risk Feedback

  • Active comparator
    Risk Feedback

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

    Behavioral: Risk Feedback

  • No intervention
    Sleep Control

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

Interventions

  • BehavioralValues Affirmation

    Experimental Group selects two values and describes why they are important

  • BehavioralRisk Feedback

    Experimental and comparator conditions both receive normative feedback in domains of risk

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months post-release (Time 2)

  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.

    Time frame: 3 months post-release (Time 2)

Secondary outcomes

  1. 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

    Time frame: Immediately following intervention (Time 1)

  2. Requests Community Resources

    Choose to print a copy of community resources in domain(s) of risk

    Time frame: Immediately following intervention (Time 1)

  3. Makes Use of Community Resources

    Makes use of relevant community services during 3 months post-release

    Time frame: 3 months post-release (Time 2)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03501732
Lead sponsor
George Mason University
Collaborators
OAR, Fairfax, Slonky, Inc
Responsible party
June Tangney (Professor, George Mason University) — Principal investigator
First posted
Apr 18, 2018
Start date
Aug 27, 2019 (estimated)
Primary completion
Apr 1, 2020 (estimated)
Completion
Aug 1, 2020 (estimated)
Last update
Aug 8, 2019

Study contacts

June P Tangney, PhD
Contact
jtangney@gmu.edu
7039931365
Jeffrey Stuewig, PhD
Contact
jstuewig@gmu.edu
7039931365
June P Tangney, PhD
principal investigator · George Mason University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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