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

• ClinicalTrials.gov Identifier: NCT03501732
• Recruitment Status: Not yet recruiting
• First Posted: April 18, 2018
• Last Update Posted: August 8, 2019
• Sponsor: George Mason University
• Collaborators: OAR, Fairfax; Slonky, Inc
• Information provided by (Responsible Party): June Tangney, George Mason University

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:

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.

Condition or disease	Intervention/treatment	Phase
Substance Use; HIV Risk Behavior	Behavioral: Values Affirmation; Behavioral: Risk Feedback	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
• Estimated Study Start Date: August 27, 2019
• Estimated Primary Completion Date: April 1, 2020
• Estimated Study Completion Date: August 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Values Affirmation plus Risk Feedback; Values Affirmation with Risk Feedback in substance use and HIV domains of risk	Behavioral: Values Affirmation; Experimental Group selects two values and describes why they are important; Behavioral: Risk Feedback; Experimental and comparator conditions both receive normative feedback in domains of risk
Active Comparator: Risk Feedback; Sham Values Affirmation with Risk Feedback in substance use and HIV domains of risk	Behavioral: Risk Feedback; Experimental and comparator conditions both receive normative feedback in domains of risk
No Intervention: Sleep Control; Description of sleep habits in lieu of values affirmation/sham values affirmation. No risk feedback

Outcome Measures

Primary Outcome Measures :

1. Changes in substance use [ Time Frame: 3 months post-release (Time 2) ]
   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.
2. Changes in HIV risk behavior [ Time Frame: 3 months post-release (Time 2) ]
   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 :

1. Changes in accuracy of perceptions of normative risk behavior [ Time Frame: Immediately following intervention (Time 1) ]
   Changes in accuracy of perceptions of normative behavior (pre-post intervention changes in terms of pre-intervention standard deviations) in areas of risk/feedback
2. Requests Community Resources [ Time Frame: Immediately following intervention (Time 1) ]
   Choose to print a copy of community resources in domain(s) of risk
3. Makes Use of Community Resources [ Time Frame: 3 months post-release (Time 2) ]
   Makes use of relevant community services during 3 months post-release

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: June P Tangney, PhD; 7039931365; jtangney@gmu.edu

Contact: Jeffrey Stuewig, PhD; 7039931365; jstuewig@gmu.edu

Sponsors and Collaborators

George Mason University

OAR, Fairfax

Slonky, Inc

Investigators

• Principal Investigator: June P Tangney, PhD; George Mason University

More Information

• Responsible Party: June Tangney, Professor, George Mason University
• ClinicalTrials.gov Identifier: NCT03501732 History of Changes
• Other Study ID Numbers: R34DA042974-01 ( U.S. NIH Grant/Contract )
• First Posted: April 18, 2018
• Last Update Posted: August 8, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No