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

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03501732
• Other study ID #: R34DA042974-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2019
• Source: George Mason University
• Contact: June P Tangney, PhD
• Phone: 7039931365
• Email: jtangney[@]gmu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV Risk Behavior
• Substance Use

Intervention

Behavioral:
• Values Affirmation
Experimental Group selects two values and describes why they are important
• Risk Feedback
Experimental and comparator conditions both receive normative feedback in domains of risk

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
George Mason University	OAR, Fairfax, Slonky, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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	Immediately following intervention (Time 1)
Secondary	Requests Community Resources	Choose to print a copy of community resources in domain(s) of risk	Immediately following intervention (Time 1)
Secondary	Makes Use of Community Resources	Makes use of relevant community services during 3 months post-release	3 months post-release (Time 2)