Substance UseNCT03501732
Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
A study testing Values Affirmation and Risk Feedback in people with Substance Use and HIV Risk Behavior, run by George Mason University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use, HIV Risk Behavior
- What is being tested?
- Values Affirmation and Risk Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2019to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those with detainers to other jurisdictions and to Immigration and Customs Enforcement (ICE)
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Substance Use, HIV Risk Behavior
- Being tested
- Values Affirmation, Risk Feedback
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Values AffirmationBehavioural
Experimental Group selects two values and describes why they are important
Risk FeedbackBehavioural
Experimental and comparator conditions both receive normative feedback in domains of risk
| Study group | Role | What they receive |
|---|---|---|
| Values Affirmation plus Risk Feedback | Experimental | Values Affirmation with Risk Feedback in substance use and HIV domains of risk Receives: Behavioral: Values Affirmation; Behavioral: Risk Feedback |
| Risk Feedback | Active comparator | Sham Values Affirmation with Risk Feedback in substance use and HIV domains of risk Receives: Behavioral: Risk Feedback |
| Sleep Control | No intervention | Description of sleep habits in lieu of values affirmation/sham values affirmation. No risk feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months post-release (Time 2)
Secondary outcomes (3)
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
Measured: Immediately following intervention (Time 1)
Requests Community Resources
Choose to print a copy of community resources in domain(s) of risk
Measured: Immediately following intervention (Time 1)
Makes Use of Community Resources
Makes use of relevant community services during 3 months post-release
Measured: 3 months post-release (Time 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start27 Aug 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Mason University
- Sponsor type
- University, hospital or other
- Collaborators
- OAR, Fairfax, Slonky, Inc
- Responsible party
- Principal investigator, June Tangney, George Mason University
- Investigators
- June P Tangney, PhD, Principal investigator, George Mason University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501732
- Sponsor's protocol ID
- R34DA042974-01
- Status last verified
- Aug 2019
- First submitted
- 27 Mar 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
- ClinicalTrials.gov ID
- NCT03501732
- Acronym / sponsor ID
- R34DA042974-01
- Conditions
- Substance Use, HIV Risk Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- George Mason UniversityUniversity, hospital or other
- Collaborators
- OAR, Fairfax, Slonky, Inc
- Study start
- 27 Aug 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Values Affirmation plus Risk Feedback | Experimental | Behavioral: Values Affirmation, Behavioral: Risk FeedbackValues Affirmation with Risk Feedback in substance use and HIV domains of risk |
| Risk Feedback | Active comparator | Behavioral: Risk FeedbackSham Values Affirmation with Risk Feedback in substance use and HIV domains of risk |
| Sleep Control | No intervention | –Description of sleep habits in lieu of values affirmation/sham values affirmation. No risk feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Those with detainers to other jurisdictions and to Immigration and Customs Enforcement (ICE)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Values AffirmationExperimental Group selects two values and describes why they are important | Behavioural | Values Affirmation plus Risk Feedback |
| Risk FeedbackExperimental and comparator conditions both receive normative feedback in domains of risk | Behavioural | Risk Feedback, Values Affirmation plus Risk Feedback |
Primary outcome
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.
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.
3 secondary outcomes
Changes in accuracy of perceptions of normative risk behavior
Time frame: Immediately following intervention (Time 1)
Requests Community Resources
Time frame: Immediately following intervention (Time 1)
Makes Use of Community Resources
Time frame: 3 months post-release (Time 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June P Tangney, PhD principal investigator
George Mason University
Questions about this trial
What is this clinical trial studying?
A study testing Values Affirmation and Risk Feedback in people with Substance Use and HIV Risk Behavior, run by George Mason University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact June P Tangney, PhD (7039931365, jtangney@gmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in substance use (time frame: 3 months post-release (Time 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.