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Trial record 9 of 34209 for:    value

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

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

Tracking Information
First Submitted Date  ICMJE March 27, 2018
First Posted Date  ICMJE April 18, 2018
Last Update Posted Date August 8, 2019
Estimated Study Start Date  ICMJE August 27, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03501732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • 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
  • Requests Community Resources [ Time Frame: Immediately following intervention (Time 1) ]
    Choose to print a copy of community resources in domain(s) of risk
  • Makes Use of Community Resources [ Time Frame: 3 months post-release (Time 2) ]
    Makes use of relevant community services during 3 months post-release
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
Official Title  ICMJE Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Substance Use
  • HIV Risk Behavior
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Values Affirmation plus Risk Feedback
    Values Affirmation with Risk Feedback in substance use and HIV domains of risk
    Interventions:
    • Behavioral: Values Affirmation
    • Behavioral: Risk Feedback
  • Active Comparator: Risk Feedback
    Sham Values Affirmation with Risk Feedback in substance use and HIV domains of risk
    Intervention: Behavioral: Risk Feedback
  • No Intervention: Sleep Control
    Description of sleep habits in lieu of values affirmation/sham values affirmation. No risk feedback
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: June P Tangney, PhD 7039931365 jtangney@gmu.edu
Contact: Jeffrey Stuewig, PhD 7039931365 jstuewig@gmu.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03501732
Other Study ID Numbers  ICMJE R34DA042974-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party June Tangney, George Mason University
Study Sponsor  ICMJE George Mason University
Collaborators  ICMJE
  • OAR, Fairfax
  • Slonky, Inc
Investigators  ICMJE
Principal Investigator: June P Tangney, PhD George Mason University
PRS Account George Mason University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP