Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
6 augustus 2019 bijgewerkt door: June Tangney, George Mason University
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
150
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Values Affirmation plus Risk Feedback
Values Affirmation with Risk Feedback in substance use and HIV domains of risk
|
Experimental Group selects two values and describes why they are important
Experimental and comparator conditions both receive normative feedback in domains of risk
|
|
Actieve vergelijker: Risk Feedback
Sham Values Affirmation with Risk Feedback in substance use and HIV domains of risk
|
Experimental and comparator conditions both receive normative feedback in domains of risk
|
|
Geen tussenkomst: Sleep Control
Description of sleep habits in lieu of values affirmation/sham values affirmation.
No risk feedback
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in substance use
Tijdsspanne: 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.
|
3 months post-release (Time 2)
|
|
Changes in HIV risk behavior
Tijdsspanne: 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 months post-release (Time 2)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in accuracy of perceptions of normative risk behavior
Tijdsspanne: 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
|
Immediately following intervention (Time 1)
|
|
Requests Community Resources
Tijdsspanne: Immediately following intervention (Time 1)
|
Choose to print a copy of community resources in domain(s) of risk
|
Immediately following intervention (Time 1)
|
|
Makes Use of Community Resources
Tijdsspanne: 3 months post-release (Time 2)
|
Makes use of relevant community services during 3 months post-release
|
3 months post-release (Time 2)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: June P Tangney, PhD, George Mason University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
27 augustus 2019
Primaire voltooiing (Verwacht)
1 april 2020
Studie voltooiing (Verwacht)
1 augustus 2020
Studieregistratiedata
Eerst ingediend
27 maart 2018
Eerst ingediend dat voldeed aan de QC-criteria
10 april 2018
Eerst geplaatst (Werkelijk)
18 april 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 augustus 2019
Laatste update ingediend die voldeed aan QC-criteria
6 augustus 2019
Laatst geverifieerd
1 augustus 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R34DA042974-01 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
Beginning 12 months after publication of the primary findings of the proposed project, for 5 years.
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .