Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
6. august 2019 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
150
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Aktiv komparator: 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
|
|
Ingen indgriben: Sleep Control
Description of sleep habits in lieu of values affirmation/sham values affirmation.
No risk feedback
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in substance use
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in accuracy of perceptions of normative risk behavior
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months post-release (Time 2)
|
Makes use of relevant community services during 3 months post-release
|
3 months post-release (Time 2)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: June P Tangney, PhD, George Mason University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
27. august 2019
Primær færdiggørelse (Forventet)
1. april 2020
Studieafslutning (Forventet)
1. august 2020
Datoer for studieregistrering
Først indsendt
27. marts 2018
Først indsendt, der opfyldte QC-kriterier
10. april 2018
Først opslået (Faktiske)
18. april 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. august 2019
Sidst verificeret
1. august 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R34DA042974-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
Beginning 12 months after publication of the primary findings of the proposed project, for 5 years.
IPD-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .