Using Values to Enhance Inmates' Response to Substance Use and HIV Risk Feedback
2019年8月6日 更新者：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.
調査の概要
研究の種類
介入
入学 (予想される)
150
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
アクティブコンパレータ：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
|
|
介入なし：Sleep Control
Description of sleep habits in lieu of values affirmation/sham values affirmation.
No risk feedback
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in substance use
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in accuracy of perceptions of normative risk behavior
時間枠：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
時間枠：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
時間枠：3 months post-release (Time 2)
|
Makes use of relevant community services during 3 months post-release
|
3 months post-release (Time 2)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：June P Tangney, PhD、George Mason University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2019年8月27日
一次修了 (予想される)
2020年4月1日
研究の完了 (予想される)
2020年8月1日
試験登録日
最初に提出
2018年3月27日
QC基準を満たした最初の提出物
2018年4月10日
最初の投稿 (実際)
2018年4月18日
学習記録の更新
投稿された最後の更新 (実際)
2019年8月8日
QC基準を満たした最後の更新が送信されました
2019年8月6日
最終確認日
2019年8月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Beginning 12 months after publication of the primary findings of the proposed project, for 5 years.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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