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临床试验/NCT01482637
NCT01482637已完成不适用

Improving Ethics in Research: Development of the Coercion Assessment Scale

Treatment Research Institute1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
228
试验地点
1
主要终点
Expand Scope of CAS Measure

研究概览

简要总结

In this study, the investigators seek to further develop the CAS as a comprehensive, reliable, and valid instrument for measuring coercion to participate in research among adult substance abusing offender populations.

详细描述

First, the investigators wish to widen the scope of the CAS so that it can reliably and validly measure perceived coercion. The content domain will be expanded to included pressures experienced by a range of individuals involved in the criminal justice system. Second, the investigators will finalize the CAS by ensuring that the instrument is appropriate for use with substance abusing offenders. A final goal of the study examines the psychometric properties of the instrument. This evaluation will include an examination of test-retest reliability, internal consistency and factor structure, and convergent and discriminant validity.

This study will be carried out in three distinct phases to satisfy the goals detailed above. The purpose of Phase 1 is to add to the already existing content of the CAS. In this phase, focus groups will be conducted with clients (i.e., substance abusing offenders) and professionals (i.e., treatment and criminal justice staff and stakeholders) in several different criminal justice. The goal of these groups will be to identify additional sources of coercion that substance abusing offenders may experience related to participation in research. The purpose of Phase 2 is to finalize and ensure the appropriateness of the instrument. In this phase, the investigators will conduct a protocol analysis with 30 drug court clients. The interviewer will read each item aloud to participants, and participants will provide their response. After completing each item, they will be interviewed about how they arrived at their decision. The purpose of Phase 3 is to evaluate the psychometric properties of the CAS. A total of 200 substance abusing offenders participating in an ongoing NIDA-funded study (i.e., the "host study") will receive TRI's manualized written informed consent procedure as part of their participation in the host study. Following consent, research staff will administer study assessments to all consented participants. Additionally, a random sample of 50 clients will be selected to complete a retest interview, scheduled three to five days following the initial interview to assess the extent to which responses vary between the two administrations.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Virtually any defendant admitted to either the misdemeanor drug court of the New Castle County Court of Common Pleas, the 17th Judicial District Drug Court in Union and Snyder Counties, or any research participant in the NITE Study at Miriam Hospital will be eligible to participate.
  • The legal criteria for entry into drug court require defendant to (1) be 18 years of age or older; (2)be a resident of or commit their offense in either New Castle County, Delaware or Union and Snyder Counties, respectively; (3) be charged with a misdemeanor drug offense including possession or consumption of cannabis, possession of drug paraphernalia, possession of hypodermic syringes, or driving under the influence (DUI); and (4) not have a history of a violent offense involving serious injury to a victim or use of a deadly weapon. Individuals with medical or psychiatric conditions will be eligible to participate in the study so long a they are capable of giving competent, informed consent to research participation.

排除标准

  • 未提供

结局指标

主要结局

Expand Scope of CAS Measure

时间窗: Months 9-30

To expand the scope of the CAS so that it can reliably and validly measure perceived coercion to enter research studies in a wide-range of substance abusing offender populations. The content domain will be expanded to include pressures experienced by individuals who have been arrested but not adjudicated (i.e., drug court clients), offenders who have been adjudicated but are not currently incarcerated (i.e., parolees/probationers) and offenders who are currently incarcerated.

Ensuring CAS Use with Substance Abusing Offenders

时间窗: Months 9-30

To finalize the development of the CAS by ensuring that the instrument is appropriate for use with substance abusing offenders. Items on the instrument will be evaluated to ensure that they are correctly worded and that their intended meaning is accurately conveyed to participants.

Evaluate Psychometric Properties of CAS

时间窗: Months 9-30

To evaluate the psychometric properties of the CAS to ensure that it is a reliable and valid measure of perceived coercion to participate in research. The psychometric evaluation will include an examination of test-retest reliability, internal consistency and factor structure, and convergent and discriminant validity.

次要结局

未报告次要终点

研究者

发起方
Treatment Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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Development of Coercion Assessment Scale | 临床试验