- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01482637
Development of Coercion Assessment Scale (CAS)
Improving Ethics in Research: Development of the Coercion Assessment Scale
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
- Treatment Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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CAS
There are no separate groups.
All subjects are being asked to complete the CAS measure.
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All clients will be asked to complete the CAS instrument.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Expand Scope of CAS Measure
Time Frame: Months 9-30
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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.
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Months 9-30
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Ensuring CAS Use with Substance Abusing Offenders
Time Frame: Months 9-30
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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.
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Months 9-30
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Evaluate Psychometric Properties of CAS
Time Frame: Months 9-30
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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.
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Months 9-30
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen Dugosh, Ph.D., Treatment Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- #0902
- R01DA025687 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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