Development of Coercion Assessment Scale (CAS)

This study is currently recruiting participants.
Verified July 2013 by Treatment Research Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Treatment Research Institute
ClinicalTrials.gov Identifier:
NCT01482637
First received: November 28, 2011
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Coercion to Participate in Research
Other: CAS
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Improving Ethics in Research: Development of the Coercion Assessment Scale

Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:
  • Expand Scope of CAS Measure [ Time Frame: Months 9-30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Months 9-30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Months 9-30 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CAS
There are no separate groups. All subjects are being asked to complete the CAS measure.
Other: CAS
All clients will be asked to complete the CAS instrument.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

For Phase 3, a total of 200 clients will be drawn from the host study recruiting from a misdemeanor drug court in New Castle County, Delaware. In our most recent study in this same program, gender and racial minority representation was excellent and was reflective of the target drug court population in New Castle County with approximately 50% Caucasian, 40% African-American, and 10% Hispanic or Latino. Similarly, the investigators had excellent representation of female drug court clients. Nearly half (46%) of our participants were between the ages of 18 and 21 years. The investigators expect the sample for the current study to have a similar composition.

Criteria

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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482637

Contacts
Contact: Karen Dugosh, Ph.D. 215-399-0980 ext 104 kdugosh@tresearch.org

Locations
United States, Pennsylvania
Treatment Research Institute Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Karen Dugosh, Ph.D    215-399-0980 ext 104    kdugosh@tresearch.org   
Principal Investigator: Karen Dugosh, Ph.D.         
Sponsors and Collaborators
Treatment Research Institute
Investigators
Principal Investigator: Karen Dugosh, Ph.D. Treatment Research Institute
  More Information

No publications provided

Responsible Party: Treatment Research Institute
ClinicalTrials.gov Identifier: NCT01482637     History of Changes
Other Study ID Numbers: #0902, R01DA025687
Study First Received: November 28, 2011
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014