NCT01482637

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

November 28, 2011

Last Update Submit

March 27, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Expand Scope of CAS Measure

    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.

    Months 9-30

  • Ensuring CAS Use with Substance Abusing Offenders

    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.

    Months 9-30

  • Evaluate Psychometric Properties of CAS

    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.

    Months 9-30

Study Arms (1)

CAS

There are no separate groups. All subjects are being asked to complete the CAS measure.

Other: CAS

Interventions

CASOTHER

All clients will be asked to complete the CAS instrument.

CAS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

For Phase 3, a total of 228 clients were drawn from the host study recruiting from a misdemeanor drug court in New Castle County, Delaware and from Miriam Prison in Rhode Island. The sample is representative of the combined demographic characteristics of our host studies with the study participants being 75% male, 75% Caucasian, and 22% African-American in the Wilmington and Rhode Island sites. Our sample of adolescents is representative of the host study with 78% African-American, 8% Caucasian and 13% "Other."

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treatment Research Institute

Philadelphia, Pennsylvania, 19106, United States

Location

Study Officials

  • Karen Dugosh, Ph.D.

    Treatment Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

November 30, 2011

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations