Coercion to Participate in ResearchCASNCT01482637
Development of Coercion Assessment Scale
An observational study of Coercion to Participate in Research, run by Treatment Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coercion to Participate in Research
- What is being tested?
- CAS
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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."
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Treatment Research Institute
Philadelphia, Pennsylvania, 19106
About this study
Official title: Improving Ethics in Research: Development of the Coercion Assessment Scale
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.
Read the 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.
- Conditions
- Coercion to Participate in Research
- Being tested
- CAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CASOther
All clients will be asked to complete the CAS instrument.
| Study group | Role | What they receive |
|---|---|---|
| CAS | There are no separate groups. All subjects are being asked to complete the CAS measure. Receives: Other: CAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Months 9-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coercion to Participate in ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Karen Dugosh, Ph.D., Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482637
- Sponsor's protocol ID
- #0902
- Other IDs
- R01DA025687
- Acronym
- CAS
- Status last verified
- Mar 2023
- First submitted
- 28 Nov 2011
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Ethics in Research: Development of the Coercion Assessment Scale
- ClinicalTrials.gov ID
- NCT01482637
- Acronym / sponsor ID
- CAS / #0902
- Conditions
- Coercion to Participate in Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAS | – | Other: CASThere are no separate groups. All subjects are being asked to complete the CAS measure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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."
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CASAll clients will be asked to complete the CAS instrument. | Other | CAS |
Primary outcome
Expand Scope of CAS Measure
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Dugosh, Ph.D. principal investigator
Treatment Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coercion to Participate in Research, run by Treatment Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expand Scope of CAS Measure (time frame: Months 9-30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.