- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00249613
Gender-Responsive Treatment for Women Offenders - 1
March 7, 2014 updated by: Michael Prendergast, University of California, Los Angeles
Gender-Responsive Treatment for Women Offenders
The purpose of this study is to determine whether substance abuse treatment designed specifically for drug-dependent women offenders provides better outcomes than standard drug court treatment (mixed-gender programs).
Study Overview
Detailed Description
In this five-year study, a total of 300 women entering court-referred treatment throughout Los Angeles County and who agree to participate in the study will be randomly assigned to a women-focused or to a mixed-gender outpatient treatment program.
The study will assess the impact of women-focused substance abuse treatment using outcome measures including recidivism, substance abuse and relapse, and social adjustment (e.g., employment, parenting behaviors, psychological improvement, and HIV risk reduction behaviors), compared to the impact of traditional mixed-gender programs.
Assessments will occur at baseline and at 1 month, 12 months, and 24 months after admission.
Study Type
Interventional
Enrollment (Actual)
291
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90024
- University of California - Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Drug court participant
- At least eighteen (18) years old
- Have had no more than three prior non-violent, non-drug felony convictions
- Do not have a current charge of driving under the influence of alcohol or drugs or a charge of sale or transportation of drugs
Exclusion Criteria:
- Not capable of giving informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Women-Only
Substance abuse treatment program for women only
|
Gender-responsive treatment for women only
|
No Intervention: Mixed-Gender
Substance abuse treatment program for both women and men
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Results (Unadjusted) for Criminal Activities in Past 30 Days at Baseline and Follow-up for Women in Women-Only Treatment and Mixed-Gender Treatment
Time Frame: baseline and 1-year follow-up
|
baseline and 1-year follow-up
|
|
Predictors of Criminal Activity at 12 Months Post Intake
Time Frame: 12 Months
|
12 Months
|
|
Any Substance Use Past 30 Days
Time Frame: 12 Months
|
Substance use in past 30 days at 12 months post intake
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model
Time Frame: 12 month post intake
|
Predictors of change in employment at 12 months post intake: GEE - comparison of Women-Only vs. Mixed-Gender treatment models
|
12 month post intake
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Prendergast, Ph.D., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
January 1, 2009
Study Registration Dates
First Submitted
November 3, 2005
First Submitted That Met QC Criteria
November 3, 2005
First Posted (Estimate)
November 7, 2005
Study Record Updates
Last Update Posted (Estimate)
April 7, 2014
Last Update Submitted That Met QC Criteria
March 7, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-16277-1
- R01DA016277 (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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