Substance Abuse ProblemNCT00249613
Gender-Responsive Treatment for Women Offenders - 1
A study testing Women-Only in people with Substance Abuse Problem, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse Problem
- What is being tested?
- Women-Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not capable of giving informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California - Los Angeles
Los Angeles, California, 90024
About this study
Official title: 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).
Read the 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.
- Conditions
- Substance Abuse Problem
- Being tested
- Women-Only
- Keywords
- gender-responsive substance abuse treatment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women-OnlyBehavioural
Gender-responsive treatment for women only
| Study group | Role | What they receive |
|---|---|---|
| Women-Only | Experimental | Substance abuse treatment program for women only Receives: Behavioral: Women-Only |
| Mixed-Gender | No intervention | Substance abuse treatment program for both women and men |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results (Unadjusted) for Criminal Activities in Past 30 Days at Baseline and Follow-up for Women in Women-Only Treatment and Mixed-Gender Treatment
Measured: baseline and 1-year follow-up
Predictors of Criminal Activity at 12 Months Post Intake
Measured: 12 Months
Any Substance Use Past 30 Days
Substance use in past 30 days at 12 months post intake
Measured: 12 Months
Secondary outcomes (1)
Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model
Predictors of change in employment at 12 months post intake: GEE - comparison of Women-Only vs. Mixed-Gender treatment models
Measured: 12 month post intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startJun 2005
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Abuse ProblemStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael Prendergast, University of California, Los Angeles
- Investigators
- Michael Prendergast, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249613
- Sponsor's protocol ID
- NIDA-16277-1
- Other IDs
- R01DA016277
- Status last verified
- Mar 2014
- First submitted
- 3 Nov 2005
- Last updated
- 7 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Prendergast ML, Messina NP, Hall EA, Warda US. The relative effectiveness of women-only and mixed-gender treatment for substance-abusing women. J Subst Abuse Treat. 2011 Jun;40(4):336-48. doi: 10.1016/j.jsat.2010.12.001. Epub 2011 Feb 11.
PubMed 21315540
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender-Responsive Treatment for Women Offenders
- ClinicalTrials.gov ID
- NCT00249613
- Acronym / sponsor ID
- NIDA-16277-1
- Conditions
- Substance Abuse Problem
- Keywords
- gender-responsive substance abuse treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women-Only | Experimental | Behavioral: Women-OnlySubstance abuse treatment program for women only |
| Mixed-Gender | No intervention | –Substance abuse treatment program for both women and men |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not capable of giving informed consent
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 |
|---|---|---|
| Women-OnlyGender-responsive treatment for women only | Behavioural | Women-Only |
Primary outcome
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
Predictors of Criminal Activity at 12 Months Post Intake
Time frame: 12 Months
Any Substance Use Past 30 Days
Time frame: 12 Months
Substance use in past 30 days at 12 months post intake
1 secondary outcome
Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model
Time frame: 12 month post intake
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21315540Prendergast ML, Messina NP, Hall EA, Warda US. The relative effectiveness of women-only and mixed-gender treatment for substance-abusing women. J Subst Abuse Treat. 2011 Jun;40(4):336-48. doi: 10.1016/j.jsat.2010.12.001. Epub 2011 Feb 11.
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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.
Michael Prendergast, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Women-Only in people with Substance Abuse Problem, run by University of California, Los Angeles 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 4 inclusion and 1 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 7 Apr 2014. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). 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?
On the ClinicalTrials.gov record for NCT00249613, which also lists 1 linked publication.
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 7 Apr 2014; AzTrials last refreshed its copy on 7 Nov 2026.