Gender-Responsive Treatment for Women Offenders - 1

Substance Abuse Problem Clinical Trial

Official title:

Gender-Responsive Treatment for Women Offenders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249613
• Other study ID #: NIDA-16277-1
• Secondary ID: R01DA016277
• Status: Completed
• Phase: N/A
• First received: November 3, 2005
• Last updated: March 7, 2014
• Start date: June 2005
• Est. completion date: January 2009

Study information

• Verified date: March 2014
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Abuse Problem
• Substance-Related Disorders

Intervention

Behavioral:
• Women-Only
Gender-responsive treatment for women only

Locations

Country	Name	City	State
United States	University of California - Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results (Unadjusted) for Criminal Activities in Past 30 Days at Baseline and Follow-up for Women in Women-Only Treatment and Mixed-Gender Treatment		baseline and 1-year follow-up	No
Primary	Predictors of Criminal Activity at 12 Months Post Intake		12 Months	No
Primary	Any Substance Use Past 30 Days	Substance use in past 30 days at 12 months post intake	12 Months	No
Secondary	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	12 month post intake	No