Trial Outcomes & Findings for Gender-Responsive Treatment for Women Offenders - 1 (NCT NCT00249613)
NCT ID: NCT00249613
Last Updated: 2014-04-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
291 participants
Primary outcome timeframe
baseline and 1-year follow-up
Results posted on
2014-04-07
Participant Flow
425 Potential subjects approached at community drug treatment clinics and drug courts 291 Completed baseline intake interview
At baseline, we had 51 Refusals, 30 Ineligible for study 27 No show to baseline interview, and 26 who did not complete baseline intake interview.
Participant milestones
| Measure |
Women-Only Treatment 152 Subjects
Out patient gender-responsive substance abuse treatment for women only
|
Mixed-Gender Treatment 139 Subjects
Out-patient substance abuse treatment that included both women and men
|
|---|---|---|
|
Baseline
STARTED
|
152
|
139
|
|
Baseline
COMPLETED
|
152
|
139
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
12 Month Follow-up
STARTED
|
152
|
139
|
|
12 Month Follow-up
COMPLETED
|
135
|
124
|
|
12 Month Follow-up
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
Women-Only Treatment 152 Subjects
Out patient gender-responsive substance abuse treatment for women only
|
Mixed-Gender Treatment 139 Subjects
Out-patient substance abuse treatment that included both women and men
|
|---|---|---|
|
12 Month Follow-up
Death
|
1
|
1
|
|
12 Month Follow-up
Withdrawal by Subject
|
6
|
6
|
|
12 Month Follow-up
Lost to Follow-up
|
10
|
8
|
Baseline Characteristics
Gender-Responsive Treatment for Women Offenders - 1
Baseline characteristics by cohort
| Measure |
Women-Only Treatment 152 Subjects
n=152 Participants
Out-patient gender-responsive substance abuse treatment for women only
|
Mixed-Gender Treatment 139 Subjects
n=139 Participants
Out-patient substance abuse treatment for women and men
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=5 Participants
|
139 participants
n=7 Participants
|
291 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 1-year follow-upPopulation: Intention to treat (ITT)
Outcome measures
| Measure |
Women-Only
n=152 Participants
Substance abuse treatment program for women only
Women-Only: Gender-responsive treatment for women only
|
Mixed-Gender
n=139 Participants
Substance abuse treatment program for both women and men
|
|---|---|---|
|
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
|
63.9 Percentage reporting criminal activity
|
76.9 Percentage reporting criminal activity
|
|
Results (Unadjusted) for Criminal Activities in Past 30 Days at Baseline and Follow-up for Women in Women-Only Treatment and Mixed-Gender Treatment
1 Year Follow-up
|
22.3 Percentage reporting criminal activity
|
39.7 Percentage reporting criminal activity
|
PRIMARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Women-Only
n=259 Participants
Substance abuse treatment program for women only
Women-Only: Gender-responsive treatment for women only
|
Mixed-Gender
Substance abuse treatment program for both women and men
|
|---|---|---|
|
Predictors of Criminal Activity at 12 Months Post Intake
|
0.40 Odds ratio
Interval 0.21 to 0.79
|
—
|
PRIMARY outcome
Timeframe: 12 MonthsSubstance use in past 30 days at 12 months post intake
Outcome measures
| Measure |
Women-Only
n=291 Participants
Substance abuse treatment program for women only
Women-Only: Gender-responsive treatment for women only
|
Mixed-Gender
Substance abuse treatment program for both women and men
|
|---|---|---|
|
Any Substance Use Past 30 Days
|
0.42 Odds ratio
Interval 0.22 to 0.82
|
—
|
SECONDARY outcome
Timeframe: 12 month post intakePredictors of change in employment at 12 months post intake: GEE - comparison of Women-Only vs. Mixed-Gender treatment models
Outcome measures
| Measure |
Women-Only
n=291 Participants
Substance abuse treatment program for women only
Women-Only: Gender-responsive treatment for women only
|
Mixed-Gender
Substance abuse treatment program for both women and men
|
|---|---|---|
|
Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model
|
-0.70 Beta coefficient
Interval -2.11 to 0.7
|
—
|
Adverse Events
Women-Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mixed-Gender
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Prendergast
UCLA Integrated Substance Abuse Programs
Phone: 310-267-5503
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place