Substance Abuse Problem
Conditions
Keywords
gender-responsive substance abuse treatment
Brief 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).
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.
Interventions
BEHAVIORALWomen-Only
Gender-responsive treatment for women only
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Predictors of Criminal Activity at 12 Months Post Intake | 12 Months | — |
| Any Substance Use Past 30 Days | 12 Months | Substance use in past 30 days at 12 months post intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model | 12 month post intake | Predictors of change in employment at 12 months post intake: GEE - comparison of Women-Only vs. Mixed-Gender treatment models |
Countries
United States
Participant flow
Recruitment details
425 Potential subjects approached at community drug treatment clinics and drug courts 291 Completed baseline intake interview
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Women-Only Treatment 152 Subjects Out-patient gender-responsive substance abuse treatment for women only | 152 |
| Mixed-Gender Treatment 139 Subjects Out-patient substance abuse treatment for women and men | 139 |
| Total | 291 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month Follow-up | Death | 1 | 1 |
| 12 Month Follow-up | Lost to Follow-up | 10 | 8 |
| 12 Month Follow-up | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | Women-Only Treatment 152 Subjects | Mixed-Gender Treatment 139 Subjects | Total |
|---|---|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 10.1 | 36.5 years STANDARD_DEVIATION 10.2 | 35.7 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 152 participants | 139 participants | 291 participants |
| Sex: Female, Male Female | 152 Participants | 139 Participants | 291 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 152 | 0 / 139 |
| serious Total, serious adverse events | 0 / 152 | 0 / 139 |
Outcome results
Primary
Any Substance Use Past 30 Days
Substance use in past 30 days at 12 months post intake
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women-Only | Any Substance Use Past 30 Days | 0.42 Odds ratio |
Comparison: Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.p-value: 0.0195% CI: [0.22, 0.82]Regression, Logistic
Primary
Predictors of Criminal Activity at 12 Months Post Intake
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women-Only | Predictors of Criminal Activity at 12 Months Post Intake | 0.40 Odds ratio |
Comparison: Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.p-value: 0.0195% CI: [0.21, 0.79]Regression, Logistic
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
Time frame: baseline and 1-year follow-up
Population: Intention to treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women-Only | 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 |
| Women-Only | 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 |
| Mixed-Gender | 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 | 76.9 Percentage reporting criminal activity |
| Mixed-Gender | 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 | 39.7 Percentage reporting criminal activity |
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
Time frame: 12 month post intake
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women-Only | Predictors of Change in Employment at 12 Months Post Intake: Generalized Estimating Equation (GEE) Model | -0.70 Beta coefficient |
Comparison: Generalized estimating equation (GEE) models do not separate arms: group status (women-only vs mixed-gender) is the dependent variable. Because we were not able to randomly assign, we also included a propensity score, and additional variables (education, race/ethnicity, marital status, income, history of sexual abuse, criminal justice funding source, had child, mental health symptoms, and a time in treatment by group interaction term) to adjust for the non-random sampling.p-value: 0.3395% CI: [-2.11, 0.7]Generalized estimating equations (GEE)