UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94131, United States
NCT Number: NCT02293057
Girls in the juvenile justice system have unique developmental pathways to drug use and co-occurring risk (e.g., HIV/STI) behaviors that have typically not been considered or tested in order to identify evidence-based gender-specific substance use treatment approaches for this population. This study will advance scientific knowledge and clinical practice in the drug treatment and public health fields by testing the efficacy of a pre-existing, widely disseminated gender-responsive substance use treatment (VOICES) on drug use and HIV/STI risk behavior outcomes for a broad range of substance using girls and young women (ages 12-24) who are at-risk for or already involved with the justice system.
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Notify Me12 year–24 year
Female
Interventional
Not applicable
San Francisco, California, 94131, United States
Compared to both non-offending females and male offending counterparts, offending girls are at significantly greater risk for the development of substance use disorders, psychiatric symptoms and negative health outcomes, such as HIV/AIDS or other sexually transmitted infections (STIs). Research suggests that girls may have different developmental pathways to drug use, initial legal involvement and co-occurring negative health outcomes that support the importance of testing gender-specific treatments for juvenile justice girls. Although there is recent increased emphasis on gender-specific programming in juvenile justice, empirically supported gender specific interventions to improve health, mental health and/or legal outcomes among juvenile justice girls are lacking. The objective of this Stage II treatment trial is therefore to test the efficacy of a pre-existing, widely disseminated gender-responsive drug use treatment (VOICES) among 130 girls who are at-risk for or already involved with the justice system. We seek to test the effect of VOICES on girls' drug and alcohol use, HIV/STI risk, psychiatric symptoms and recidivism as well as explore moderators and mediators of outcomes. Girls and young women, ages 12-24 (N= 6 juveniles for Phase I Intervention Run-Through; N=130 for Phase II RCT study) will be recruited from justice partners (probation, diversion programs) and school partners (high schools/middle schools). Participants will be randomized to either the VOICES (active) intervention (n=65) or a Girl Health (attention control) condition (n=65). In Phase I (first six months of Year 1), 6 juveniles will be recruited to complete the Intervention Run-Through and research assessment once to allow testing of RCT intervention and assessment procedures prior to the RCT phase. In Phase II (last half of Year 1 through Year 4), 130 girls will be recruited and randomized at baseline and then re-assessed at mid-treatment, end of treatment, 3 months and 6 months post-intervention. Biological specimens for juvenile drug use will also be collected at each 3-month assessment. Efficacy trial results can be used to make immediate changes to current widespread program delivery resulting in direct impact on the field of evidence-based gender-responsive substance use interventions for juvenile justice girls and young women.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
130 court-involved, non-incarcerated (CINI) female juvenile offenders or those at-risk for court-involvement, ages 12-24, who report any alcohol, marijuana or other drug use in the past 90 days will be eligible for enrollment with the following criteria:
Exclusion criteria
VOICES: A program of self-discovery and empowerment includes four modules: Self (A), Connecting with others (B), Healthy living (C), and the Journey Ahead (D). All sessions are 60 minutes long and include required and optional activities.
The Girl Health group comparison condition includes adolescent groups matched for time and attention to VOICES groups. Intervention take a psychoeducational/didactic approach and content focuses on a range of health behaviors, including substance use, exercise, nutrition and sleep.
Time frame: baseline, 1-month post-baseline (mid-treatment), 3 months post-baseline (end of treatment), and -3 and -6 month post-treatment completion to assess change over time
self-reported frequency (e.g., number of days used) as measured by the Adolescent Risk Behavior Assessment (ARBA)
Time frame: baseline, 1-month post-baseline (mid-treatment), 3 months post-baseline (end of treatment), and -3 and -6 month post-treatment completion to assess change over time
self-reported quantity and frequency (e.g., number of days used, number of drinks consumed each day) as measured by the Adolescent Risk Behavior Assessment (ARBA)
Time frame: baseline, 1-month post-baseline (mid-treatment), 3 months post-baseline (end of treatment), and -3 and -6 month post-treatment completion to assess change over time
self-reported quantity and frequency (e.g., number of days and types of other drugs used) as measured by the Adolescent Risk Behavior Assessment (ARBA)
Time frame: baseline, 3 months post-baseline (end of treatment), and -3 and -6 month post-treatment completion to assess change over time
Collateral measure of recent substance use (10-panel screen for Methadone, Amphetamine, Opiate, Oxycodone, Benzodiazepines, Barbiturates, Methamphetamine, Cocaine, Marijuana and Propoxyphene)
Time frame: baseline, 1-month post-baseline (mid-treatment), 3 months post-baseline (end of treatment), and -3 and -6 month post-treatment completion to assess change over time
self-reported frequency of sexual activity, condom use at last sex and substance use during sexual activity measured by the Adolescent Risk Behavior Assessment (ARBA)
Time frame: baseline, 1-month post-baseline (mid-treatment), 3 months post-baseline (end of treatment), and -3 and -6 month post-treatment completion to assess change over time
Brief Symptom Inventory (self-report psychiatric symptom questionnaire)
Time frame: baseline, 1-month post-baseline (mid-treatment), 3 months post-baseline (end of treatment), and -3 and -6 month post-treatment completion to assess change over time
National Stressful Events Survey PTSD Short Scale (NSESSS; self-report of posttraumatic stress symptoms and severity)
Time frame: baseline to 6-months post-treatment completion
Collateral/legal chart data to measure whether youth accrues any new/additional legal charges, is arrested and/or detained
University of California, San Francisco
Other
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