Gender-Responsive Drug Use Treatment for Juvenile Justice Girls

Drug Use Clinical Trial

Official title:

Gender-Responsive Drug Use Treatment for Juvenile Justice Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293057
• Other study ID #: R01DA035231-01A1
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2020

Study information

• Verified date: December 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 24 Years

Eligibility

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: 1) Determined to be in need of substance use treatment by the court intake worker, probation officer, presiding judge or magistrate, and/or school counselor; 2) Legal guardian available to consent for child's participation, if the child is under the age of 18, and 3) Child is English speaking.

Exclusion Criteria:

1. meet DSM-V criteria for substance use disorder with current severity rating of severe (6 or more symptoms) (as determined through referral partner);

2. already in substance use treatment (residential or outpatient) and wish to remain with outside provider (as determined through referral partner);

3. observable cognitive or developmental delays or active psychosis that would interfere with completing consent, assessment or intervention.

Related Conditions & MeSH terms

• Drug Use

Intervention

Behavioral:
• VOICES Group
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.
• Girl Health Group
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.

Locations

Country	Name	City	State
United States	UCSF Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marijuana Use	self-reported frequency (e.g., number of days used) as measured by the Adolescent Risk Behavior Assessment (ARBA)	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
Primary	Alcohol Use	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)	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
Primary	Other Drug Use	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)	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
Primary	Drug Urinalysis Screen	Collateral measure of recent substance use (10-panel screen for Methadone, Amphetamine, Opiate, Oxycodone, Benzodiazepines, Barbiturates, Methamphetamine, Cocaine, Marijuana and Propoxyphene)	baseline, 3 months post-baseline (end of treatment), and -3 and -6 month post-treatment completion to assess change over time
Primary	HIV/STI risk behavior	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)	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
Secondary	Psychiatric Symptoms	Brief Symptom Inventory (self-report psychiatric symptom questionnaire)	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
Secondary	Traumatic Stress	National Stressful Events Survey PTSD Short Scale (NSESSS; self-report of posttraumatic stress symptoms and severity)	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
Secondary	Recidivism	Collateral/legal chart data to measure whether youth accrues any new/additional legal charges, is arrested and/or detained	baseline to 6-months post-treatment completion