Gender-Responsive Drug Use Treatment for Juvenile Justice Girls

NCT02293057 | Completed DMC

• 1 other identifier: R01DA035231-01A1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Use

Keywords

Adolescent; Juvenile Justice; Drug Use; Marijuana; Gender Responsive; Girls; HIV; Sexual Risk

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Psychiatric Symptoms

  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

• Traumatic Stress

  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

• Recidivism

  baseline to 6-months post-treatment completion

Study Arms (2)

VOICES Group

ACTIVE COMPARATOR

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.

Behavioral: VOICES Group

Girl Health Group (Attention Control)

PLACEBO COMPARATOR

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.

Behavioral: Girl Health Group

Interventions

VOICES Group BEHAVIORAL

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.

VOICES Group

Girl Health Group BEHAVIORAL

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.

Girl Health Group (Attention Control)

Eligibility Criteria

• Age: 12 Years - 24 Years
• Gender Eligibility Details: To be eligible for the study, participants must be female-identified
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• \) 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.

You may not qualify if:

• meet DSM-V criteria for substance use disorder with current severity rating of severe (6 or more symptoms) (as determined through referral partner);
• already in substance use treatment (residential or outpatient) and wish to remain with outside provider (as determined through referral partner);
• observable cognitive or developmental delays or active psychosis that would interfere with completing consent, assessment or intervention.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, 94131, United States

Location

Related Publications (1)

• Ramos LMC, Delgadillo J, Velez S, Dauria E, Salas J, Tolou-Shams M. Collecting Social Media Information in a Substance Use Intervention Trial With Adolescent Girls With Lifetime Substance Use History: Observational Study. JMIR Form Res. 2021 Sep 10;5(9):e25405. doi: 10.2196/25405.

  PMID: 34505833 DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Marina Tolou-Shams, Ph.D.

  UC San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 18, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 23, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)