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Trial record 92 of 95 for:    Recruiting, Not yet recruiting, Active, not recruiting Studies | marijuana | United States

Gender-Responsive Drug Use Treatment for Juvenile Justice Girls

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ClinicalTrials.gov Identifier: NCT02293057
Recruitment Status : Recruiting
First Posted : November 18, 2014
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Marina Tolou-Shams, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Drug Use Behavioral: VOICES Group Behavioral: Girl Health Group Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gender-Responsive Drug Use Treatment for Juvenile Justice Girls
Study Start Date : September 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Active Comparator: 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.
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.

Placebo Comparator: Girl Health Group (Attention Control)
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
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.




Primary Outcome Measures :
  1. Marijuana Use [ 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)

  2. Alcohol Use [ 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)

  3. Other Drug Use [ 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)

  4. Drug Urinalysis Screen [ 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)

  5. HIV/STI risk behavior [ 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)


Secondary Outcome Measures :
  1. Psychiatric Symptoms [ 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)

  2. Traumatic Stress [ 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)

  3. Recidivism [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   To be eligible for the study, participants must be female-identified
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293057


Contacts
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Contact: Marina Tolou-Shams, Ph.D. 415-206-2212 marina.tolou-shams@ucsf.edu
Contact: Rahwa Abraham 415-206-6196 rahwa.abraham@ucsf.edu

Locations
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United States, California
UCSF Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94131
Contact: Rahwa Abraham    415-206-6196    rahwa.abraham@ucsf.edu   
Principal Investigator: Marina Tolou-Shams, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Marina Tolou-Shams, Ph.D. UC San Francisco

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Responsible Party: Marina Tolou-Shams, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02293057     History of Changes
Other Study ID Numbers: R01DA035231-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marina Tolou-Shams, University of California, San Francisco:
Adolescent
Juvenile Justice
Drug Use
Marijuana
Gender Responsive
Girls
HIV
Sexual Risk