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临床试验/NCT02293057
NCT02293057已完成不适用

Gender-Responsive Drug Use Treatment for Juvenile Justice Girls

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
2
主要终点
Other Drug Use

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 24 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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:
  • 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.

排除标准

  • 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.

结局指标

主要结局

Other Drug Use

时间窗: 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)

Marijuana Use

时间窗: 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)

Alcohol Use

时间窗: 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)

Drug Urinalysis Screen

时间窗: 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)

HIV/STI risk behavior

时间窗: 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)

次要结局

  • 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)
  • Recidivism(baseline to 6-months post-treatment completion)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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