Experimental Mediation Research Aimed at Enhancing Adolescent Substance Abuse Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Changes From Baseline Scores Compared to Post-Treatment Scores, Any Positive Youth Urine Drug/Alcohol Screens (Measured at 0, 2, 4, 6, 9, & 12 Months).
研究概览
简要总结
The ultimate goal of this research is to facilitate rapid enhancement of youth substance abuse treatments by determining the key mechanisms of change (i.e., what to target more intensely to generate better outcomes). This work is critical because current outpatient adolescent substance abuse treatments yield only small to medium effects that diminish once treatment has ended. The proposed modern mediation study will address this serious public health problem by experimentally evaluating the most critical factors causing change in client outcomes during adolescent substance abuse treatment, directing the field to focus treatment efforts on those factors.
详细描述
Adolescents with substance use disorders (SUD) are at high risk for significant deleterious outcomes. Although several evidence-based practices for adolescent SUD exist, they yield only small to medium effects that rapidly diminish (30-70% 6-month relapse rates). A promising approach for determining how to enhance treatment is experimental mediation research. In contrast to traditional correlational mediation approaches, experimental mediation permits causal inference and is comprised of key steps: (A) Identify the putative mediating variable for a treatment. (B) Enhance the treatment to target that mediator more intensely. (C) Randomize youth to conditions, with the standard and enhanced versions of the treatment targeting different "levels" of the same mediator. (D) Measure the mediator and outcomes longitudinally. (E) Perform modern mediation analyses, coupled with analyses evaluating causal inference, to determine if changes in the mediator are responsible for changes in outcomes. This experimental test of mediation, focused on causality, facilitates rapid improvement of treatments by specifying change mechanisms to target in order to improve outcomes. These steps will be followed to elucidate the mediating processes in treatment for adolescent SUD, with the ultimate goal of enhancing the strength and durability of SUD treatments. The three most common putative mediating variables in adolescent SUD treatments are parent management, behavioral regulation, and peer relations. For this study, parent management was chosen as the target because it has evidenced the most potential for yielding generalizable change in youth outcomes and also has been shown to indirectly improve youths' behavioral regulation and peer relations. Of existing treatments for adolescent SUD, family-based Contingency Management (CM) was chosen as the treatment to enhance because it is highly amenable to an augmented focus on parenting, is less complex relative to other SUD treatments, and has amassed considerable support in terms of efficacy and dissemination potential. Thus, following experimental mediation steps, youth with SUD will be randomized to receive either standard CM or enhanced CM (i.e., CM+) that targets parenting more intensely. Repeated assessments for 12 months and longitudinal analyses will allow testing of mediating processes. The investigators will examine whether parent management skills mediate the effect of treatment on youth substance use and behavior problems (Aim 1). In addition, the investigators will determine whether parent management skills mediate the effect of treatment on youth behavioral regulation and deviant peer relations (Aim 2). Finally, the investigators will test whether behavioral regulation and deviant peer relations mediate the effect of parent management on youth substance use and behavior problems (Aim 3). Findings could have broad impact across multiple adolescent SUD treatments.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to 18 years
- •Presence of current substance use disorder
- •Availability of a parent/guardian willing to participate
排除标准
- •Actively psychotic, suicidal, or homicidal
- •Pervasive developmental disorder or metal retardation
结局指标
主要结局
Changes From Baseline Scores Compared to Post-Treatment Scores, Any Positive Youth Urine Drug/Alcohol Screens (Measured at 0, 2, 4, 6, 9, & 12 Months).
时间窗: Baseline to 12 months
Any positive urine screens for tetrahydrocannabinol (THC), synthetic THC, amphetamines, opiates, phencyclidine (PCP), cocaine, and/or alcohol metabolites (ethyl glucuronide, ethyl sulfate).
次要结局
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Problem Behaviors (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Youth Receipt of Required Contingency Management (CM) Treatment Components.(Course of treatment (length varied by participant))
- Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Inconsistent Discipline Subscale - Parent Report(Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Positive Parenting Subscale - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Poor Monitoring Subscale - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Inconsistent Discipline Subscale (Youth Report) (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Positive Parenting Subscale - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Parent Management - Poor Monitoring Subscale - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Substance Use Frequency (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Substance Problems (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Drive - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Fun Seeking - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Reward Responsiveness - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Drive - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Fun Seeking - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - Reward Responsiveness - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Risk Taking - BART (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Inhibitory Control - EATQ - Youth (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Inhibitory Control - EATQ - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Youth Behavioral Regulation - Inhibitory Control - Go No Go Performance (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Peer Relations - Peer Delinquency (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Peer Relations - Positive Peer Activity - Youth Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
- Changes From Baseline Scores Compared to Post-Treatment Scores for Peer Relations - Positive Peer Activity - Parent Report (Measured at 0, 2, 4, 6, 9, & 12 Months).(Baseline to 12 months)
研究者
Mike McCart
Senior Research Scientist
Oregon Social Learning Center