A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Knowledge of Drug Effects and Brain Development
研究概览
简要总结
The primary goal of this study is to test the effectiveness of the iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment) curriculum, a novel drug education and diversion program, in approximately 300 middle and high school students, who have violated their school substance use policies in the past month, as an alternative to punitive school responses for school-based substance use infractions. This randomized controlled trial will test the hypothesis that adolescents randomized to the iDECIDE curriculum will have improved substance use outcomes (i.e., knowledge, attitudes, and behavior) compared to adolescents in a waitlist control group. The outcomes of this study will measure knowledge of drug effects and brain development, perceptions of harm from substance use, willingness to quit or reduce use, and substance use behavior.
详细描述
This study will be a two-arm, assessor-blind, randomized controlled trial enrolling approximately 300 middle and high school students who have recently violated a school substance use policy. Participants will be followed over a one-year period. Participants will be randomly assigned to either four-weeks of iDECIDE or a waitlist control group. Participants assigned to receive iDECIDE will receive a drug education curriculum developed to provide behavioral support and psychoeducation via videoconference or in-person visits. The purpose of iDECIDE is to provide students with the knowledge and skills they need to make healthy decisions regarding substance use. Participants in the waitlist control group will undergo symptom and substance use monitoring only, until completion of the one-month follow-up visit at which point they will be offered the opportunity to enroll in the iDECIDE curriculum, if desired. Data collection will occur during nine visits over the span of approximately one year, including one randomization baseline visit, four weekly visits during the intervention phase of the study during which time participants will participate in either iDECIDE or monitoring, and then four follow-up visits. The follow-up visits will occur at approximately one week, one month, six months, and one year following the end-of-intervention. Participants in both arms will complete questionnaires and assessments conducted by raters blinded to study arm assignment. Primary outcomes (knowledge of drug effects, knowledge of brain development and neurobiology of addiction, readiness to quit, perceptions of harm, and frequency of substance use) will be assessed at visit 1 (baseline), visit 5 (end-of-intervention), visit 6 (one week follow-up), and visit 7 (one month follow-up). Participants will be compensated for session attendance and provision of urine samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Eligible participants will be randomly assigned at the end of the baseline visit in a 1:1 ratio, in blocks of 6, to either a waitlist control group or the iDECIDE curriculum group. Randomization will be stratified by substance use frequency. Treatment will be assigned according to study number, assigned sequentially to eligible participants who enroll in the trial and attend the baseline visit. Investigators and outcome assessors will be fully blinded to allocation across the two arms. Facilitators of the iDECIDE curriculum will not be involved with the data outcome assessments.
入排标准
- 年龄范围
- 9 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently enrolled in middle or high school;
- •Violated school substance use policy within approximately the past month at the time of screening;
- •Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
- •Competent and willing to provide written informed assent (if under the age of 18) or written informed consent (if age 18 or older);
- •Able to commit to 9 study visits over approximately one year;
- •Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator;
- •Has access to a reliable internet connection and a device that can run Zoom;
- •Able to read and write comfortably in one of the languages spoken by study staff.
排除标准
- •Ever received substance use treatment in an inpatient or specialty care setting;
- •Ever engaged in intravenous (IV) drug use;
- •Current daily use of alcohol, non-medical benzodiazepines, and/or opioid use.
结局指标
主要结局
Knowledge of Drug Effects and Brain Development
时间窗: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Knowledge of drug effects and brain development will be measured with a multiple choice questionnaire that assesses knowledge taught in the iDECIDE curriculum, including neurobiology of addiction, side effects of substance, and industry tactics to market substances to young audiences.
Frequency of Substance Use
时间窗: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
The Timeline Follow-Back (TLFB) will be used to measure number of days the participant used a substance, which substances were used, and the frequency of which substances were used. The initial TLFB at the baseline visit will measure substances used in the past 90 days, while the interim TLFB will measure substances used since each subsequent visit. Participants will also provide a urine sample at study visits 1, 5, 6, 7 to qualitatively screen for substances including amphetamines, cocaine, barbiturates, methamphetamines, benzodiazepines, opiates, marijuana, phencyclidine, propoxyphene, and methaqualone using a urine 10-panel. There will also be an assay to quantitate levels of cotinine and creatinine-adjusted carboxy THC at baseline, end-of-intervention, one-week follow-up, and one-month follow-up. The primary outcome will be change in frequency of past week use (number of days) for the substance used most frequently at baseline.
Readiness to Quit or Reduce Substance Use
时间窗: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Participants will complete a Readiness Ruler to determine how ready they are to reduce their substance use on a scale from 1 (not at all ready) to 10 (very ready).
Perceived Harm of Substance Use
时间窗: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
The Perceived Harm of Substance Use measure was modified from the 2010 National Survey on Drug Use and Health. Participants will assess their perceived harm of various forms of substance use using four response categories that range from no risk to great risk.
次要结局
未报告次要终点
研究者
Randi Melissa Schuster
Associate Professor
Massachusetts General Hospital