Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School Students
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Knowledge of drug effects from baseline to 90 day follow-up
研究概览
简要总结
The primary goal of this study is to evaluate the effectiveness of the iDECIDE curriculum as an alternative to punitive responses for school-based substance use infractions.
详细描述
The primary goal of this study is to evaluate the effectiveness of the iDECIDE curriculum as an alternative to punitive responses for school-based substance use infractions. To accomplish this aim, investigators will conduct a Type 1, hybrid effectiveness-implementation trial. Using a stepped wedge design, investigators will randomly allocate the timing of implementation of the iDECIDE curriculum compared to standard disciplinary response, over approximately 24 months. Investigators are testing the overarching hypothesis that student-level outcomes improve when schools transition from a standard disciplinary response to having access to a more educational and therapeutic alternative. Participants for this aim will include students referred by schools with substance use infractions who are assessed by the study team at baseline (proximal to the time of infraction), 45, and 90 days later.
Exploratory aims of this study include:
- Change in school environment -- Evaluating the impact of transition from punitive responses for substance use to iDECIDE on overall prevalence of substance use and perceptions of school culture. Participants for this exploratory aim include all students within participating schools (not just those with substance use infractions), assessed annually beginning Fall 2022.
- Single arm pre/post change -- Evaluating change from session 1 to session 4 of iDECIDE in perceptions of harm from substance use, knowledge of drug effects, perceptions of a supportive school culture, plans to change substance use, and frequency of past 7-day substance use in all students who complete the iDECIDE curriculum. Investigators will also explore whether any change in these outcomes differ among historically underserved populations, including racial and gender minority students. Participants for this exploratory aim incIude all students who participate in the iDECIDE curriculum, regardless of the reason for referral into the program and the provision of parental consent for collection of data for primary aims.
- Identification of implementation barriers -- Evaluating the feasibility and acceptability of the iDECIDE curriculum by identifying multi-level barriers and facilitators to implementation using mixed methods. Participants for this exploratory aim include school stakeholders, interviewed right before and 6 months following iDECIDE implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Individuals collecting longitudinal student-level data for the primary aims will be blind to group assignment. Initial implementation of analyses for primary aims will also be 'analyst-blind.' Analyses for primary aims will first be implemented on data where the key factor of interest (whether the 45-day and 90-day follow-ups occurred post-intervention) has been randomly shuffled. Only once data exclusion criteria have been finalized, models have been properly specified, and any other unforeseen circumstances addressed, will the un-shuffled data be provided to the analyst for the final analysis implementation.
入排标准
- 年龄范围
- 10 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in a participating middle or high school;
- •Received a substance use-related infraction at school or school-sanctioned event;
- •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 consent (if age 18+) or assent (if under 18);
- •Able to read and write comfortably in English;
- •In the opinion of the investigator, able to safely participate in the protocol.
排除标准
- •Passive consent for referral to MGH evaluation team declined by parent or legal guardian;
- •Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease;
- •Ward of the state.
- •Eligibility criteria for participants for exploratory aims:
- •In addition to the students with school-based substance use infractions enrolled for the primary aims, three additional cohorts of participants will be recruited for exploratory aims. The eligibility criteria for these cohorts are listed below.
- •Exploratory Aim 1: evaluating the impact of transition from punitive responses for substance use to iDECIDE on overall prevalence of substance use and perceptions of school culture (Annual School-Wide Assessment)
- •Inclusion Criteria:
- •Currently enrolled in a participating middle or high school;
- •Provide informed assent/consent for participation in this research by voluntarily completing the survey.
- •Exclusion Criteria:
- •Passive consent for school-wide assessment declined by parent or legal guardian;
- •Not able to adequately read and respond to survey items in one of the languages available.
- •Exploratory Aim 2: Evaluating change from session 1 to session 4 of iDECIDE in perceptions of harm from substance use, knowledge of drug effects, perceptions of a supportive school culture, plans to change substance use, and frequency of past 7-day substance use in all students who complete the iDECIDE curriculum.
- •Inclusion Criteria:
- •Enrolled in the iDECIDE curriculum by a trained iDECIDE facilitator.
- •Exclusion Criteria:
- •Unable to adequately read and respond to survey items in one of the languages available.
结局指标
主要结局
Knowledge of drug effects from baseline to 90 day follow-up
时间窗: Baseline - 90 days
Knowledge of drug effects will be measured by number of items correct on a survey examining a student's understanding of adolescent brain development, neurobiology of addiction, and the impact of alcohol, cannabis, nicotine and other substance use on the brain and body.
Frequency of substance use from baseline to 90 day follow-up
时间窗: Baseline - 90 days
Frequency of substance use will be operationalized as the number of days spent using student's preferred substance assessed via 14-day timeline followback.
次要结局
- Emotional support from baseline to 90 day follow-up(Baseline - 90 days)
研究者
Randi Melissa Schuster
Assistant Professor
Massachusetts General Hospital