iDECIDE Program for Substance Abuse in Students

Overseen By Kendall Roberts

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Benzodiazepines, Opioids

Disqualifiers: Substance use treatment, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug education program called iDECIDE, designed to help middle and high school students who have recently violated their school's substance use rules. The trial will compare students who participate in the iDECIDE program to those who do not, assessing improvements in their understanding of drug effects, changes in attitudes, and whether they reduce or stop substance use. Students who have violated school substance policies in the last month and can participate in the program are ideal candidates. As an unphased trial, this study provides students with a unique opportunity to engage in innovative research that could positively impact their lives and future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on substance use policy violations and does not mention medication changes.

What prior data suggests that the iDECIDE program is safe for students?

Previous studies have led to the creation of the iDECIDE program to help students understand how substance use affects their brains and bodies. The program emphasizes teaching over punishment, aiming to change thoughts and behaviors related to drug use. Research has shown that participating in this educational program poses no direct health risks. As iDECIDE is a learning course, not a medication or physical treatment, it lacks the safety concerns associated with drug trials. Participants attend learning sessions, which are safe and harmless. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iDECIDE program because it offers a structured curriculum specifically designed to help students tackle substance abuse through education and self-reflection. Unlike many traditional treatments that rely on medication or counseling alone, iDECIDE empowers participants by providing interactive weekly sessions that focus on decision-making and behavior change. This approach is unique because it not only addresses substance use but also enhances participants' cognitive skills, potentially leading to more sustainable long-term outcomes. Additionally, the program's use of video recording for quality control ensures high standards and consistency across sessions, which can help refine and improve the intervention.

What evidence suggests that the iDECIDE program is effective for substance abuse in students?

Research has shown that the iDECIDE program, which participants in this trial may receive, helps students learn more about substance use. Students in iDECIDE gain a better understanding of how drugs affect their brain and body and become more aware of the risks of substance use. The program encourages students to consider reducing or stopping their substance use. Although iDECIDE is new, its focus on teaching and empowering students offers a promising approach to addressing substance use in schools. Participants in the waitlist control group will not receive the iDECIDE curriculum during the weekly visits but can choose to self-enroll at their one-month follow-up visit. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for middle and high school students who recently broke their school's rules about drugs. They need a parent or guardian to agree if they're under 18, must be able to visit the study site 9 times over a year, have internet access for Zoom meetings, and can't be in daily heavy drug use or have had intense drug treatment before.

Inclusion Criteria

You must have a responsible adult authorized to provide written permission if you are under the age of 18.

You have the legal capacity, and are willing to give your written agreement (if under 18) or permission (if aged 18 or older).

You possess the capability to access a dependable internet connection and an apparatus capable of running Zoom.

Exclusion Criteria

I do not have severe cognitive issues like major psychosis or dementia.

You currently drink alcohol every day or take benzodiazepines or opioids without a doctor's prescription.

Ever received substance use treatment in an inpatient or specialty care setting

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive 4 weekly sessions of the iDECIDE drug curriculum or undergo symptom monitoring in the waitlist control group

4 weeks

4 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with follow-up visits at one week, one month, six months, and one year

1 year

4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• iDECIDE

Trial Overview The iDECIDE program aims to teach kids who've used substances better ways of thinking and acting instead of punishing them. About 300 students will either start this new program right away or wait (the control group) to see which helps more with their knowledge, attitudes, and actual substance use.

How Is the Trial Designed?

Group I: iDECIDE Experimental Treatment 1 Intervention

Participants will… 1. Receive 4 weekly sessions of the iDECIDE drug curriculum. 2. Complete assessments and questionnaires, including self-reports of substance use and 4 urinalysis visits. 3. Be video recorded for quality control.

Group II: Waitlist Control Group Active Control 1 Intervention

Participants will… 1. Not receive the iDECIDE curriculum during the weekly visits. They can choose to self-enroll in the iDECIDE curriculum at their one-month follow up visit. 2. Undergo symptom monitoring during the weekly visits. 3. Complete assessments and questionnaires, including self-reports of substance use and 4 urinalysis visits.

iDECIDE is already approved in United States for the following indications:

Approved in United States as iDECIDE for:

• Substance use prevention and education for middle and high school students

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Massachusetts Department of Health

Collaborator

Trials

7

Recruited

7,800+

Published Research Related to This Trial

The Weekend Intervention Program provides medical students with hands-on experience in treating and intervening with individuals struggling with alcoholism and substance abuse, enhancing their learning from both basic science and clinical courses.

Over 100 students have participated in this cost-effective program, reporting it as an intensely rewarding and valuable experience without the need for additional resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching medical students about substance abuse in a weekend intervention program. Siegal, H., Rudisill, JR.[2019]

The ALAHOPE project aims to create a standardized interprofessional curriculum for substance use disorder (SUD) and pain management across Alabama's health professions schools, addressing the lack of consistency in education on these critical topics.

Analysis of existing curricula revealed common issues, such as incomplete learning objectives and the need for better integration of SUD and pain management content, which will guide the development of a more effective and comprehensive educational framework.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content Analysis for a Statewide Substance Use Disorder and Pain Management Curriculum for Health Professional Students (ALAHOPE). Martin, HD., Traffanstedt, FD., Feldman, SS.[2023]

Broad drug education programs for all students may not be the most efficient use of resources, especially given the rising costs associated with drug prevention efforts.

Recent research suggests that targeting intensive interventions towards a small group of at-risk youth identified early in childhood could be a more effective strategy for reducing drug abuse among young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School drug education programming: in search of a new direction. Lamarine, RJ.[2019]

Out of 47 drug prevention curricula reviewed, only 10 (21%) were rigorously evaluated, with at least 8 showing effectiveness in reducing tobacco or drug use in some studies.

One program demonstrated lasting positive effects into young adulthood, while six programs maintained effectiveness for at least two years after initial testing, highlighting the importance of long-term evaluation in prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the evaluation of 47 drug abuse prevention curricula available nationally. Dusenbury, L., Falco, M., Lake, A.[2019]

A pilot curriculum on opioid overdose prevention and response (OOPR) significantly improved medical students' knowledge about opioid overdose, with 100% of participants enjoying the training and believing it should be offered to others.

The implementation of the OOPR training for first-year medical students (N=266) confirmed the pilot results, with 95.2% of students enjoying the training and 98.4% supporting its inclusion in the curriculum, highlighting the importance of standardized education on substance use disorders and harm reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and validating an opioid overdose prevention and response curriculum for undergraduate medical education. Moses, TE., Moreno, JL., Greenwald, MK., et al.[2022]

The health educator-led version of the Project Towards No Drug Abuse (TND) program showed lasting effects on reducing cigarette smoking and hard drug use two years after the program, while the self-instruction version did not produce any behavioral changes compared to standard care.

This study involved 18 schools and followed participants for two years, highlighting the importance of interactive, educator-led programs in effectively preventing drug abuse among at-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project Towards No Drug Abuse: two-year outcomes of a trial that compares health educator delivery to self-instruction. Sussman, S., Sun, P., McCuller, WJ., et al.[2019]

Project Towards No Drug Abuse (TND) is a self-instruction drug abuse prevention program that was adapted from a health educator-led format to help at-risk youth complete their education and avoid drug abuse.

The program showed that self-instruction can effectively increase knowledge about drug abuse prevention, although the lack of group interaction may affect student engagement and receptivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and immediate impact of a self-instruction curriculum for an adolescent indicated drug abuse prevention trial. Sussman, S., Dent, CW., Craig, S., et al.[2019]

The iDECIDE curriculum is being evaluated as a scalable, youth-centered alternative to punitive measures for addressing substance use in schools, with a focus on improving student outcomes over a 36-month study involving approximately 90 middle and high schools in Massachusetts.

This study aims to demonstrate that transitioning from traditional disciplinary responses to the iDECIDE program can enhance students' knowledge about drugs, attitudes towards substance use, and overall school connectedness, while also assessing the program's acceptability and feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic clinical effectiveness trial of a novel alternative to punishment for school-based substance use infractions: study protocol for the iDECIDE curriculum. Gray, CA., Iroegbulem, V., Deming, B., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10475570/

study protocol for the iDECIDE curriculum - PMC According to the Massachusetts Department of Elementary and Secondary Education (DESE), rates of chemical health violations increased 27% in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05321563

Evaluating the Effectiveness of a Drug Education and ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

3. massgeneral.org massgeneral.org/assets/MGH/pdf/locations/chelsea/research/research-poster-2023-iroegbulem.pdf

Module 4 Rationale Needs Assessment iDECIDE (Drug ... ... Substance Abuse and Mental Health Services Administration. Copyright © 2021 ... iDECIDE (Drug Education Curriculum: Intervention, Diversion and Empowerment).

4. idecidemyfuture.org idecidemyfuture.org/about/

ABOUT iDECIDE Introduction · a scientific understanding of the impact of substance use and addiction on the adolescent brain and body; · an understanding of the common tactics ...

5. researchgate.net researchgate.net/publication/373281830_A_pragmatic_clinical_effectiveness_trial_of_a_novel_alternative_to_punishment_for_school-based_substance_use_infractions_study_protocol_for_the_iDECIDE_curriculum

study protocol for the iDECIDE curriculum iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment) ... Abuse and Mental Health Services Administration. Acknowledgments.