Substance UseNCT06115746
A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
A study testing iDECIDE in people with Substance Use and Harm Reduction, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 9 to 22 years
- Conditions the study is for
- Substance Use, Harm Reduction, Adolescent Behavior
- What is being tested?
- iDECIDE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2023to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Randi M Schuster, PhD, 617-643-6673, Rschuster@mgh.harvard.edu
Randi M Schuster, PhD
About this study
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.
Read the detailed description
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.
- Conditions
- Substance Use, Harm Reduction, Adolescent Behavior
- Being tested
- iDECIDE
- Keywords
- Adolescent, Diversion program, iDECIDE, Tier 2, School, Substance use prevention, Addiction, Early intervention, Targeted prevention
- Medical subject headings
- Substance-Related Disorders, Harm Reduction, Adolescent Behavior, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDECIDEBehavioural
Also called Drug Education Curriculum: Intervention, Diversion, and Empowerment
iDECIDE is a 4-session drug education and diversion program that addresses topics such as the neurobiology and addiction, adolescent brain development, industry tactics, motives for using substances, risk and protective factors, identifying triggers, healthy alternatives, core values, and long-term goal setting. These topics are taught via facilitated discussions, videos, worksheets, and handouts. The iDECIDE drug curriculum will be delivered weekly for 4 weeks via videoconference or in-person visits. Each session typically takes 60-75 minutes. For this study, facilitators are members of study staff.
| Study group | Role | What they receive |
|---|---|---|
| iDECIDE | Experimental | 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. Receives: Behavioral: iDECIDE |
| Waitlist Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Drug Effects and Brain Development
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.
Measured: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Frequency of Substance Use
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.
Measured: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Readiness to Quit or Reduce Substance Use
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).
Measured: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Perceived Harm of Substance Use
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.
Measured: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start17 Nov 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Approximately 300 participants will be enrolled into a two-arm, assessor-blind, randomized controlled trial to compare substance use outcomes (i.e., knowledge, behavior, and attitudes) across a one-year follow-up period in adolescents randomly assigned to the iDECIDE drug curriculum or the waitlist control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Department of Health
- Responsible party
- Principal investigator, Randi Melissa Schuster, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115746
- Sponsor's protocol ID
- 2023P000808
- Other IDs
- INTF2400H78500224455
- Status last verified
- Oct 2025
- First submitted
- 30 Oct 2023
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie reported results (after de-identification \[text, tables, figures, and appendices\]), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@harvard.mgh.edu. To gain access, data requestors will need to sign a data access agreement.
Publications
Liu J, Butler R, Turncliff A, Gray C, Lynch S, Whittaker J, Iroegbulem V, Howell D, Schuster RM. An Urgent Need for School-Based Diversion Programs for Adolescent Substance Use: A Statewide Survey of School Personnel. J Adolesc Health. 2023 Sep;73(3):428-436. doi: 10.1016/j.jadohealth.2023.04.006. Epub 2023 Jun 15.
PubMed 37318411Schuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023.
PubMed 37009114
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
- ClinicalTrials.gov ID
- NCT06115746
- Acronym / sponsor ID
- 2023P000808
- Conditions
- Substance Use, Harm Reduction, Adolescent Behavior
- Keywords
- Adolescent, Diversion program, iDECIDE, Tier 2, School, Substance use prevention, Addiction, Early intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Department of Health
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Approximately 300 participants will be enrolled into a two-arm, assessor-blind, randomized controlled trial to compare substance use outcomes (i.e., knowledge, behavior, and attitudes) across a one-year follow-up period in adolescents randomly assigned to the iDECIDE drug curriculum or the waitlist control group.
| Arm | Type | Receives |
|---|---|---|
| iDECIDE | Experimental | Behavioral: iDECIDEParticipants 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. |
| Waitlist Control Group | No 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. |
Who may qualify
- Ages
- 9 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iDECIDEAlso: Drug Education Curriculum: Intervention, Diversion, and EmpowermentiDECIDE is a 4-session drug education and diversion program that addresses topics such as the neurobiology and addiction, adolescent brain development, industry tactics, motives for using substances, risk and protective factors, identifying triggers, healthy alternatives, core values, and long-term goal setting. These topics are taught via facilitated discussions, videos, worksheets, and handouts. The iDECIDE drug curriculum will be delivered weekly for 4 weeks via videoconference or in-person visits. Each session typically takes 60-75 minutes. For this study, facilitators are members of study staff. | Behavioural | iDECIDE |
Primary outcome
Knowledge of Drug Effects and Brain Development
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Background: PubMed 37318411Liu J, Butler R, Turncliff A, Gray C, Lynch S, Whittaker J, Iroegbulem V, Howell D, Schuster RM. An Urgent Need for School-Based Diversion Programs for Adolescent Substance Use: A Statewide Survey of School Personnel. J Adolesc Health. 2023 Sep;73(3):428-436. doi: 10.1016/j.jadohealth.2023.04.006. Epub 2023 Jun 15.
- Background: PubMed 37009114Schuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie reported results (after de-identification [text, tables, figures, and appendices]), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@harvard.mgh.edu. To gain access, data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iDECIDE in people with Substance Use and Harm Reduction, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randi M Schuster, PhD (6176436673, rschuster@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of Drug Effects and Brain Development (time frame: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06115746, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.