Substance Use (Drugs, Alcohol)iDECIDENCT07918963
Pilot of a Drug Education Curriculum for Middle and High School Students
A study testing iDECIDE in people with Substance Use (Drugs, Alcohol) and Health Risk Behaviors, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this pilot study is to measure the feasibility, sustainability, and acceptability of a drug education curriculum (IDECIDE) in middle and high students who have endorsed past-month substance use.The main question it aims to answer is: 1) What is the impact of iDECIDE on the the knowledge of drug effects and… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Substance Use (Drugs, Alcohol), Health Risk Behaviors, Youth
- 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
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2021to 11 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children and adolescents who are currently enrolled in middle or high school;
- Have currently used (i.e., at least once in the past 30 days) any substance without a prescription;
- Have a parent or legal guardian who is able and willing to provide written informed consent for the active study phase (if under the age of 18);
- Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
- Competent and able to provide written informed consent (if age 18 or older);
- Able to communicate in English language;
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- Able to commit to 7 study visits in approximately 2 months;
- 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.
Who cannot join
- Ever been in substance use treatment;
- Ever engaged in IV drug use;
- Current daily alcohol, or daily non-medical benzodiazepine and/or opioid use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Development of a Drug Education Curriculum for Middle and High School Students
The goal of this pilot study is to measure the feasibility, sustainability, and acceptability of a drug education curriculum (IDECIDE) in middle and high students who have endorsed past-month substance use.The main question it aims to answer is:
- What is the impact of iDECIDE on the the knowledge of drug effects and teen brain development, attitudes and perceptions of drug-related harms, and willingness to quit or reduce substance use?
Participants will be asked to participate in 4 sessions of the iDECIDE curriculum and complete surveys and interview questionnaires over the course of approximately 3 months.
Read the detailed description
This study will be a one-arm pilot study enrolling approximately 100 middle and high school students who have endorsed substance use in the past month. Participants will be followed over 3 months. All participants will receive iDECIDE 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. Data collection will occur during seven visits over the span of approximately three months, including one baseline visit, four weekly visits during the intervention phase of the study, and then two follow-up visits. The follow-up visits will occur at approximately one week and one month following the end-of-intervention. Participants will complete questionnaires and assessments throughout the study. Primary outcomes (Knowledge of Drug Effects and Brain Development readiness to quit, readiness to reduce, perceptions of harm) will be assessed at visit 1 (baseline), visit 6 (one week follow-up), and visit 7 (one month follow-up). Participants will be compensated for session attendance.
- Being tested
- iDECIDE
- Keywords
- iDECIDE, Diversion Program, Adolescent Substance Use, Tier 2 Services, School-Based Intervention
- Medical subject headings
- Substance-Related Disorders, Health Risk Behaviors, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDECIDEBehavioural
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. Receives: Behavioral: iDECIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Drug Effects & Brain Development
Knowledge of Drug Effects and Brain Development will be measured by number of items correct on a 25-item 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, one-week follow-up, one-month follow-up
Readiness to Quit or Reduce Substance Use
Participants will complete a Readiness Ruler to determine how ready they are to quit and reduce their primary substance on a scale from 1 (not at all ready) to 10 (very ready).
Measured: Baseline, one-week follow-up, one-month follow-up
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, one-week follow-up, one-month follow-up
Secondary outcomes (1)
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. Participants will be prompted to share their substance use since their baseline and follow-up visits during the one-week and one-month follow-up visits, respectively.
Measured: Baseline, one-week follow-up, one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start4 Mar 2021
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use (Drugs, Alcohol)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive the iDECIDE intervention.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
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
- NCT07918963
- Sponsor's protocol ID
- 2020P000727
- Other IDs
- INTF2400H78500224455, INTF2300H78500224179
- Acronym
- iDECIDE
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Drug Education Curriculum for Middle and High School Students
- ClinicalTrials.gov ID
- NCT07918963
- Acronym / sponsor ID
- iDECIDE / 2020P000727
- Keywords
- iDECIDE, Diversion Program, Adolescent Substance Use, Tier 2 Services, School-Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Department of Health
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 5 Nov 2026 (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 goal of this pilot study is to measure the feasibility, sustainability, and acceptability of a drug education curriculum (IDECIDE) in middle and high students who have endorsed past-month substance use.The main question it aims to answer is:
- What is the impact of iDECIDE on the the knowledge of drug effects and teen brain development, attitudes and perceptions of drug-related harms, and willingness to quit or reduce substance use?
Participants will be asked to participate in 4 sessions of the iDECIDE curriculum and complete surveys and interview questionnaires over the course of approximately 3 months.
Detailed description
This study will be a one-arm pilot study enrolling approximately 100 middle and high school students who have endorsed substance use in the past month. Participants will be followed over 3 months. All participants will receive iDECIDE 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. Data collection will occur during seven visits over the span of approximately three months, including one baseline visit, four weekly visits during the intervention phase of the study, and then two follow-up visits. The follow-up visits will occur at approximately one week and one month following the end-of-intervention. Participants will complete questionnaires and assessments throughout the study. Primary outcomes (Knowledge of Drug Effects and Brain Development readiness to quit, readiness to reduce, perceptions of harm) will be assessed at visit 1 (baseline), visit 6 (one week follow-up), and visit 7 (one month follow-up). Participants will be compensated for session attendance.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive the iDECIDE intervention.
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Children and adolescents who are currently enrolled in middle or high school;
- Have currently used (i.e., at least once in the past 30 days) any substance without a prescription;
- Have a parent or legal guardian who is able and willing to provide written informed consent for the active study phase (if under the age of 18);
- Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
- Competent and able to provide written informed consent (if age 18 or older);
Key exclusion criteria (3 listed)
- Ever been in substance use treatment;
- Ever engaged in IV drug use;
- Current daily alcohol, or daily non-medical benzodiazepine 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 |
|---|---|---|
| iDECIDEiDECIDE 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 & Brain Development
Time frame: Baseline, one-week follow-up, one-month follow-up
Knowledge of Drug Effects and Brain Development will be measured by number of items correct on a 25-item 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.
Readiness to Quit or Reduce Substance Use
Time frame: Baseline, one-week follow-up, one-month follow-up
Participants will complete a Readiness Ruler to determine how ready they are to quit and reduce their primary substance on a scale from 1 (not at all ready) to 10 (very ready).
Perceived Harm of Substance Use
Time frame: Baseline, one-week follow-up, one-month follow-up
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.
1 secondary outcome
Frequency of Substance Use
Time frame: Baseline, one-week follow-up, one-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Curriculum WebsiteLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (Drugs, Alcohol) and Health Risk Behaviors, 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 9 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: finished, as of the sponsor's last update on 5 Nov 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge of Drug Effects & Brain Development (time frame: Baseline, one-week follow-up, one-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.