Adolescent BehavioriDECIDENCT05321563

Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School Students

A study testing iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment) in people with Adolescent Behavior and Substance Use, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 10 to 22 years
Conditions the study is for: Adolescent Behavior, Substance Use, Youth
What is being tested?: iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2022to 14 Sep 2023
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 10 to 22 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

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Currently enrolled in a participating middle or high school;
Provide informed assent/consent for participation in this research by voluntarily completing the survey.
Enrolled in the iDECIDE curriculum by a trained iDECIDE facilitator.

Who cannot join

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)

Show all 10Show fewer

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.
Unable to adequately read and respond to survey items in one of the languages available.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions: Adolescent Behavior, Substance Use, Youth, Health Risk Behaviors
Being tested: iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)
Keywords: Diversion Program, Adolescent Substance Use, Middle and High School Students, Indicated Early Intervention, Tier 2 Services, School-Based Intervention
Medical subject headings: Adolescent Behavior, Substance-Related Disorders, Health Risk Behaviors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)Behavioural
iDECIDE is a 4 session curriculum that addresses topics such as the neurobiology of substance use, adolescent brain development, industry tactics, motivations for using substances, risk and protective factors, triggers, healthy alternatives, core values, and long-term goal setting. These topics are taught via facilitated discussions, videos, worksheets, and handouts. Facilitators are selected by schools and community agencies to receive free trainings conducted by the iDECIDE team, which includes personnel from the Massachusetts Department of Public Health, Massachusetts General Hospital (MGH) Center for Addiction Medicine, and the Institute for Health and Recovery.

Study groups in NCT05321563
Study group	Role	What they receive
Observation Phase	No intervention	Schools will continue to apply their standard disciplinary response to school-based substance use infractions during the 'unexposed' study period.
Intervention Phase	Experimental	Schools will have the opportunity to deliver the iDECIDE curriculum in lieu of or as part of the standard disciplinary response to school-based substance use infractions during the 'exposed' study period. Receives: Behavioral: iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)

What is being measured

The primary outcome is the main question the study is designed to answer.

Knowledge of drug effects from baseline to 90 day follow-up
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.
Measured: Baseline - 90 days
Frequency of substance use from baseline to 90 day follow-up
Frequency of substance use will be operationalized as the number of days spent using student's preferred substance assessed via 14-day timeline followback.
Measured: Baseline - 90 days

Secondary outcomes (1)

Emotional support from baseline to 90 day follow-up
Quality of relationships with teachers/administrators, school connectedness, and social and emotional satisfaction at school will be measured using summed scores from the NIH Toolbox Emotional Support Fixed Form Ages 8-17 v2.0, modified to specifically query about emotional support from adults in school. Raw scores range from 7 to 33 (age- and gender- corrected T-scores also available), with higher scores indicative of more social support.
Measured: Baseline - 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 202214 Sep 2023

First posted11 Apr 2022
Study start4 Feb 2022
Primary completion14 Sep 2023
Study completion14 Sep 2023

Why it stopped: Due to changes in state policy, the need for a comprehensive Tier 2 diversion program became apparent. The PI and Project Officer at MA DPH opened up programming statewide and updated the evaluation plan (NCT06115746).

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Adolescent BehaviorStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a type 1, hybrid effectiveness-implementation trial using a stepped wedge design with stratified, clustered randomization. Investigators will randomly allocate the timing of implementation of the iDECIDE curriculum compared to standard disciplinary response, over approximately 24 months. Schools will cross over from control (i.e., standard disciplinary response) to intervention (i.e., iDECIDE curriculum) with all schools exposed to iDECIDE by the end of the trial.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05321563
Sponsor's protocol ID: 2021P002611
Other IDs: INTF2300H78500224179, INTF2400H78500224455
Acronym: iDECIDE
Status last verified: Dec 2024
First submitted: 18 Mar 2022
Last updated: 5 Dec 2024
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 deidentification \[text, tables, figures, and appendices\]), 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

Gray CA, Iroegbulem V, Deming B, Butler R, Howell D, Pascale MP, Bodolay A, Potter K, Turncliff A, Lynch S, Whittaker J, Ward J, Maximus D, Pachas GN, Schuster RM. A pragmatic clinical effectiveness trial of a novel alternative to punishment for school-based substance use infractions: study protocol for the iDECIDE curriculum. Front Public Health. 2023 Aug 21;11:1203558. doi: 10.3389/fpubh.2023.1203558. eCollection 2023.
PubMed 37670822

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School Students
ClinicalTrials.gov ID: NCT05321563
Acronym / sponsor ID: iDECIDE / 2021P002611
Conditions: Adolescent Behavior, Substance Use, Youth, Health Risk Behaviors
Keywords: Diversion Program, Adolescent Substance Use, Middle and High School Students, Indicated Early Intervention, Tier 2 Services, School-Based Intervention
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to changes in state policy, the need for a comprehensive Tier 2 diversion program became apparent. The PI and Project Officer at MA DPH opened up programming statewide and updated the evaluation plan (NCT06115746).
Enrolment: 132 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Massachusetts Department of Health
Study start: 4 Feb 2022 (actual)
Primary completion: 14 Sep 2023 (actual)
Study completion: 14 Sep 2023 (actual)
First posted: 11 Apr 2022 (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 evaluate the effectiveness of the iDECIDE curriculum as an alternative to punitive responses for school-based substance use infractions.

Detailed description

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: This is a type 1, hybrid effectiveness-implementation trial using a stepped wedge design with stratified, clustered randomization. Investigators will randomly allocate the timing of implementation of the iDECIDE curriculum compared to standard disciplinary response, over approximately 24 months. Schools will cross over from control (i.e., standard disciplinary response) to intervention (i.e., iDECIDE curriculum) with all schools exposed to iDECIDE by the end of the trial.

Arm	Type	Receives
Observation Phase	No intervention	–Schools will continue to apply their standard disciplinary response to school-based substance use infractions during the 'unexposed' study period.
Intervention Phase	Experimental	Behavioral: iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)Schools will have the opportunity to deliver the iDECIDE curriculum in lieu of or as part of the standard disciplinary response to school-based substance use infractions during the 'exposed' study period.

Who may qualify

Ages: 10 to 22 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (10 listed)

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.
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)

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
iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)iDECIDE is a 4 session curriculum that addresses topics such as the neurobiology of substance use, adolescent brain development, industry tactics, motivations for using substances, risk and protective factors, triggers, healthy alternatives, core values, and long-term goal setting. These topics are taught via facilitated discussions, videos, worksheets, and handouts. Facilitators are selected by schools and community agencies to receive free trainings conducted by the iDECIDE team, which includes personnel from the Massachusetts Department of Public Health, Massachusetts General Hospital (MGH) Center for Addiction Medicine, and the Institute for Health and Recovery.	Behavioural	Intervention Phase

Primary outcome

Knowledge of drug effects from baseline to 90 day follow-up
Time frame: 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
Time frame: 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.

1 secondary outcome

Emotional support from baseline to 90 day follow-up
Time frame: Baseline - 90 days

Results and safety

The study was stopped early (reason given: Due to changes in state policy, the need for a comprehensive Tier 2 diversion program became apparent. The PI and Project Officer at MA DPH opened up programming statewide and updated the evaluation plan (NCT06115746).). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
Background: PubMed 37670822Gray CA, Iroegbulem V, Deming B, Butler R, Howell D, Pascale MP, Bodolay A, Potter K, Turncliff A, Lynch S, Whittaker J, Ward J, Maximus D, Pachas GN, Schuster RM. A pragmatic clinical effectiveness trial of a novel alternative to punishment for school-based substance use infractions: study protocol for the iDECIDE curriculum. Front Public Health. 2023 Aug 21;11:1203558. doi: 10.3389/fpubh.2023.1203558. eCollection 2023.
Curriculum WebpageLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Individual participant data that underlie reported results (after deidentification [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.

Randi M Schuster, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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: stopped early, as of the sponsor's last update on 5 Dec 2024. 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?

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 from baseline to 90 day follow-up (time frame: Baseline - 90 days). The study lists 2 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 NCT05321563, which also lists 1 linked publication.

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 Dec 2024.