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

Primary Purpose

Adolescent Behavior, Substance Use, Youth

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adolescent Behavior focused on measuring Diversion Program, Adolescent Substance Use, Middle and High School Students, Indicated Early Intervention, Tier 2 Services, School-Based Intervention

Eligibility Criteria

10 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Eligibility criteria for the primary aim (i.e., evaluating how student-level outcomes change when schools transition from a standard disciplinary response to having access to a more educational and therapeutic alternative):

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Exploratory Aim 3: Evaluating the feasibility and acceptability of the iDECIDE curriculum (School Stakeholder Interviews)

Inclusion Criteria:

  • Current school faculty members involved in school responses to substance use and/or planning or delivery of social-emotional supports at participating schools; or community members identified by the participating school to be trained in and deliver iDECIDE to school students;
  • Able to speak, read, and write comfortably in English;
  • Willing and able to provide verbal consent.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Observation Phase

Intervention Phase

Arm Description

Schools will continue to apply their standard disciplinary response to school-based substance use infractions during the 'unexposed' study period.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 18, 2022
Last Updated
October 20, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT05321563
Brief Title
Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School Students
Acronym
iDECIDE
Official Title
Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School Students
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 4, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Department of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observation Phase
Arm Type
No Intervention
Arm Description
Schools will continue to apply their standard disciplinary response to school-based substance use infractions during the 'unexposed' study period.
Arm Title
Intervention Phase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knowledge of drug effects from baseline to 90 day follow-up
Description
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.
Time Frame
Baseline - 90 days
Title
Frequency of substance use from baseline to 90 day follow-up
Description
Frequency of substance use will be operationalized as the number of days spent using student's preferred substance assessed via 14-day timeline followback.
Time Frame
Baseline - 90 days
Secondary Outcome Measure Information:
Title
Emotional support from baseline to 90 day follow-up
Description
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.
Time Frame
Baseline - 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility criteria for the primary aim (i.e., evaluating how student-level outcomes change when schools transition from a standard disciplinary response to having access to a more educational and therapeutic alternative): Inclusion Criteria: 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. Exclusion Criteria: 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. Exploratory Aim 3: Evaluating the feasibility and acceptability of the iDECIDE curriculum (School Stakeholder Interviews) Inclusion Criteria: Current school faculty members involved in school responses to substance use and/or planning or delivery of social-emotional supports at participating schools; or community members identified by the participating school to be trained in and deliver iDECIDE to school students; Able to speak, read, and write comfortably in English; Willing and able to provide verbal consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randi M Schuster, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement.
Links:
URL
http://www.idecidemyfuture.org
Description
Curriculum Webpage

Learn more about this trial

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

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