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

Mass General Brigham

Status: Invitation-only

Conditions: Substance Use; Youth; Health Risk Behaviors; Adolescent Behavior

Treatments: Behavioral: iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)

Study type: Interventional

Funder types: Other

Identifiers

NCT05321563

INTF2400H78500224455 (Other Grant/Funding Number)

INTF2300H78500224179 (Other Grant/Funding Number)

2021P002611

Details and patient eligibility

About

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.

Full 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:

1. 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.
2. 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.
3. 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 10 to 22 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

Observation Phase

No Intervention group

Description:

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

Intervention Phase

Experimental group

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.

Treatment:

Behavioral: iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment)