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

Adolescent Behavior Clinical Trial

— iDECIDE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05321563
• Other study ID #: 2021P002611
• Secondary ID: INTF2300H7850022
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 4, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: June 30, 2024
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 22 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Health Risk Behaviors
• Substance Use
• Substance-Related Disorders
• Youth

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Massachusetts Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline - 90 days
Primary	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.	Baseline - 90 days
Secondary	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.	Baseline - 90 days

External Links

•   Curriculum Webpage