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

NCT05321563 | Terminated

• 3 other identifiers: 2021P002611INTF2300H78500224179INTF2400H78500224455
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Emotional support from baseline to 90 day follow-up

  Baseline - 90 days

Study Arms (2)

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.

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

Interventions

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

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.

Intervention Phase

Eligibility Criteria

• Age: 10 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Currently enrolled in a participating middle or high school;
• Provide informed assent/consent for participation in this research by voluntarily completing the survey.
• 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.
• Enrolled in the iDECIDE curriculum by a trained iDECIDE facilitator.
• Unable to adequately read and respond to survey items in one of the languages available.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Department of Health: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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.

  PMID: 37670822 BACKGROUND

Related Links

• Curriculum Webpage

MeSH Terms

Conditions

Adolescent Behavior; Substance-Related Disorders; Health Risk Behaviors

Condition Hierarchy (Ancestors)

Behavior; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Study Officials

• Randi M Schuster, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 11, 2022
• Study Start: February 4, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement.

Locations

US (1)