Clinical trial NCT05321563: Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School Students
Official title: Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School Students
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Department of Health
First posted: 2022-04-11
Enrollment: 132
Sex: ALL
Minimum age (years): 10
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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:

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.

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.

Primary outcomes:
measure: Knowledge of drug effects from baseline to 90 day follow-up
timeFrame: Baseline - 90 days
measure: Frequency of substance use from baseline to 90 day follow-up
timeFrame: Baseline - 90 days
Secondary outcomes:
measure: Emotional support from baseline to 90 day follow-up
timeFrame: Baseline - 90 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Randi M Schuster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.