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| ID | Type | Description | Link |
|---|---|---|---|
| INTF2300H78500224179 | Other Grant/Funding Number | Massachusetts Department of Public Health | |
| INTF2400H78500224455 | Other Grant/Funding Number | Massachusetts Department of Public Health |
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Due to changes in state policy, the need for a comprehensive Tier 2 diversion program became apparent. The PI and Project Officer at MA DPH opened up programming statewide and updated the evaluation plan (NCT06115746).
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| Name | Class |
|---|---|
| Massachusetts Department of Health | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
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:
Exclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randi M Schuster, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37670822 | Background | 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. |
| Label | URL |
|---|---|
| Curriculum Webpage | View source |
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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.
Beginning 3 months and ending 5 years following article publication
To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement.
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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.
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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.
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| Baseline - 90 days |
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D019966 | Substance-Related Disorders |
| D000073599 | Health Risk Behaviors |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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