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Pilot of a Drug Education Curriculum for Middle and High School Students (iDECIDE)

30 oktober 2026 bijgewerkt door: Randi Melissa Schuster, Massachusetts General Hospital

Development of a Drug Education Curriculum for Middle and High School Students

The goal of this pilot study is to measure the feasibility, sustainability, and acceptability of a drug education curriculum (IDECIDE) in middle and high students who have endorsed past-month substance use.The main question it aims to answer is:

1) What is the impact of iDECIDE on the the knowledge of drug effects and teen brain development, attitudes and perceptions of drug-related harms, and willingness to quit or reduce substance use?

Participants will be asked to participate in 4 sessions of the iDECIDE curriculum and complete surveys and interview questionnaires over the course of approximately 3 months.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study will be a one-arm pilot study enrolling approximately 100 middle and high school students who have endorsed substance use in the past month. Participants will be followed over 3 months. All participants will receive iDECIDE developed to provide behavioral support and psychoeducation via videoconference or in-person visits. The purpose of iDECIDE is to provide students with the knowledge and skills they need to make healthy decisions regarding substance use. Data collection will occur during seven visits over the span of approximately three months, including one baseline visit, four weekly visits during the intervention phase of the study, and then two follow-up visits. The follow-up visits will occur at approximately one week and one month following the end-of-intervention. Participants will complete questionnaires and assessments throughout the study. Primary outcomes (Knowledge of Drug Effects and Brain Development readiness to quit, readiness to reduce, perceptions of harm) will be assessed at visit 1 (baseline), visit 6 (one week follow-up), and visit 7 (one month follow-up). Participants will be compensated for session attendance.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

48

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02114
        • Massachusetts General Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Children and adolescents who are currently enrolled in middle or high school;
  • Have currently used (i.e., at least once in the past 30 days) any substance without a prescription;
  • Have a parent or legal guardian who is able and willing to provide written informed consent for the active study phase (if under the age of 18);
  • Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
  • Competent and able to provide written informed consent (if age 18 or older);
  • Able to communicate in English language;
  • Able to commit to 7 study visits in approximately 2 months;
  • Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator;
  • Has access to a reliable internet connection and a device that can run Zoom.

Exclusion Criteria:

  • Ever been in substance use treatment;
  • Ever engaged in IV drug use;
  • Current daily alcohol, or daily non-medical benzodiazepine and/or opioid use.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: iDECIDE

Participants will…

  1. Receive 4 weekly sessions of the iDECIDE drug curriculum.
  2. Complete assessments and questionnaires, including self-reports of substance use.
Gedragsmatig: iDECIDE

iDECIDE is a 4-session drug education and diversion program that addresses topics such as the neurobiology and addiction, adolescent brain development, industry tactics, motives for using substances, risk and protective factors, identifying triggers, healthy alternatives, core values, and long-term goal setting. These topics are taught via facilitated discussions, videos, worksheets, and handouts. The iDECIDE drug curriculum will be delivered weekly for 4 weeks via videoconference or in-person visits. Each session typically takes 60-75 minutes. For this study, facilitators are members of study staff.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Knowledge of Drug Effects & Brain Development
Tijdsspanne: Baseline, one-week follow-up, one-month follow-up

Knowledge of Drug Effects and Brain Development will be measured by number of items correct on a 25-item multiple-choice questionnaire that assesses knowledge taught in the iDECIDE curriculum, including neurobiology of addiction, side effects of substance, and industry tactics to market substances to young audiences.
Baseline, one-week follow-up, one-month follow-up
Readiness to Quit or Reduce Substance Use
Tijdsspanne: Baseline, one-week follow-up, one-month follow-up

Participants will complete a Readiness Ruler to determine how ready they are to quit and reduce their primary substance on a scale from 1 (not at all ready) to 10 (very ready).
Baseline, one-week follow-up, one-month follow-up
Perceived Harm of Substance Use
Tijdsspanne: Baseline, one-week follow-up, one-month follow-up

The Perceived Harm of Substance Use measure was modified from the 2010 National Survey on Drug Use and Health. Participants will assess their perceived harm of various forms of substance use using four response categories that range from no risk to great risk.
Baseline, one-week follow-up, one-month follow-up

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Frequency of Substance Use
Tijdsspanne: Baseline, one-week follow-up, one-month follow-up

The Timeline Follow-Back (TLFB) will be used to measure number of days the participant used a substance, which substances were used, and the frequency of which substances were used. The initial TLFB at the baseline visit will measure substances used in the past 90 days. Participants will be prompted to share their substance use since their baseline and follow-up visits during the one-week and one-month follow-up visits, respectively.
Baseline, one-week follow-up, one-month follow-up

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anxiety symptoms
Tijdsspanne: Baseline, one-week follow-up, one-month follow-up

The Screen for Child Anxiety Related Emotional Disorders Revised (SCARED-R) questionnaire is a 66-item self-report questionnaire to measure DSM child anxiety symptoms. Participants are asked to endorse how frequently they have experienced each symptom on a 3-point scale: 0 ("almost never"), 1 ("sometimes"), and 2 ("often"). A total score (0-132) and anxiety sub-scores are calculated by adding item scores.
Baseline, one-week follow-up, one-month follow-up
Depressive symptoms
Tijdsspanne: Baseline, one-week follow-up, one-month follow-up

The Center for Epidemiological Studies Depression Scale for Children (CES-DC) is a 20-item questionnaire for assessing past-week depressive symptoms in children and adolescents. Responses range from 0 ("not at all") to 3 ("a lot"). Total scores can range from 0-60.
Baseline, one-week follow-up, one-month follow-up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Massachusetts General Hospital

Medewerkers

Massachusetts Department of Health

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 maart 2021

Primaire voltooiing (Werkelijk)

11 juli 2025

Studie voltooiing (Werkelijk)

11 juli 2025

Studieregistratiedata

Eerst ingediend

30 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 oktober 2026

Eerst geplaatst (Werkelijk)

5 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2020P000727
  • INTF2300H78500224179 (Ander subsidie-/financieringsnummer: Massachusetts Department of Public Health)
  • INTF2400H78500224455 (Ander subsidie-/financieringsnummer: Massachusetts Department of Public Health)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Individual participant data that underlie reported results (after de-identification [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.

IPD-tijdsbestek voor delen

Beginning 3 months and ending 5 years following article publication

IPD-toegangscriteria voor delen

Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data access agreement required.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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