A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
2 other identifiers
interventional
533
1 country
15
Brief Summary
The primary hypothesis of this study is that at 3 months, there will be a higher proportion of intervention participants vs. control participants who report greater risk of harm from misuse of prescription opioids AND heroin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedStudy Start
First participant enrolled
October 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedResults Posted
Study results publicly available
April 24, 2026
CompletedJuly 1, 2026
May 1, 2026
3.4 years
June 23, 2021
December 2, 2025
June 29, 2026
Conditions
Study Arms (2)
PlaySmart
EXPERIMENTALVideo game intervention.
Control Game
OTHERControl video game intervention.
Interventions
Participants in the control group will play another video game with no intended effect similar to PlaySmart.
PlaySmart is designed to provide players with behavioral skills and knowledge through repetitive and engaging videogame play to target adolescent perception of risk of harm from initiating opioid misuse.
Eligibility Criteria
You may qualify if:
- Participants must:
- \) preferably be enrolled in their high school's School-Based Health Center;
- \) report NOT having engaged in any prior opioid misuse;
- \) be at "high-risk" based on their report at baseline of past 30-day use of cigarettes, e-cigarettes, Juul, alcohol, marijuana (including synthetics), amphetamine, cocaine, benzodiazepines, ecstasy, bath salts, or any other misuse of non-opioid prescription drugs or use of non-opioid illicit drugs OR have a score of ≥1 on the PHQ-2 OR a score of ≥1 on the GAD-2 (both screening tools used by SBHA);
- \) be willing to sit for 60 minutes/session to play the game;
- \) be able to provide assent/parental/guardian consent (if under age 18).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute on Drug Abuse (NIDA)collaborator
- Tyra Boomerlead
Study Sites (15)
Harding High School
Bridgeport, Connecticut, 06610, United States
Coginchaug High School
Durham, Connecticut, 06422, United States
CT River Academy
East Hartford, Connecticut, 06118, United States
Fairfield College Preparatory School
Fairfield, Connecticut, 06824, United States
Fitch High School
Groton, Connecticut, 06340, United States
Hamden High School
Hamden, Connecticut, 06514, United States
Weaver High School
Hartford, Connecticut, 06112, United States
Maloney High School
Meriden, Connecticut, 06450, United States
Platt High School
Meriden, Connecticut, 06450, United States
Hopkins High School
New Haven, Connecticut, 06515, United States
New London High School
New London, Connecticut, 06320, United States
Stamford High School
Stamford, Connecticut, 06902, United States
Westhill High School
Stamford, Connecticut, 06902, United States
Academy of Information, Technology, and Engineering
Stamford, Connecticut, 06905, United States
West Haven High School
West Haven, Connecticut, 06516, United States
Related Publications (2)
Boomer T, Hoerner L, Larkin K, Maciejewski K, Kyriakides TC, Fiellin LE. A videogame for perceived risk of harm from opioid misuse in adolescents: a randomized controlled trial. Nat Health. 2026;1(1):78-89. doi: 10.1038/s44360-025-00010-z. Epub 2025 Dec 1.
PMID: 41635738DERIVEDPendergrass Boomer TM, Hoerner LA, Fernandes CF, Maslar A, Aiudi S, Kyriakides TC, Fiellin LE. A digital health game to prevent opioid misuse and promote mental health in adolescents in school-based health settings: Protocol for the PlaySmart game randomized controlled trial. PLoS One. 2023 Sep 8;18(9):e0291298. doi: 10.1371/journal.pone.0291298. eCollection 2023.
PMID: 37683047DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn E Fiellin, MD
Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy Director, play2PREVENT Lab
Study Record Dates
First Submitted
June 23, 2021
First Posted
June 28, 2021
Study Start
October 21, 2021
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
July 1, 2026
Results First Posted
April 24, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- HEAL Prevention Cooperative (HPC) data is anticipated to be archived in May 2026.
- Access Criteria
- The HEAL Coordinating Center will provide HPC data as well as supporting documentation for the HPC Common Measures as well as data that are uniquely collected as part of each HPC Research Project. The NAHDAP repository disseminates data to users based on its Access Policy Framework. Researchers who are not part of the HCP will be able to download HPC datasets and analyze them on their own computers. Access to data requires submission of username, institution, and analytic purpose and aim. There is no formal approval process initially planned by NIDA. Data users are expected to adhere to norms for responsible use.
The plan will comply with the NIH HEAL Initiative ClinicalTrials.govSM Public Access and Data Sharing Policy, NIH Data Sharing Policy, NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, and NIH Clinical Trial Registration and Results Information Submission rule. All IPD will be in a repository supported by NIDA, the NAHDAP, following NIH requirements for sharing data via creation of public-use data sets. Data will be de-identified/masked to minimize risk of potential re-identification to participants. This may include modification of the original data to reduce risk of re-identification of participants. A structured process will evaluate the risk of re-identification based on guidance documents from the US DHHS, HIPAA, and quantitative evaluation of the data using statistical methods. Potential revisions to the data to prepare them for NAHDAP include omission of variables, collapsing of categories of a variable, or other coarsening of specific participants' values.