A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
NCT ID: NCT04941950
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
533 participants
INTERVENTIONAL
2021-10-19
2025-03-01
Brief Summary
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Detailed Description
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Conduct a randomized controlled trial with 532 high-risk adolescents in 10 School Based Health Centers (SBHCs), to compare PlaySmart to attention/time control games, with assessments post- gameplay (6 weeks), and at 3, 6, and 12 months following enrollment to determine if PlaySmart: 1) increases proportion of participants who report a perception of great risk of harm from misuse of opioids at 3 months; and 2) decreases intentions to misuse opioids; 3) increases self-efficacy for refusing opioids; 4) prevents initiation of opioid misuse, at all time-points.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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PlaySmart
Video game intervention.
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.
Control Game
Control video game intervention.
Video Game Control
Participants in the control group will play another video game with no intended effect similar to PlaySmart.
Interventions
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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.
Video Game Control
Participants in the control group will play another video game with no intended effect similar to PlaySmart.
Eligibility Criteria
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Inclusion Criteria
* 1\) preferably be enrolled in their high school's School-Based Health Center;
* 2\) report NOT having engaged in any prior opioid misuse;
* 3\) 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);
* 4\) be willing to sit for 60 minutes/session to play the game;
* 5\) be able to provide assent/parental/guardian consent (if under age 18).
16 Years
19 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Trustees of Dartmouth College
OTHER
Responsible Party
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Principal Investigators
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Lynn E Fiellin, MD
Role: PRINCIPAL_INVESTIGATOR
Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College
Locations
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Harding High School
Bridgeport, Connecticut, United States
Coginchaug High School
Durham, Connecticut, United States
CT River Academy
East Hartford, Connecticut, United States
Fairfield College Preparatory School
Fairfield, Connecticut, United States
Fitch High School
Groton, Connecticut, United States
Hamden High School
Hamden, Connecticut, United States
Weaver High School
Hartford, Connecticut, United States
Maloney High School
Meriden, Connecticut, United States
Platt High School
Meriden, Connecticut, United States
Hopkins High School
New Haven, Connecticut, United States
New London High School
New London, Connecticut, United States
Stamford High School
Stamford, Connecticut, United States
Westhill High School
Stamford, Connecticut, United States
Academy of Information, Technology, and Engineering
Stamford, Connecticut, United States
West Haven High School
West Haven, Connecticut, United States
Countries
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References
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Pendergrass 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.
Other Identifiers
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2000030553
Identifier Type: -
Identifier Source: org_study_id
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