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A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers

A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers (Randomized Controlled Trial)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04941950
Enrollment
533
Registered
2021-06-28
Start date
2021-10-21
Completion date
2025-03-01
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Misuse

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.

Detailed description

This study's specific aims are to: 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.

Interventions

BEHAVIORALPlaySmart

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.

OTHERVideo Game Control

Participants in the control group will play another video game with no intended effect similar to PlaySmart.

Sponsors

Tyra Boomer
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

* Participants must: * 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).

Exclusion criteria

* Failure to meet any of the inclusion criteria.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLynn E Fiellin, MD

Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026