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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3DA050251-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PlaySmart | Experimental | Video game intervention. |
|
| Control Game | Other | Control video game intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PlaySmart | Behavioral | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn E Fiellin, MD | Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harding High School | Bridgeport | Connecticut | 06610 | United States | ||
| Coginchaug High School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41635738 | Derived | 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. | |
| 37683047 | Derived | 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. |
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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.
HEAL Prevention Cooperative (HPC) data is anticipated to be archived in May 2026.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2023 |
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| Video Game Control | Other | Participants in the control group will play another video game with no intended effect similar to PlaySmart. |
|
| 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 |
| Dec 1, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2023 | Dec 1, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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