Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-31 @ 6:12 PM
Study NCT ID:
NCT04941950
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
Sponsor:
Trustees of Dartmouth College
Organization:
Study Overview
Official Title:
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers (Randomized Controlled Trial)
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1UG3DA050251-01 | NIH | None | https://reporter.nih.gov/quic… | View |