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

  • STATUS
    Recruiting
  • End date
    Feb 3, 2024
  • participants needed
    532
  • sponsor
    Yale University
Updated on 3 July 2022
Accepts healthy volunteers

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/fentanyl.

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.

Details
Condition Opioid Misuse
Treatment PlaySmart, Video Game Control
Clinical Study IdentifierNCT04941950
SponsorYale University
Last Modified on3 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

Failure to meet any of the inclusion criteria
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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