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

Trustees of Dartmouth College

Status: Completed

Conditions: Opioid Misuse

Treatments: Behavioral: PlaySmart; Other: Video Game Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04941950

1UG3DA050251-01 (U.S. NIH Grant/Contract)

2000030553

Details and patient eligibility

About

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.

Full 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.

Enrollment: 533 patients

Sex: All

Ages: 16 to 19 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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533 participants in 2 patient groups

PlaySmart

Experimental group

Description:

Video game intervention.

Treatment:

Behavioral: PlaySmart

Control Game

Other group

Description:

Control video game intervention.

Treatment:

Other: Video Game Control