Brief Summary

This study's specific aims were to: develop a digital intervention as a prevention intervention through focus groups with 40 youth; pilot-test the developed digital intervention with 30 adolescents, using methods from the investigator's prior research; develop implementation strategies and partners through focus groups with 50 School Based Health Alliance affiliates and 30 adolescents from an Advisory Council.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

September 27, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed

1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed

10 months until next milestone

Results Posted

Study results publicly available

July 8, 2022

Completed

Last Updated

July 8, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

September 27, 2019

Results QC Date

January 26, 2022

Last Update Submit

June 15, 2022

Conditions

Opioid Misuse

Outcome Measures

Primary Outcomes (6)

Knowledge Questions
Participants were asked 5 true/false knowledge questions pre/post gameplay.
Post Gameplay, up to 1 week
Perception of Risk of Harm
Participants were asked 5 perception of harm questions then asked to rate the questions on a 4-point scale (no risk to great risk). Change in perception of risk of harm pre/post gameplay was measured to assess this outcome.
Post Gameplay, up to 1 week
Gameplay Experience
Gameplay experience was assessed using 8 statements to be rated on a scale of 1-5 (1= Not at all, 5= A lot) such as "I was absorbed in this experience" and "I understood the stories in PlaySmart." Each item was assessed individually to assess gameplay experience.
Post Gameplay, up to 1 week
Beta Test a Storyline of PlaySmart Game
Each storyline was randomly tested by 4 users and they provided qualitative feedback during focus groups post gameplay. Presented are counts of participants that successfully completed this task.
Post Gameplay, up to 1.5 hour
Beta Test PlaySmart Risk Sense Mini Game
Each level of the Risk Sense mini game was randomly tested by 3 users and they provided qualitative feedback during focus groups post gameplay. Presented are counts of participants that successfully completed this task.
Post Gameplay, up to 1.5 hour
Beta Test PlaySmart Full Game: Character Development Focus
The PlaySmart Full Game was randomly tested by 3 users and they provided qualitative feedback during focus groups post gameplay focused on character development. Presented are counts of participants that successfully completed the task.
Post Gameplay, up to 1 week

Study Arms (9)

PlaySmart Full Game

EXPERIMENTAL

Adolescents, boys and girls, aged 16-19 participated in the pilot testing of the adapted game. PlaySmart is a digital intervention targeted towards preventing opioid misuse in older adolescents.

Behavioral: PlaySmart

Trading Wisdom Storyline

EXPERIMENTAL

Adolescents, boys and girls, aged 16-19 participated in beta testing this PlaySmart storyline where the player receives an opioid prescription from their dentist. This storyline includes information about safe use of opioids and the difference between use and misuse.