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

Not Applicable

Completed

• Conditions: Opioid Misuse
• Interventions: Behavioral: PlaySmart; Behavioral: PlaySmart Storyline; Behavioral: Play Smart Mini-Game

• Registration Number: NCT04109599
• Lead Sponsor: Yale University

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.

Detailed Description

Most opioid misuse begins during adolescence and young adulthood. Adolescence is the time to intervene with prevention interventions (i.e., interventions focused on adolescents who have not yet misused opioids) in settings like school-based health centers (HCs), yet few interventions exist that prevent initiation of opioid misuse. "Serious videogame" interventions can improve health behaviors. They meet adolescents "where they are," and compared to standard interventions, they can reach large populations, with consistent fidelity, place limited demands on personnel/resources, and facilitate rapid sustainable distribution, all at a potentially lower cost.

This study harnessed the power of videogame interventions and incorporated components of effective substance use prevention programs to develop an evidence-informed intervention to prevent the initiation of opioid misuse in adolescents. Building on our experience developing videogame interventions and in partnership with the national School-Based Health Alliance (SBHA), we developed and tested a new videogame intervention, PlaySmart.

PlaySmart was built upon our PlayForward videogame intervention platform that has demonstrated efficacy in improving attitudes and knowledge related to risk behaviors. Through rigorous formative work and with input from adolescents, and our SBHA and game development partners, we created the PlaySmart videogame intervention.

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.

The gap in the research on preventing initiation of opioid misuse in youth and in implementing prevention programs with good fidelity needs to be urgently addressed given the high prevalence of adolescent opioid misuse and overdose. This research has the potential to create a videogame intervention to prevent initiation of opioid misuse with far-reaching and sustained impact on adolescents.

Study Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Study Start: 2021-03-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Results First Submitted: 2022-01-26
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-15
• Last Update Submitted: 2022-06-15
• Results First Posted: 2022-07-08
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Adolescent participants must attend high school that has a school-based health center, to participate in pilot testing

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Exclusion Criteria

• Failure to meet Inclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PlaySmart Full Game	PlaySmart	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.
Lean on Me Storyline	PlaySmart Storyline	Adolescents, boys and girls, aged 16-19 participated in beta testing this PlaySmart storyline where the player is offered opioids at a party. This storyline includes information about different forms of opioids and their effects.
Tough Love Storyline	PlaySmart Storyline	Adolescents, boys and girls, aged 16-19 participated in beta testing this PlaySmart storyline where the player navigates supporting their partner struggling with opioid misuse. This storyline includes information about treatment and recovery resources for opioid misuse \& Opioid Use Disorder.
Grandma's Pills Storyline	PlaySmart Storyline	Adolescents, boys and girls, aged 16-19 participated in beta testing this PlaySmart storyline where the player witnesses the sharing of an opioid prescription within their family. This storyline includes information about medication safety and opioid overdose identification and response.
Trading Wisdom Storyline	PlaySmart Storyline	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.
A New Direction Storyline	PlaySmart Storyline	Adolescents, boys and girls, aged 16-19 participated in beta testing this PlaySmart storyline where the player seeks out therapy as an option to manage stress. This storyline includes information about how to seek professional help for mental health.
A Friend in Need Storyline	PlaySmart Storyline	Adolescents, boys and girls, aged 16-19 participated in beta testing this PlaySmart storyline where the player interacts with a friend that is in distress. This storyline includes information about how to navigate peer-to-peer support.
Risk Sense All Levels	Play Smart Mini-Game	Adolescents, boys and girls, aged 16-19 participated in beta testing all levels of this PlaySmart mini game intended to increase perceived risk of harm of opioid misuse.
PlaySmart Full Game: Focus on Character Development	PlaySmart	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. Participants in this arm focused on beta testing character development aspects throughout the game.

Primary Outcome Measures

Name	Time	Method
Knowledge Questions	Post Gameplay, up to 1 week	Participants were asked 5 true/false knowledge questions pre/post gameplay.
Gameplay Experience	Post Gameplay, up to 1 week	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.
Perception of Risk of Harm	Post Gameplay, up to 1 week	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.
Beta Test PlaySmart Risk Sense Mini Game	Post Gameplay, up to 1.5 hour	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.
Beta Test a Storyline of PlaySmart Game	Post Gameplay, up to 1.5 hour	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.
Beta Test PlaySmart Full Game: Character Development Focus	Post Gameplay, up to 1 week	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.

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States