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

Study Overview
=================
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.

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

Conditions
-----------------
Opioid Misuse

Intervention / Treatment
-----------------
* Behavioral: PlaySmart
* Behavioral: PlaySmart Storyline
* Behavioral: Play Smart Mini-Game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent participants must attend high school that has a school-based health center, to participate in pilot testing Exclusion Criteria: Failure to meet Inclusion Criteria

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PlaySmart Full Game<br>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<br>* Participants played the developed PlaySmart game over the course of a week.<br>|
| Experimental: Trading Wisdom Storyline<br>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. | Behavioral: PlaySmart Storyline<br>* Participants played through one PlaySmart Storyline during one 1-1.5 hour session.<br>|
| Experimental: Lean on Me Storyline<br>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. | Behavioral: PlaySmart Storyline<br>* Participants played through one PlaySmart Storyline during one 1-1.5 hour session.<br>|
| Experimental: Tough Love Storyline<br>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. | Behavioral: PlaySmart Storyline<br>* Participants played through one PlaySmart Storyline during one 1-1.5 hour session.<br>|
| Experimental: Grandma's Pills Storyline<br>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. | Behavioral: PlaySmart Storyline<br>* Participants played through one PlaySmart Storyline during one 1-1.5 hour session.<br>|
| Experimental: A Friend in Need Storyline<br>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. | Behavioral: PlaySmart Storyline<br>* Participants played through one PlaySmart Storyline during one 1-1.5 hour session.<br>|
| Experimental: A New Direction Storyline<br>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. | Behavioral: PlaySmart Storyline<br>* Participants played through one PlaySmart Storyline during one 1-1.5 hour session.<br>|
| Experimental: Risk Sense All Levels<br>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. | Behavioral: Play Smart Mini-Game<br>* Participants played through all levels of the PlaySmart Risk Sense mini-game during one 1-1.5 hour session.<br>|
| Experimental: PlaySmart Full Game: Focus on Character Development<br>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. | Behavioral: PlaySmart<br>* Participants played the developed PlaySmart game over the course of a week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |