search
Back to results

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

Primary Purpose

Opioid Misuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PlaySmart
PlaySmart Storyline
Play Smart Mini-Game
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Misuse

Eligibility Criteria

16 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

PlaySmart Full Game

Trading Wisdom Storyline

Lean on Me Storyline

Tough Love Storyline

Grandma's Pills Storyline

A Friend in Need Storyline

A New Direction Storyline

Risk Sense All Levels

PlaySmart Full Game: Focus on Character Development

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Knowledge Questions
Participants were asked 5 true/false knowledge questions pre/post gameplay.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2019
Last Updated
June 15, 2022
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04109599
Brief Title
A Digital Intervention to Prevent Initiation of Opioid Misuse in Adolescents in School-based Health Centers
Official Title
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Misuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PlaySmart Full Game
Arm Type
Experimental
Arm Description
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.
Arm Title
Trading Wisdom Storyline
Arm Type
Experimental
Arm Description
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.
Arm Title
Lean on Me Storyline
Arm Type
Experimental
Arm Description
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.
Arm Title
Tough Love Storyline
Arm Type
Experimental
Arm Description
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.
Arm Title
Grandma's Pills Storyline
Arm Type
Experimental
Arm Description
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.
Arm Title
A Friend in Need Storyline
Arm Type
Experimental
Arm Description
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.
Arm Title
A New Direction Storyline
Arm Type
Experimental
Arm Description
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.
Arm Title
Risk Sense All Levels
Arm Type
Experimental
Arm Description
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.
Arm Title
PlaySmart Full Game: Focus on Character Development
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PlaySmart
Intervention Description
Participants played the developed PlaySmart game over the course of a week.
Intervention Type
Behavioral
Intervention Name(s)
PlaySmart Storyline
Intervention Description
Participants played through one PlaySmart Storyline during one 1-1.5 hour session.
Intervention Type
Behavioral
Intervention Name(s)
Play Smart Mini-Game
Intervention Description
Participants played through all levels of the PlaySmart Risk Sense mini-game during one 1-1.5 hour session.
Primary Outcome Measure Information:
Title
Knowledge Questions
Description
Participants were asked 5 true/false knowledge questions pre/post gameplay.
Time Frame
Post Gameplay, up to 1 week
Title
Perception of Risk of Harm
Description
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.
Time Frame
Post Gameplay, up to 1 week
Title
Gameplay Experience
Description
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.
Time Frame
Post Gameplay, up to 1 week
Title
Beta Test a Storyline of PlaySmart Game
Description
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.
Time Frame
Post Gameplay, up to 1.5 hour
Title
Beta Test PlaySmart Risk Sense Mini Game
Description
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.
Time Frame
Post Gameplay, up to 1.5 hour
Title
Beta Test PlaySmart Full Game: Character Development Focus
Description
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.
Time Frame
Post Gameplay, up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn E Fiellin, MD
Organizational Affiliation
Director, play2PREVENT Lab at Yale, Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs