A Digital Intervention to Prevent Initiation of Opioid Misuse in Adolescents in School-based Health Centers
NCT ID: NCT04109599
Last Updated: 2022-07-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
33 participants
INTERVENTIONAL
2021-03-01
2021-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
NCT04941950
Organization-level Youth Engagement Approach for Substance Misuse Prevention
NCT05736211
Using Technology to Reduce Youth Substance Use
NCT04446910
Prevention of Substance Use in At-Risk Students: A Family-Centered Web Program
NCT03060291
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
NCT05209191
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PlaySmart Full Game
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.
PlaySmart
Participants played the developed PlaySmart game over the course of a week.
Trading Wisdom 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.
PlaySmart Storyline
Participants played through one PlaySmart Storyline during one 1-1.5 hour session.
Lean on Me 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.
PlaySmart Storyline
Participants played through one PlaySmart Storyline during one 1-1.5 hour session.
Tough Love 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.
PlaySmart Storyline
Participants played through one PlaySmart Storyline during one 1-1.5 hour session.
Grandma's Pills 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.
PlaySmart Storyline
Participants played through one PlaySmart Storyline during one 1-1.5 hour session.
A Friend in Need 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.
PlaySmart Storyline
Participants played through one PlaySmart Storyline during one 1-1.5 hour session.
A New Direction 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.
PlaySmart Storyline
Participants played through one PlaySmart Storyline during one 1-1.5 hour session.
Risk Sense All Levels
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.
Play Smart Mini-Game
Participants played through all levels of the PlaySmart Risk Sense mini-game during one 1-1.5 hour session.
PlaySmart Full Game: Focus on Character Development
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.
PlaySmart
Participants played the developed PlaySmart game over the course of a week.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PlaySmart
Participants played the developed PlaySmart game over the course of a week.
PlaySmart Storyline
Participants played through one PlaySmart Storyline during one 1-1.5 hour session.
Play Smart Mini-Game
Participants played through all levels of the PlaySmart Risk Sense mini-game during one 1-1.5 hour session.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
16 Years
19 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lynn E Fiellin, MD
Role: PRINCIPAL_INVESTIGATOR
Director, play2PREVENT Lab at Yale, Internal Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale School of Medicine
New Haven, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2000026247
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.