Clinical trial NCT04109599: 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
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Misuse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-09-30
Enrollment: 33
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Knowledge Questions
timeFrame: Post Gameplay, up to 1 week
measure: Perception of Risk of Harm
timeFrame: Post Gameplay, up to 1 week
measure: Gameplay Experience
timeFrame: Post Gameplay, up to 1 week
measure: Beta Test a Storyline of PlaySmart Game
timeFrame: Post Gameplay, up to 1.5 hour
measure: Beta Test PlaySmart Risk Sense Mini Game
timeFrame: Post Gameplay, up to 1.5 hour
measure: Beta Test PlaySmart Full Game: Character Development Focus
timeFrame: Post Gameplay, up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Director, play2PREVENT Lab at Yale, Internal Medicine
name: Lynn E Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References: