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

Opioid Misuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109599
• Other study ID #: 2000026247
• Secondary ID: 1UG3DA050251-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: June 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Misuse
• Opioid-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge Questions	Participants were asked 5 true/false knowledge questions pre/post gameplay.	Post Gameplay, up to 1 week
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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