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Completed

NCT Number: NCT04109599

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

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.

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Key information

Conditions

Opioid Misuse Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PlaySmart

Behavioral

Participants played the developed PlaySmart game over the course of a week.

PlaySmart Storyline

Behavioral

Participants played through one PlaySmart Storyline during one 1-1.5 hour session.

Play Smart Mini-Game

Behavioral

Participants played through all levels of the PlaySmart Risk Sense mini-game during one 1-1.5 hour session.

Primary outcomes

  1. Knowledge Questions

    Time frame: Post Gameplay, up to 1 week

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

  2. Perception of Risk of Harm

    Time frame: Post Gameplay, up to 1 week

    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.

  3. Gameplay Experience

    Time frame: Post Gameplay, up to 1 week

    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.

  4. Beta Test a Storyline of PlaySmart Game

    Time frame: Post Gameplay, up to 1.5 hour

    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.

  5. Beta Test PlaySmart Risk Sense Mini Game

    Time frame: Post Gameplay, up to 1.5 hour

    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.

  6. Beta Test PlaySmart Full Game: Character Development Focus

    Time frame: Post Gameplay, up to 1 week

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 30, 2019
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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