Opioid Misuse
Conditions
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.
Interventions
BEHAVIORALPlaySmart
Participants played the developed PlaySmart game over the course of a week.
BEHAVIORALPlaySmart Storyline
Participants played through one PlaySmart Storyline during one 1-1.5 hour session.
BEHAVIORALPlay Smart Mini-Game
Participants played through all levels of the PlaySmart Risk Sense mini-game during one 1-1.5 hour session.
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge Questions | Post Gameplay, up to 1 week | Participants were asked 5 true/false knowledge questions pre/post gameplay. |
| Perception of Risk of Harm | 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. |
| Gameplay Experience | 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. |
| Beta Test a Storyline of PlaySmart Game | 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. |
| Beta Test PlaySmart Risk Sense Mini Game | 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. |
| Beta Test PlaySmart Full Game: Character Development Focus | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: 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. | 3 |
| Experimental: 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. | 4 |
| Experimental: 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. | 4 |
| Experimental: 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. | 4 |
| Experimental: 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. | 4 |
| Experimental: 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. | 4 |
| Experimental: 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. | 4 |
| Experimental: 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. | 3 |
| Experimental: 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 | 3 |
| Total | 33 |
Baseline characteristics
| Characteristic | Experimental: A Friend in Need Storyline | Experimental: Grandma's Pills Storyline | Experimental: Tough Love Storyline | Experimental: Lean on Me Storyline | Experimental: PlaySmart Full Game | Experimental: Trading Wisdom Storyline | Experimental: A New Direction Storyline | Experimental: Risk Sense All Levels | Experimental: PlaySmart Full Game: Focus on Character Development | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 17.25 years | 16.5 years | 16.5 years | 16.5 years | 17 years | 17 years | 17 years | 16.6 years | 17 years | 16.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Knowledge Questions | — | — | — | — | 80 Percentage of Questions Correct STANDARD_DEVIATION 0 | — | — | — | — | 80 Percentage of Questions Correct STANDARD_DEVIATION 0 |
| Perception of Risk of Harm Questions | — | — | — | — | 2.8 units on a scale | — | — | — | — | 2.8 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 4 Participants | 2 Participants | 0 Participants | 1 Participants | 11 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 4 participants | 4 participants | 3 participants | 4 participants | 4 participants | 3 participants | 3 participants | 33 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 3 Participants | 4 Participants | 1 Participants | 1 Participants | 21 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 3 | 0 / 3 |
Outcome results
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.
Time frame: Post Gameplay, up to 1.5 hour
Population: Included are participants who did not play the full game.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PlaySmart Full Game | Beta Test a Storyline of PlaySmart Game | 4 Participants |
| Lean on Me Storyline | Beta Test a Storyline of PlaySmart Game | 4 Participants |
| Tough Love Storyline | Beta Test a Storyline of PlaySmart Game | 4 Participants |
| Grandma's Pills Storyline | Beta Test a Storyline of PlaySmart Game | 4 Participants |
| A Friend in Need Storyline | Beta Test a Storyline of PlaySmart Game | 4 Participants |
| A New Direction Storyline | Beta Test a Storyline of PlaySmart Game | 4 Participants |
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.
Time frame: Post Gameplay, up to 1 week
Population: 3 participants were randomly selected
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PlaySmart Full Game | Beta Test PlaySmart Full Game: Character Development Focus | 3 Participants |
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.
Time frame: Post Gameplay, up to 1.5 hour
Population: 3 participants were randomly selected
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PlaySmart Full Game | Beta Test PlaySmart Risk Sense Mini Game | 3 Participants |
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.
Time frame: Post Gameplay, up to 1 week
Population: Only 3 participants played the full game.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PlaySmart Full Game | Gameplay Experience | I felt like I was in control of the game. | 3.33 Rating on a Scale |
| PlaySmart Full Game | Gameplay Experience | I felt frustrated while playing PlaySmart. | 2.67 Rating on a Scale |
| PlaySmart Full Game | Gameplay Experience | I found PlaySmart confusing to use. | 2 Rating on a Scale |
| PlaySmart Full Game | Gameplay Experience | I liked the art and design of PlaySmart. | 4.67 Rating on a Scale |
| PlaySmart Full Game | Gameplay Experience | I understood the stories in PlaySmart. | 3 Rating on a Scale |
| PlaySmart Full Game | Gameplay Experience | I was absorbed in the experience. | 3.33 Rating on a Scale |
| PlaySmart Full Game | Gameplay Experience | Playing PlaySmart was interesting. | 4 Rating on a Scale |
| PlaySmart Full Game | Gameplay Experience | This game helped me. | 3.67 Rating on a Scale |
Primary
Knowledge Questions
Participants were asked 5 true/false knowledge questions pre/post gameplay.
Time frame: Post Gameplay, up to 1 week
Population: Only 3 participants played the full game.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PlaySmart Full Game | Knowledge Questions | 100 Percentage of Questions Correct | Standard Deviation 0 |
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.
Time frame: Post Gameplay, up to 1 week
Population: Only 3 participants played the full game
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PlaySmart Full Game | Perception of Risk of Harm | 1 score on a scale |