The primary hypothesis of this study is that at 3 months, there will be a higher proportion of intervention participants vs. control participants who report greater risk of harm from misuse of prescription opioids AND heroin.
This study's specific aims are to: Conduct a randomized controlled trial with 532 high-risk adolescents in 10 School Based Health Centers (SBHCs), to compare PlaySmart to attention/time control games, with assessments post- gameplay (6 weeks), and at 3, 6, and 12 months following enrollment to determine if PlaySmart: 1) increases proportion of participants who report a perception of great risk of harm from misuse of opioids at 3 months; and 2) decreases intentions to misuse opioids; 3) increases self-efficacy for refusing opioids; 4) prevents initiation of opioid misuse, at all time-points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
533
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.
Participants in the control group will play another video game with no intended effect similar to PlaySmart.
Harding High School
Bridgeport, Connecticut, United States
Coginchaug High School
Durham, Connecticut, United States
CT River Academy
Percentage Reporting 'Great Perceived Risk of Harm' From Opioid Misuse
Perceived risk of harm from opioid misuse was assessed using eight items adapted from the U.S. Monitoring the Future survey. Five items assess perceived risk associated with heroin use and three items assess perceived risk associated with prescription opioid misuse. Participants were asked how much risk people have of harming themselves (physically or in other ways) if they use the drug once or twice, occasionally, or regularly. Response options were "no risk," "slight risk," "moderate risk," "great risk," and "can't say, drug unfamiliar." Items were scored from 1 to 4 (no risk = 1, slight risk = 2, moderate risk = 3, great risk = 4). Item scores were summed to create a total perceived risk score (range 8-32), with scores \<32 indicating "no great perceived risk of harm" and scores=32 indicating "great perceived risk of harm." The primary outcome was defined as the percentage of participants who reported "great perceived risk of harm" from opioids (score=32) at 3 months.
Time frame: 3 months
Intentions to Misuse Opioids (p2P Lab Questions)
Intentions to misuse opioids were assessed using 2-4 items adapted from Skenderian et. al. capturing participants' likelihood of using prescription opioids or heroin in the next 12 months. Two primary stem questions assessed likelihood of using (1) prescription opioids and (2) heroin "even once or time." For each substance, if participants endorsed any likelihood of use, a follow-up item assessed likelihood of using the same substance nearly every month for the next 12 months. Due to skip logic, participants who selected "definitely not" on the initial stem questions were not shown follow-up items. All items were rated on a 4-point Likert scale ranging from 1 (definitely not) to 4 (definitely will). Item responses were summed to create a total intentions score ranging from 2 to 16, with lower scores indicating lower intentions to misuse opioids. LS mean scores were estimated using mixed-effects models at each timepoint.
Time frame: Baseline, 6 weeks, 3, 6, and 12 months
Self Efficacy for Refusing Opioids (p2P Lab Questions)
Self-efficacy for refusing opioids was assessed using a two-item scale measuring participant's confidence in refusing prescription opioids or heroin if offered by a friend, adult or family member. Reponses were scored on a five-point scale ranging from 1 ("Not at all confident") to 5 ("Extremely confident") and summed across items to create a total score (range = 2-10), with higher scores indicating greater self-efficacy to refuse opioids. LS mean scores were estimated using mixed-effects models at each timepoint.
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East Hartford, Connecticut, United States
Fairfield College Preparatory School
Fairfield, Connecticut, United States
Fitch High School
Groton, Connecticut, United States
Hamden High School
Hamden, Connecticut, United States
Weaver High School
Hartford, Connecticut, United States
Maloney High School
Meriden, Connecticut, United States
Platt High School
Meriden, Connecticut, United States
Hopkins High School
New Haven, Connecticut, United States
...and 5 more locations
Time frame: Baseline, 6 weeks, 3, 6, and 12 months
Knowledge About Opioid Misuse and Its Risks (p2P Lab Questions)
Knowledge about opioids was assessed using a 30-item questionnaire measuring participants' understanding of opioid misuse and its risks. Each of the first 27 items was scored 1 point for a correct answer. The final 3 items were multiple-choice 'select all that apply' questions; participants received 1 point for each correct option selected. Total scores ranged from 0 to 38, with higher scores indicating greater knowledge about opioids. LS mean scores were estimated using mixed-effects models at each timepoint.
Time frame: Baseline, 6 weeks, 3, 6, and 12 months
Positive Attitudes Toward Opioid Misuse (p2P Lab Questions)
Attitudes about opioid use were assessed using a 15-item scale measuring positive and negative expectancies about using prescription opioids or heroin. Participants rated their agreement with statements such as "If I used prescription opioids or heroin, I would feel good" (positive expectancies) or "I would get in trouble with my parents" (negative expectancies) on a five-point scale from 0 ("Strongly disagree") to 4 ("Strongly agree"). Item scores were summed separately for positive and negative expectancies. The first 8 items represented positive expectancies (score range = 0-32). Higher scores indicate stronger expectancies. For positive expectancies, the goal of the intervention is to reduce scores. LS mean scores were estimated using mixed-effects models at each timepoint.
Time frame: Baseline, 6 weeks, 3, 6, and 12 months
Negative Attitudes Toward Opioid Misuse (p2P Lab Questions)
Attitudes about opioid use were assessed using a 15-item scale measuring positive and negative expectancies about using prescription opioids or heroin. Participants rated their agreement with statements such as "If I used prescription opioids or heroin, I would feel good" (positive expectancies) or "I would get in trouble with my parents" (negative expectancies) on a five-point scale from 0 ("Strongly disagree") to 4 ("Strongly agree"). Item scores were summed separately for positive and negative expectancies. The last 7 items represented negative expectancies (score range = 0-28). Higher scores indicate stronger expectancies. For negative expectancies, the goal is to increase scores. LS mean scores were estimated using mixed-effects models at each timepoint.
Time frame: Baseline, 6 weeks, 3, 6, and 12 months