A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
- Conditions
- Opioid Misuse
- Interventions
- Other: Video Game ControlBehavioral: PlaySmart
- Registration Number
- NCT04941950
- Lead Sponsor
- Trustees of Dartmouth College
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 533
- Participants must:
-
- preferably be enrolled in their high school's School-Based Health Center;
-
- report NOT having engaged in any prior opioid misuse;
-
- be at "high-risk" based on their report at baseline of past 30-day use of cigarettes, e-cigarettes, Juul, alcohol, marijuana (including synthetics), amphetamine, cocaine, benzodiazepines, ecstasy, bath salts, or any other misuse of non-opioid prescription drugs or use of non-opioid illicit drugs OR have a score of ≥1 on the PHQ-2 OR a score of ≥1 on the GAD-2 (both screening tools used by SBHA);
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- be willing to sit for 60 minutes/session to play the game;
-
- be able to provide assent/parental/guardian consent (if under age 18).
- Failure to meet any of the inclusion criteria.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Game Video Game Control Control video game intervention. PlaySmart PlaySmart Video game intervention.
- Primary Outcome Measures
Name Time Method Perception of Risk 3 months Perceived risk was measured by the question, "How much do you think people risk harming themselves (physically or in other ways), if they..." try or use a drug. For example, "...try marijuana once or twice." The answer categories are "no risk," "slight risk," "moderate risk," "great risk," and "can't say, drug unfamiliar." Parallel questions refer to using the same drug "occasionally" and "regularly." It is an 8 item, 4-point Likert scale. Total score range from 0-24. Higher scores mean greater perception of risk.
Change in Perception of Risk Baseline, 6 weeks, 3, 6, and 12 months Perceived risk was measured by the question, "How much do you think people risk harming themselves (physically or in other ways), if they..." try or use a drug. For example, "...try marijuana once or twice." The answer categories are "no risk," "slight risk," "moderate risk," "great risk," and "can't say, drug unfamiliar." Parallel questions refer to using the same drug "occasionally" and "regularly." It is an 8 item, 4-point Likert scale. Total score range from 0-24. Higher scores mean greater perception of risk. This outcome will be measured at baseline, after 6 weeks of gameplay, and at 3, 6, and 12 months after baseline.
- Secondary Outcome Measures
Name Time Method Self-Regulation (In a specific moment-STATE DERS) (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining a change in self-regulation. Data analysis forthcoming.
Self-Regulation (Across Time-TRAIT DERS) (p2P Lab Questions) Baseline Data analysis forthcoming.
Change in Intentions to Misuse Opioids (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining if there was a change in intentions to misuse opioids from baseline after 6 weeks of gameplay, and at 3, 6, and 12 months after baseline. The self-reported data questions were derived from the Monitoring the Future Study. Each item uses a 5-point scale to assess various facets of opioid misuse.
Change in Self Efficacy for Refusing Opioids (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining if there was a change in self-efficacy to refuse offers of opioids from baseline after 6 weeks of gameplay and at 3,6, and 12 months after baseline. This will be collected by self-reported data using questions from a study on preventing drug abuse among adolescents. It is a four-item scale for self-efficacy and relates to adolescent's perceived ability to resist pressure to use substances.
Change in Attitudes to Misuse Opioids (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining a change in attitudes towards misuse opioids. Data analysis forthcoming.
Involvement with Legally Manufactured Opioids (Coordinating Center Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by a change in involvement with legally manufactured opioids. Data analysis forthcoming
Change in Prevention of Initiation of Opioid Misuse (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining if a change in substance use behaviors (including prescription and illicit drugs, tobacco, and alcohol) occurred from baseline after 6 weeks of gameplay, and 3, 6, and 12 months after baseline. Self- reported data will be collected using questions from the Monitoring the Future Study.
Change in Perceived Norms About Opioid Misuse (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining a change in perceived norms towards misuse opioids. Data analysis forthcoming.
Beliefs About Psychological Services (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining a change in beliefs about psychological services. Data analysis forthcoming.
Involvement with Marijuana (Coordinating Center Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by a change in involvement with marijuana. Data analysis forthcoming
Mental Health (Anxiety - GAD-7) (Coordinating Center Questions) Baseline, 6 weeks, 3, 6, and 12 months Data analysis forthcoming
Change in Knowledge about opioid misuse and its risks and mental health (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining a change in knowledge. Data analysis forthcoming.
Decision-Making Skills (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining a change in decision-making skills. Data analysis forthcoming.
Help Seeking Behavior (General) (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming.
Gameplay Usability (p2P Lab Questions) 6 weeks Data analysis forthcoming
Mental Health (Depression - PHQ-8) (Coordinating Center Questions) Baseline, 6 weeks, 3, 6, and 12 months Data analysis forthcoming
Help-Seeking Behavior (Past) (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming.
Gameplay Engagement (p2P Lab Questions) 6 weeks Data analysis forthcoming
Self-Efficacy (Coordinating Center Questions) Baseline, 6 weeks, 3, 6, and 12 months Data analysis forthcoming
Experience with Pain (Coordinating Center Questions) Baseline, 6 weeks, 3, 6, and 12 months Data analysis forthcoming
Self-Stigma of Seeking Help Scale (p2P Lab Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by determining a change in self-stigma of seeking help. Data analysis forthcoming.
Gameplay Experience (p2P Lab Questions) 6 weeks Data analysis forthcoming
Involvement with Illegally Manufactured Opioids (Coordinating Center Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by a change in involvement with illegally manufactured opioids. Data analysis forthcoming
Involvement with Alcohol (Coordinating Center Questions) Baseline, 6 weeks, 3, 6, and 12 months The outcomes will be assessed by a change in involvement with alcohol. Data analysis forthcoming
Social Exposure to Substance Misuse (Exposure to Drugs and Alcohol) (Coordinating Center Questions) Baseline, 6 weeks, 3, 6, and 12 months Data analysis forthcoming
Trial Locations
- Locations (15)
Harding High School
🇺🇸Bridgeport, Connecticut, United States
Coginchaug High School
🇺🇸Durham, Connecticut, United States
CT River Academy
🇺🇸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
New London High School
🇺🇸New London, Connecticut, United States
Stamford High School
🇺🇸Stamford, Connecticut, United States
Westhill High School
🇺🇸Stamford, Connecticut, United States
Academy of Information, Technology, and Engineering
🇺🇸Stamford, Connecticut, United States
West Haven High School
🇺🇸West Haven, Connecticut, United States