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

Study Overview
=================
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/fentanyl.

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.

Official Title
-----------------
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers (Randomized Controlled Trial)

Conditions
-----------------
Opioid Misuse

Intervention / Treatment
-----------------
* Behavioral: PlaySmart
* Other: Video Game Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must: 1) preferably be enrolled in their high school's School-Based Health Center; 2) report NOT having engaged in any prior opioid misuse; 3) 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); 4) be willing to sit for 60 minutes/session to play the game; 5) be able to provide assent/parental/guardian consent (if under age 18). Exclusion Criteria: Failure to meet any of the inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PlaySmart<br>Video game intervention. | Behavioral: PlaySmart<br>* 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.<br>|
| Other: Control Game<br>Control video game intervention. | Other: Video Game Control<br>* Participants in the control group will play another video game with no intended effect similar to PlaySmart.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perception of Risk | 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. This outcome will be measured at baseline, after 6 weeks of gameplay, and at 3, 6, and 12 months after baseline. | Baseline, 6 weeks, 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intentions to Misuse Opioids (p2P Lab Questions) | 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. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Change in Self Efficacy for Refusing Opioids (p2P Lab Questions) | 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. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Change in Prevention of Initiation of Opioid Misuse (p2P Lab Questions) | 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. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Change in Knowledge about opioid misuse and its risks and mental health (p2P Lab Questions) | The outcomes will be assessed by determining a change in knowledge. Data analysis forthcoming. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Change in Attitudes to Misuse Opioids (p2P Lab Questions) | The outcomes will be assessed by determining a change in attitudes towards misuse opioids. Data analysis forthcoming. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Change in Perceived Norms About Opioid Misuse (p2P Lab Questions) | The outcomes will be assessed by determining a change in perceived norms towards misuse opioids. Data analysis forthcoming. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Decision-Making Skills (p2P Lab Questions) | The outcomes will be assessed by determining a change in decision-making skills. Data analysis forthcoming. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Self-Regulation (Across Time-TRAIT DERS) (p2P Lab Questions) | Data analysis forthcoming. | Baseline | 
| Self-Regulation (In a specific moment-STATE DERS) (p2P Lab Questions) | The outcomes will be assessed by determining a change in self-regulation. Data analysis forthcoming. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Help-Seeking Behavior (Past) (p2P Lab Questions) | The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Help Seeking Behavior (General) (p2P Lab Questions) | The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Self-Stigma of Seeking Help Scale (p2P Lab Questions) | The outcomes will be assessed by determining a change in self-stigma of seeking help. Data analysis forthcoming. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Beliefs About Psychological Services (p2P Lab Questions) | The outcomes will be assessed by determining a change in beliefs about psychological services. Data analysis forthcoming. | Baseline, 6 weeks, 3, 6, and 12 months | 
| Gameplay Experience (p2P Lab Questions) | Data analysis forthcoming | 6 weeks | 
| Gameplay Usability (p2P Lab Questions) | Data analysis forthcoming | 6 weeks | 
| Gameplay Engagement (p2P Lab Questions) | Data analysis forthcoming | 6 weeks | 
| Involvement with Legally Manufactured Opioids (Coordinating Center Questions) | The outcomes will be assessed by a change in involvement with legally manufactured opioids. Data analysis forthcoming | Baseline, 6 weeks, 3, 6, and 12 months | 
| Involvement with Illegally Manufactured Opioids (Coordinating Center Questions) | The outcomes will be assessed by a change in involvement with illegally manufactured opioids. Data analysis forthcoming | Baseline, 6 weeks, 3, 6, and 12 months | 
| Involvement with Alcohol (Coordinating Center Questions) | The outcomes will be assessed by a change in involvement with alcohol. Data analysis forthcoming | Baseline, 6 weeks, 3, 6, and 12 months | 
| Involvement with Marijuana (Coordinating Center Questions) | The outcomes will be assessed by a change in involvement with marijuana. Data analysis forthcoming | Baseline, 6 weeks, 3, 6, and 12 months | 
| Self-Efficacy (Coordinating Center Questions) | Data analysis forthcoming | Baseline, 6 weeks, 3, 6, and 12 months | 
| Mental Health (Depression - PHQ-8) (Coordinating Center Questions) | Data analysis forthcoming | Baseline, 6 weeks, 3, 6, and 12 months | 
| Mental Health (Anxiety - GAD-7) (Coordinating Center Questions) | Data analysis forthcoming | Baseline, 6 weeks, 3, 6, and 12 months | 
| Experience with Pain (Coordinating Center Questions) | Data analysis forthcoming | Baseline, 6 weeks, 3, 6, and 12 months | 
| Social Exposure to Substance Misuse (Exposure to Drugs and Alcohol) (Coordinating Center Questions) | Data analysis forthcoming | Baseline, 6 weeks, 3, 6, and 12 months |