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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04941950
Other study ID # 2000030553
Secondary ID 1UG3DA050251-01
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 19, 2021
Est. completion date March 2025

Study information

Verified date March 2024
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 533
Est. completion date March 2025
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 19 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PlaySmart
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.
Other:
Video Game Control
Participants in the control group will play another video game with no intended effect similar to PlaySmart.

Locations

Country Name City State
United States Harding High School Bridgeport Connecticut
United States Coginchaug High School Durham Connecticut
United States CT River Academy East Hartford 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 Academy of Information, Technology, and Engineering Stamford Connecticut
United States Stamford High School Stamford Connecticut
United States Westhill High School Stamford Connecticut
United States West Haven High School West Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Self-Regulation (Across Time-TRAIT DERS) (p2P Lab Questions) Data analysis forthcoming. Baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Gameplay Experience (p2P Lab Questions) Data analysis forthcoming 6 weeks
Secondary Gameplay Usability (p2P Lab Questions) Data analysis forthcoming 6 weeks
Secondary Gameplay Engagement (p2P Lab Questions) Data analysis forthcoming 6 weeks
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Self-Efficacy (Coordinating Center Questions) Data analysis forthcoming Baseline, 6 weeks, 3, 6, and 12 months
Secondary Mental Health (Depression - PHQ-8) (Coordinating Center Questions) Data analysis forthcoming Baseline, 6 weeks, 3, 6, and 12 months
Secondary Mental Health (Anxiety - GAD-7) (Coordinating Center Questions) Data analysis forthcoming Baseline, 6 weeks, 3, 6, and 12 months
Secondary Experience with Pain (Coordinating Center Questions) Data analysis forthcoming Baseline, 6 weeks, 3, 6, and 12 months
Secondary Social Exposure to Substance Misuse (Exposure to Drugs and Alcohol) (Coordinating Center Questions) Data analysis forthcoming Baseline, 6 weeks, 3, 6, and 12 months
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