Back to resultsRandomized Controlled Trial: A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
Primary Purpose
Opioid Misuse
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PlaySmart
Video Game Control
Sponsored by
About this trial
This is an interventional prevention trial for Opioid Misuse
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.
Sites / Locations
- CT River AcademyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PlaySmart
Control Game
Arm Description
Video game intervention.
Control video game intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Decision-Making Skills (p2P Lab Questions)
The outcomes will be assessed by determining a change in decision-making skills. Data analysis forthcoming.
Self-Regulation (Across Time-TRAIT DERS) (p2P Lab Questions)
Data analysis forthcoming.
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.
Help-Seeking Behavior (Past) (p2P Lab Questions)
The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming.
Help Seeking Behavior (General) (p2P Lab Questions)
The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming.
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.
Beliefs About Psychological Services (p2P Lab Questions)
The outcomes will be assessed by determining a change in beliefs about psychological services. Data analysis forthcoming.
Gameplay Experience (p2P Lab Questions)
Data analysis forthcoming
Gameplay Usability (p2P Lab Questions)
Data analysis forthcoming
Gameplay Engagement (p2P Lab Questions)
Data analysis forthcoming
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
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
Involvement with Alcohol (Coordinating Center Questions)
The outcomes will be assessed by a change in involvement with alcohol. Data analysis forthcoming
Involvement with Marijuana (Coordinating Center Questions)
The outcomes will be assessed by a change in involvement with marijuana. Data analysis forthcoming
Self-Efficacy (Coordinating Center Questions)
Data analysis forthcoming
Mental Health (Depression - PHQ-8) (Coordinating Center Questions)
Data analysis forthcoming
Mental Health (Anxiety - GAD-7) (Coordinating Center Questions)
Data analysis forthcoming
Experience with Pain (Coordinating Center Questions)
Data analysis forthcoming
Social Exposure to Substance Misuse (Exposure to Drugs and Alcohol) (Coordinating Center Questions)
Data analysis forthcoming
Full Information
NCT ID
NCT04941950
First Posted
June 23, 2021
Last Updated
February 1, 2023
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04941950
Brief Title
Randomized Controlled Trial: A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
Official Title
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers (Randomized Controlled Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Misuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
532 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PlaySmart
Arm Type
Experimental
Arm Description
Video game intervention.
Arm Title
Control Game
Arm Type
Other
Arm Description
Control video game intervention.
Intervention Type
Behavioral
Intervention Name(s)
PlaySmart
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Video Game Control
Intervention Description
Participants in the control group will play another video game with no intended effect similar to PlaySmart.
Primary Outcome Measure Information:
Title
Change in Perception of Risk
Description
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.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Change in Intentions to Misuse Opioids (p2P Lab Questions)
Description
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.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Change in Self Efficacy for Refusing Opioids (p2P Lab Questions)
Description
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.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Change in Prevention of Initiation of Opioid Misuse (p2P Lab Questions)
Description
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.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Change in Knowledge about opioid misuse and its risks and mental health (p2P Lab Questions)
Description
The outcomes will be assessed by determining a change in knowledge. Data analysis forthcoming.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Change in Attitudes to Misuse Opioids (p2P Lab Questions)
Description
The outcomes will be assessed by determining a change in attitudes towards misuse opioids. Data analysis forthcoming.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Change in Perceived Norms About Opioid Misuse (p2P Lab Questions)
Description
The outcomes will be assessed by determining a change in perceived norms towards misuse opioids. Data analysis forthcoming.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Decision-Making Skills (p2P Lab Questions)
Description
The outcomes will be assessed by determining a change in decision-making skills. Data analysis forthcoming.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Self-Regulation (Across Time-TRAIT DERS) (p2P Lab Questions)
Description
Data analysis forthcoming.
Time Frame
Baseline
Title
Self-Regulation (In a specific moment-STATE DERS) (p2P Lab Questions)
Description
The outcomes will be assessed by determining a change in self-regulation. Data analysis forthcoming.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Help-Seeking Behavior (Past) (p2P Lab Questions)
Description
The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Help Seeking Behavior (General) (p2P Lab Questions)
Description
The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Self-Stigma of Seeking Help Scale (p2P Lab Questions)
Description
The outcomes will be assessed by determining a change in self-stigma of seeking help. Data analysis forthcoming.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Beliefs About Psychological Services (p2P Lab Questions)
Description
The outcomes will be assessed by determining a change in beliefs about psychological services. Data analysis forthcoming.
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Gameplay Experience (p2P Lab Questions)
Description
Data analysis forthcoming
Time Frame
6 weeks
Title
Gameplay Usability (p2P Lab Questions)
Description
Data analysis forthcoming
Time Frame
6 weeks
Title
Gameplay Engagement (p2P Lab Questions)
Description
Data analysis forthcoming
Time Frame
6 weeks
Title
Involvement with Legally Manufactured Opioids (Coordinating Center Questions)
Description
The outcomes will be assessed by a change in involvement with legally manufactured opioids. Data analysis forthcoming
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Involvement with Illegally Manufactured Opioids (Coordinating Center Questions)
Description
The outcomes will be assessed by a change in involvement with illegally manufactured opioids. Data analysis forthcoming
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Involvement with Alcohol (Coordinating Center Questions)
Description
The outcomes will be assessed by a change in involvement with alcohol. Data analysis forthcoming
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Involvement with Marijuana (Coordinating Center Questions)
Description
The outcomes will be assessed by a change in involvement with marijuana. Data analysis forthcoming
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Self-Efficacy (Coordinating Center Questions)
Description
Data analysis forthcoming
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Mental Health (Depression - PHQ-8) (Coordinating Center Questions)
Description
Data analysis forthcoming
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Mental Health (Anxiety - GAD-7) (Coordinating Center Questions)
Description
Data analysis forthcoming
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Experience with Pain (Coordinating Center Questions)
Description
Data analysis forthcoming
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
Title
Social Exposure to Substance Misuse (Exposure to Drugs and Alcohol) (Coordinating Center Questions)
Description
Data analysis forthcoming
Time Frame
Baseline, 6 weeks, 3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lynn E Fiellin, MD
Phone
(203) 737-3347
Email
lynn.sullivan@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lily Hoerner
Email
lily.hoerner@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn E Fiellin, MD
Organizational Affiliation
Director, Yale Center for Health & Learning Games, Internal Medicine; Director, play2PREVENT Lab at Yale, Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
CT River Academy
City
East Hartford
State/Province
Connecticut
ZIP/Postal Code
06118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mallory Breitmaier
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Randomized Controlled Trial: A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
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