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

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Misuse
• Intervention / Treatment: Behavioral: PlaySmart; Other: Video Game Control

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.

• Study Type: Interventional
• Enrollment (Actual): 533
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Harding High School
    • Durham, Connecticut, United States, 06422
      • Coginchaug High School
    • East Hartford, Connecticut, United States, 06118
      • CT River Academy
    • Fairfield, Connecticut, United States, 06824
      • Fairfield College Preparatory School
    • Groton, Connecticut, United States, 06340
      • Fitch High School
    • Hamden, Connecticut, United States, 06514
      • Hamden High School
    • Hartford, Connecticut, United States, 06112
      • Weaver High School
    • Meriden, Connecticut, United States, 06450
      • Maloney High School
    • Meriden, Connecticut, United States, 06450
      • Platt High School
    • New Haven, Connecticut, United States, 06515
      • Hopkins High School
    • New London, Connecticut, United States, 06320
      • New London High School
    • Stamford, Connecticut, United States, 06902
      • Stamford High School
    • Stamford, Connecticut, United States, 06902
      • Westhill High School
    • Stamford, Connecticut, United States, 06905
      • Academy of Information, Technology, and Engineering
    • West Haven, Connecticut, United States, 06516
      • West Haven High School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PlaySmart; Video game 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: Control Game; Control video game intervention.	Other: Video Game Control; Participants in the control group will play another video game with no intended effect similar to PlaySmart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline, 6 weeks, 3, 6, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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 of heroin use and three items assess perceived risk of prescription opioid misuse. Participants were asked how much risk people have of harming themselves 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 (no risk) to 4 (great risk). Item scores were summed to create a total perceived risk score (range 8-32), with higher scores indicating greater perceived risk of harm. A dichotomous outcome was derived such that a total score of 32 indicated "great perceived risk of harm," and scores less than 32 indicated "no great perceived risk of harm." Outcome=% of respondents who changed status from "No great perceived risk" at baseline to "Great perceived risk" at 3-months.	3 months
Percent Reporting Involvement With Legally Manufactured Opioids (Coordinating Center Questions)	Lifetime use of prescription opioids was assessed by asking participants, "Have you ever used a prescription opioid without a doctor's prescription or differently than how a doctor or medical provider told you to use it?" at each timepoint. Response options were "Yes" or "No." Only participants who reported no prior misuse at baseline were included in analyses for this outcome. The outcome was defined as the percent of participants reporting any prescription opioid misuse (i.e. 'yes') at 6 weeks post-gameplay and at 3, 6, and 12 months following baseline.	Baseline, 6 weeks, 3, 6, and 12 months
Percent Reporting Involvement With Illegally Manufactured Opioids (Coordinating Center Questions)	Lifetime use of prescription opioids was assessed by asking participants, "Have you ever used heroin?" at each timepoint. Response options were "Yes" or "No." Only participants who reported no prior use at baseline were included in analyses for this outcome. The outcome was defined as the percent of participants reporting any use (i.e. 'yes') at 6 weeks post-gameplay and at 3, 6, and 12 months following baseline.	Baseline, 6 weeks, 3, 6, and 12 months
Gameplay Engagement (p2P Lab Questions)	Gameplay engagement was assessed using four self-report items evaluating participants' experiences while playing the PlaySmart game, including frustration during gameplay, sensory appeal, perceived reward, and interest in playing the game. Participants rated their agreement with each statement using a five-point Likert scale ranging from "Strongly disagree" to "Strongly agree." For positively worded items (e.g. "Playsmart was rewarding"), results are reported as the percentage of participants who responded 'Agree' or 'Strongly Agree.' For negatively worded items (e.g. "I felt frustrated"), results are reported as the percentage who responded 'Disagree' or 'Strongly Disagree.' Denominators include all participants who provided a response to the item.	6 weeks
Gameplay Experience (p2P Lab Questions)	Participants' experience with the PlaySmart game was assessed using six self-report items evaluating perceived learning, frustration, usability, character connection, control, and enjoyment. Example items include "This game helped me learn important things," "I felt frustrated while playing PlaySmart," and "I enjoyed playing the game." Participants rated their agreement on a five-point scale: "Strongly disagree," "Disagree," "Agree," "Strongly agree," or "Not sure." For positively worded items, results are reported as the percentage of participants who responded 'Agree' or 'Strongly Agree.' For negatively worded items, results are reported as the percentage who responded 'Disagree' or 'Strongly Disagree.' Denominators include all participants who provided a response to the item.	6 weeks
Gameplay Usability (p2P Lab Questions)	Participants' perceived usability of the PlaySmart game system was assessed using four self-report items evaluating perceived complexity, learnability, and confidence in using the game. Example items include "I found the game system to be complex," "I think that most people would learn to use this game system very quickly," and "I felt very confident using the game system." Participants rated their agreement using a five-point Likert scale: "Strongly disagree," "Disagree," "Neither agree nor disagree," "Agree," and "Strongly agree." Results are summarized as follows: for positively worded items (e.g., "I felt very confident using the game system"), the percentage of participants who responded Agree or Strongly Agree is reported; for negatively worded items (e.g., "I found the game system to be complex"), the percentage of participants who responded Disagree or Strongly Disagree is reported. Denominators include all participants who provided a response to the item.	6 weeks
Percent Reporting Involvement With Alcohol (Coordinating Center Questions)	Lifetime use of alcohol was assessed by asking participants, "Have you ever had at least one drink of alcohol?" at each timepoint. Response options were "Yes" or "No." The outcome was defined as the percent of participants reporting any alcohol use (i.e. 'yes') at 6 weeks post-gameplay and at 3-, 6-, and 12-months following baseline. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Percent Reporting Involvement With Marijuana (Coordinating Center Questions)	Lifetime use of marijuana was assessed by asking participants, "Have you ever used marijuana? Marijuana also is called pot, weed, or cannabis." at each timepoint. Response options were "Yes" or "No." The outcome was defined as the percent of participants reporting any marijuana use (i.e. 'yes') at 6 weeks post-gameplay and at 3-, 6-, and 12-months following baseline. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Mental Health (Depression - PHQ-8) (Coordinating Center Questions)	Depressive symptoms were assessed using the 8-item Patient Health Questionnaire (PHQ-8), which measures the frequency of depressive symptoms experienced over the past two weeks. Participants rated how often they were bothered by symptoms such as little interest or pleasure in doing things, feeling down or hopeless, sleep difficulties, fatigue, poor appetite or overeating, feelings of failure, difficulty concentrating, and psychomotor changes. Each item was scored from 0 ("Not at all") to 3 ("Nearly every day") and summed to create a total score ranging from 0 to 24, with higher scores indicating greater depressive symptom severity. Standard cut points were used to characterize symptom severity (0-4 = no significant symptoms; 5-9 = mild; 10-14 = moderate; 15-19 = moderately severe; 20-24 = severe). Data analysis forthcoming. Analyses will include participants with complete responses to all PHQ-8 items at each timepoint.	Baseline, 6 weeks, 3, 6, and 12 months
Mental Health (Anxiety - GAD-7) (Coordinating Center Questions)	Anxiety symptoms were assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7), which measures the frequency of anxiety symptoms experienced over the past two weeks. Participants rated how often they were bothered by symptoms such as feeling nervous or on edge, difficulty controlling worry, excessive worry, trouble relaxing, restlessness, irritability, and fear that something awful might happen. Each item was scored from 0 ("Not at all") to 3 ("Nearly every day") and summed to create a total score ranging from 0 to 21, with higher scores indicating greater anxiety symptom severity. Standard cut points were used to characterize symptom severity (0-4 = minimal; 5-9 = mild; 10-14 = moderate; 15-21 = severe). Data analysis forthcoming. Analyses will include participants with complete responses to all GAD-7 items at each timepoint.	Baseline, 6 weeks, 3, 6, and 12 months
Past Help-Seeking Behavior (p2P Lab Questions)	Participants were presented with a list of potential sources of support (e.g., friends, family members, adults, professionals) and were asked to indicate which individuals they sought help or advice from for a personal or emotional problem during the past 6 months. For each selected person, participants reported the number of times they met with that individual for advice or help during the past 6 months, using whole numbers. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Decision-Making Skills (p2P Lab Questions)	Participants reported on their problem-solving and decision-making behaviors using nine self-report items. Examples include: "I think about difficult situations that I might find myself in and make plans to deal with them." and "When there is a problem, I try to find out what caused it." Response options for each item were: "Never," "Seldom," "About Half the Time," "Often," and "Always," with higher responses indicating more frequent use of decision-making strategies. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Self-Stigma of Seeking Help (p2P Lab Questions)	Participants completed a ten-item self-report measure assessing attitudes toward seeking help for personal or emotional problems. For example, "I would feel inadequate if I went to a therapist for psychological help." Respondents were asked to use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree' to rate the degree to which each statement describes how they would react in the situation. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Perceived Peer Norms About Opioid Misuse (p2P Lab Questions)	Participants reported their perceptions of substance use among peers at their school. The following questions were asked: "How many kids in your school would you guess have misused prescription opioids at least once?" and "How many kids in your school would you guess have used heroin at least once?" Response options for each item were categorical: "All or Most," "Half," "Some," and "Hardly Any or None." Higher responses reflect perceptions that substance use is more common among peers. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Self-Regulation (STATE DERS) (p2P Lab Questions)	Participants were asked to indicate how they have been feeling emotionally during the past week in response to ten statements which assess emotional regulation, emotional awareness, and perceived control over emotions and behavior. Responses were rated on a 5-point Likert scale: (a) Not at all (b) Somewhat (c) Moderately (d) Very much (e) Completely. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
General Help Seeking Behavior (p2P Lab Questions)	Participants were asked how likely they would be to seek help for a personal or emotional problem from a range of potential help sources, including informal supports (e.g., intimate partner, friends, family), formal supports (e.g., mental health professionals, doctor/GP, phone helpline), and other sources (e.g., religious leaders). Participants also indicated whether they would not seek help from anyone. Responses were provided on a 7-point Likert-type scale ranging from Extremely unlikely to Extremely likely. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Beliefs About Psychological Services (p2P Lab Questions)	Participants completed 18 self-report true/false questions assessing their beliefs about seeking psychological services. Example item includes "If a good friend asked my advice about a serious problem, I would recommend that he/she see a psychologist." Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Self-Efficacy (Coordinating Center Questions)	Self-efficacy for refusing opioids was assessed using a two-item scale measuring participant's confidence in refusing prescription opioids or heroin if they had access to it. Reponses ranged from 1 ("Not at all confident") to 5 ("Extremely confident"). Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Experience With Pain (Coordinating Center Questions)	Participants reported how pain affected their daily functioning and emotions over the past 7 days, using four self-report items adapted from Cunningham et al. (2017) and Varni et al. (2010). Response options for each item were: "Never," "Almost Never," "Sometimes," "Often," and "Almost Always," with higher responses indicating greater impact of pain on function or mood. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months
Social Exposure to Substance Misuse (Exposure to Drugs and Alcohol) (Coordinating Center Questions)	Participants reported their perceptions of substance use among people who live with them. The following questions were asked: "What is the most often that one person who lives with you drinks alcohol?"; "What is the most often that one person who lives with you uses marijuana?"; and "What is the most often that one person who lives with you uses heroin?" Response options for each item were: "Never," "Less than once a week," "1-3 days a week," and "4-7 days a week," with higher responses indicating more frequent substance use by household members. Analysis forthcoming.	Baseline, 6 weeks, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Trustees of Dartmouth College
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Lynn E Fiellin, MD, Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College

Publications and helpful links

General Publications

• Boomer T, Hoerner L, Larkin K, Maciejewski K, Kyriakides TC, Fiellin LE. A videogame for perceived risk of harm from opioid misuse in adolescents: a randomized controlled trial. Nat Health. 2026;1(1):78-89. doi: 10.1038/s44360-025-00010-z. Epub 2025 Dec 1.
• Pendergrass Boomer TM, Hoerner LA, Fernandes CF, Maslar A, Aiudi S, Kyriakides TC, Fiellin LE. A digital health game to prevent opioid misuse and promote mental health in adolescents in school-based health settings: Protocol for the PlaySmart game randomized controlled trial. PLoS One. 2023 Sep 8;18(9):e0291298. doi: 10.1371/journal.pone.0291298. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2000030553; 1UG3DA050251-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The plan will comply with the NIH HEAL Initiative ClinicalTrials.govSM Public Access and Data Sharing Policy, NIH Data Sharing Policy, NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, and NIH Clinical Trial Registration and Results Information Submission rule. All IPD will be in a repository supported by NIDA, the NAHDAP, following NIH requirements for sharing data via creation of public-use data sets. Data will be de-identified/masked to minimize risk of potential re-identification to participants. This may include modification of the original data to reduce risk of re-identification of participants. A structured process will evaluate the risk of re-identification based on guidance documents from the US DHHS, HIPAA, and quantitative evaluation of the data using statistical methods. Potential revisions to the data to prepare them for NAHDAP include omission of variables, collapsing of categories of a variable, or other coarsening of specific participants' values.
• IPD Sharing Time Frame: HEAL Prevention Cooperative (HPC) data is anticipated to be archived in May 2026.
• IPD Sharing Access Criteria: The HEAL Coordinating Center will provide HPC data as well as supporting documentation for the HPC Common Measures as well as data that are uniquely collected as part of each HPC Research Project. The NAHDAP repository disseminates data to users based on its Access Policy Framework. Researchers who are not part of the HCP will be able to download HPC datasets and analyze them on their own computers. Access to data requires submission of username, institution, and analytic purpose and aim. There is no formal approval process initially planned by NIDA. Data users are expected to adhere to norms for responsible use.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No