Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-31 @ 6:12 PM
Study NCT ID:
NCT04941950
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2021-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-16', 'releaseDate': '2025-12-02'}], 'estimatedResultsFirstSubmitDate': '2025-12-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 533}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2021-06-23', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perception of Risk', 'timeFrame': '3 months', '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. Total score range from 0-24. Higher scores mean greater perception of risk.'}, {'measure': 'Change in Perception of Risk', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', '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. 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.'}], 'secondaryOutcomes': [{'measure': 'Change in Intentions to Misuse Opioids (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', '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.'}, {'measure': 'Change in Self Efficacy for Refusing Opioids (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', '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."}, {'measure': 'Change in Prevention of Initiation of Opioid Misuse (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', '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.'}, {'measure': 'Change in Knowledge about opioid misuse and its risks and mental health (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by determining a change in knowledge. Data analysis forthcoming.'}, {'measure': 'Change in Attitudes to Misuse Opioids (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by determining a change in attitudes towards misuse opioids. Data analysis forthcoming.'}, {'measure': 'Change in Perceived Norms About Opioid Misuse (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by determining a change in perceived norms towards misuse opioids. Data analysis forthcoming.'}, {'measure': 'Decision-Making Skills (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by determining a change in decision-making skills. Data analysis forthcoming.'}, {'measure': 'Self-Regulation (Across Time-TRAIT DERS) (p2P Lab Questions)', 'timeFrame': 'Baseline', 'description': 'Data analysis forthcoming.'}, {'measure': 'Self-Regulation (In a specific moment-STATE DERS) (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by determining a change in self-regulation. Data analysis forthcoming.'}, {'measure': 'Help-Seeking Behavior (Past) (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming.'}, {'measure': 'Help Seeking Behavior (General) (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by determining a change in help-seeking behaviors. Data analysis forthcoming.'}, {'measure': 'Self-Stigma of Seeking Help Scale (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by determining a change in self-stigma of seeking help. Data analysis forthcoming.'}, {'measure': 'Beliefs About Psychological Services (p2P Lab Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by determining a change in beliefs about psychological services. Data analysis forthcoming.'}, {'measure': 'Gameplay Experience (p2P Lab Questions)', 'timeFrame': '6 weeks', 'description': 'Data analysis forthcoming'}, {'measure': 'Gameplay Usability (p2P Lab Questions)', 'timeFrame': '6 weeks', 'description': 'Data analysis forthcoming'}, {'measure': 'Gameplay Engagement (p2P Lab Questions)', 'timeFrame': '6 weeks', 'description': 'Data analysis forthcoming'}, {'measure': 'Involvement with Legally Manufactured Opioids (Coordinating Center Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by a change in involvement with legally manufactured opioids. Data analysis forthcoming'}, {'measure': 'Involvement with Illegally Manufactured Opioids (Coordinating Center Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by a change in involvement with illegally manufactured opioids. Data analysis forthcoming'}, {'measure': 'Involvement with Alcohol (Coordinating Center Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by a change in involvement with alcohol. Data analysis forthcoming'}, {'measure': 'Involvement with Marijuana (Coordinating Center Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'The outcomes will be assessed by a change in involvement with marijuana. Data analysis forthcoming'}, {'measure': 'Self-Efficacy (Coordinating Center Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'Data analysis forthcoming'}, {'measure': 'Mental Health (Depression - PHQ-8) (Coordinating Center Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'Data analysis forthcoming'}, {'measure': 'Mental Health (Anxiety - GAD-7) (Coordinating Center Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'Data analysis forthcoming'}, {'measure': 'Experience with Pain (Coordinating Center Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'Data analysis forthcoming'}, {'measure': 'Social Exposure to Substance Misuse (Exposure to Drugs and Alcohol) (Coordinating Center Questions)', 'timeFrame': 'Baseline, 6 weeks, 3, 6, and 12 months', 'description': 'Data analysis forthcoming'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Misuse']}, 'referencesModule': {'references': [{'pmid': '37683047', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "This study's specific aims are to:\n\nConduct 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must:\n* 1\\) preferably be enrolled in their high school\'s School-Based Health Center;\n* 2\\) report NOT having engaged in any prior opioid misuse;\n* 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);\n* 4\\) be willing to sit for 60 minutes/session to play the game;\n* 5\\) be able to provide assent/parental/guardian consent (if under age 18).\n\nExclusion Criteria:\n\n* Failure to meet any of the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT04941950', 'briefTitle': 'A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers', 'organization': {'class': 'OTHER', 'fullName': 'Trustees of Dartmouth College'}, 'officialTitle': 'A Digital Intervention to Prevent the Initiation of Opioid Misuse in Adolescents in School-based Health Centers (Randomized Controlled Trial)', 'orgStudyIdInfo': {'id': '2000030553'}, 'secondaryIdInfos': [{'id': '1UG3DA050251-01', 'link': 'https://reporter.nih.gov/quickSearch/1UG3DA050251-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PlaySmart', 'description': 'Video game intervention.', 'interventionNames': ['Behavioral: PlaySmart']}, {'type': 'OTHER', 'label': 'Control Game', 'description': 'Control video game intervention.', 'interventionNames': ['Other: Video Game Control']}], 'interventions': [{'name': 'PlaySmart', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['PlaySmart']}, {'name': 'Video Game Control', 'type': 'OTHER', 'description': 'Participants in the control group will play another video game with no intended effect similar to PlaySmart.', 'armGroupLabels': ['Control Game']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Harding High School', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06422', 'city': 'Durham', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Coginchaug High School', 'geoPoint': {'lat': 41.48176, 'lon': -72.68121}}, {'zip': '06118', 'city': 'East Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'CT River Academy', 'geoPoint': {'lat': 41.78232, 'lon': -72.61203}}, {'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Fairfield College Preparatory School', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '06340', 'city': 'Groton', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Fitch High School', 'geoPoint': {'lat': 41.3501, 'lon': -72.07841}}, {'zip': '06514', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hamden High School', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '06112', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Weaver High School', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06450', 'city': 'Meriden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Maloney High School', 'geoPoint': {'lat': 41.53815, 'lon': -72.80704}}, {'zip': '06450', 'city': 'Meriden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Platt High School', 'geoPoint': {'lat': 41.53815, 'lon': -72.80704}}, {'zip': '06515', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hopkins High School', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New London High School', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford High School', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Westhill High School', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Academy of Information, Technology, and Engineering', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '06516', 'city': 'West Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'West Haven High School', 'geoPoint': {'lat': 41.27065, 'lon': -72.94705}}], 'overallOfficials': [{'name': 'Lynn E Fiellin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director, play2PREVENT Lab & Professor, BDS at Geisel School of Medicine at Dartmouth College'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'HEAL Prevention Cooperative (HPC) data is anticipated to be archived in May 2026.', 'ipdSharing': 'YES', '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.", 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trustees of Dartmouth College', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-12-02', 'type': 'RELEASE'}, {'date': '2025-12-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Trustees of Dartmouth College'}}}}