Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT03489434
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2018-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Technology-Based Prevention for Adolescents in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'agilmore12@gsu.edu', 'phone': '404-413-2000', 'title': 'Amanda Gilmore', 'organization': 'Georgia State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored over the 6-month data collection period.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.\n\nIntervention: Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Assessment only control.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Enrollment and Recruitment Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.\n\nIntervention: Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Assessment only control.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 2 year recruitment period', 'description': 'Feasibility of enrollment recruitment was assessed by the proportion of anticipated participants enrolled in the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Retention Rate: Number of Participants Who Completed at Least 1 Follow-Up Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Retention for the intervention condition was calculated using the number of participants who completed at least one follow-up study.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Retention for the control condition was calculated using the number of participants who completed at least one follow-up study.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 6 months of baseline participation', 'description': 'Feasibility of retention was assessed by the proportion of participants retained in the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.\n\nIntervention: Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Assessment only control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.\n\nIntervention: Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Assessment only control.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.62', 'spread': '1.39', 'groupId': 'BG000'}, {'value': '15.63', 'spread': '1.24', 'groupId': 'BG001'}, {'value': '15.63', 'spread': '1.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Boy', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'Girl', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Nonbinary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Not listed or prefer not to answer', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latine', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Substance Use Risk', 'classes': [{'title': 'Alcohol', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Cannabis', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Tobacco or vaping', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Prescription drug misuse', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Illegal drugs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ever engaged in sex', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Substance use before sex in past 90 days', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-16', 'size': 607700, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-09T14:52', 'hasProtocol': True}, {'date': '2021-09-16', 'size': 277589, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-08T13:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participant and Investigator are blinded to condition'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2018-03-29', 'resultsFirstSubmitDate': '2024-08-01', 'studyFirstSubmitQcDate': '2018-03-29', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-30', 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment and Recruitment Rate', 'timeFrame': 'within 2 year recruitment period', 'description': 'Feasibility of enrollment recruitment was assessed by the proportion of anticipated participants enrolled in the study'}, {'measure': 'Retention Rate: Number of Participants Who Completed at Least 1 Follow-Up Study', 'timeFrame': 'within 6 months of baseline participation', 'description': 'Feasibility of retention was assessed by the proportion of participants retained in the study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adolescents', 'primary care', 'sexual assault', 'substance use', 'sexual risk behavior'], 'conditions': ['Substance Use']}, 'referencesModule': {'references': [{'pmid': '37917146', 'type': 'DERIVED', 'citation': 'Gilmore AK, Fortson K, Mullican KN, Garcia-Ramirez G, Hutchins A, Bartlett AM, Gooding HC, Wallis E, Levy S, Ruggiero KJ, Kaysen D, Danielson CK, Platner R, Hartman A, Self-Brown S. An eHealth Prevention Program for Substance Use, Sexual Assault, and Sexual Risk Behaviors for Adolescents in Primary Care: Pilot Feasibility Randomized Controlled Trial of Teen Well Check. JMIR Form Res. 2023 Nov 2;7:e50833. doi: 10.2196/50833.'}]}, 'descriptionModule': {'briefSummary': 'Adolescent substance use, sexual assault, and sexual risk behaviors pose a great public health concern, and subsequently there is also a great need to prevent these behaviors and experiences. This project involves the adaptation and integration of evidence-based prevention content aimed at preventing and reducing substance use, sexual assault, and sexual risk behaviors. This project uses innovative technology within primary care visits to conduct a feasibility trial of an integrated prevention program.', 'detailedDescription': 'Pilot feasibility trial in preparation for RCT. Adolescents aged 14-18 will be recruited for screening from community-based primary care clinics to ensure ease of dissemination and representation of community-based primary care settings. The primary goal is to develop feasibility to apply for an R01 to conduct an RCT. Power analyses indicate that 280 participants would be needed for an RCT after accounting for attrition. Given that the RCT would be conducted over a 3-year period, a recruitment rate of 8 adolescents per month would indicate feasibility for a larger RCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 14-18\n* Recent visit to primary care doctor\n\nExclusion Criteria:\n\n* Inability to comprehend English independently due to disability or language'}, 'identificationModule': {'nctId': 'NCT03489434', 'briefTitle': 'Technology-Based Prevention for Adolescents in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Georgia State University'}, 'officialTitle': 'Technology-Based Prevention for Adolescents in Primary Care', 'orgStudyIdInfo': {'id': 'H21524'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.', 'interventionNames': ['Behavioral: Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Assessment only control.'}], 'interventions': [{'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia State University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Amanda K Gilmore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgia State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgia State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Amanda Gilmore', 'investigatorAffiliation': 'Georgia State University'}}}}