Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-28 @ 9:50 PM
Study NCT ID:
NCT07207850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parents Helping Parents for Youth Vaping Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}, {'id': 'D000072137', 'term': 'Vaping'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012907', 'term': 'Smoking'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-10-01', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day point prevalence abstinence', 'timeFrame': 'Baseline and Follow ups (1 month, 3 months, 6 months)'}], 'secondaryOutcomes': [{'measure': 'Vaping frequency', 'timeFrame': 'Baseline and Follow ups (1 month, 3 months, 6 months)'}, {'measure': 'Past 7 day Vaping intensity', 'timeFrame': 'Baseline and Follow ups (1 month, 3 months, 6 months)', 'description': 'Self-reported vaping intensity will be assessed with the questions "In the past 7 days, on the days you vaped, how many times did you usually pick up your device to vape? "and "In the past 7 days, each time you pick up your vape, how many puffs do you usually take before putting it away?".'}, {'measure': 'Other tobacco use', 'timeFrame': 'Baseline and Follow ups (1 month, 3 months, 6 months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaping', 'Tobacco', 'vaping cessation', 'Parent support', 'adolescent vaping'], 'conditions': ['Implementation Science', 'Engagement, Patient', 'E Cigarette Use', 'Peer Support', 'Vaping Teens', 'Vaping Cessation', 'Parent Support']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled study is to test if this new intervention works to help adolescents quit vaping. A key feature of the program is the use of peer support for parents, delivered by trained parent coaches. Participants will complete baseline and follow up surveys. Parents in the intervention arm will receive peer support as part of the program.', 'detailedDescription': 'This objective of study is to develop and test the feasibility of a novel Parents-helping-Parents for Youth Vaping Cessation (PhP-VX) program. The investigators will conduct a feasibility pilot test with 100 parent-adolescent dyads recruited from an EHR system. Half of the dyads will receive the "PhP-VX" program for 3 months, and half of the dyads will be assigned to the control (no-treatment) group.\n\nThe PhP-VX program consists of two key components: 1) online lessons for participating parents and adolescents and 2) one on one sessions with a coach for parents.\n\nEligible dyads will be randomly assigned to either the test or control group using a computer-generated randomization list. At baseline, all participants will complete a survey assessing their e-cigarette and tobacco use, vaping knowledge, and exposure to marketing and media. Dyads assigned to the test arm will receive PhP-VX program instructions, and parents will be immediately connected with a coach. Parents will be scheduled to receive six bi-weekly, 30-minute, 1:1 coach-facilitated sessions via Zoom. The coaches will identify the priority needs of the participant, provide support and advocacy (e.g., coach on how to identify own needs and access resources), role model (e.g., share experiences, demonstrate effective decision-making), effective communication with their children, and facilitate change (motivation, facilitate change through goal setting/education/skills building). Parents will also be able to contact the coach as needed for additional support and resources.\n\nAll participants in both the control and test arms will be followed up at months 1, 3, and 6 with questions on e-cigarette use, vaping knowledge, and marketing/media literacy. Parents and children in the test arm will also complete an evaluation of the PhP-VX program at the end of the intervention (month 3).\n\nThe investigators will offer twenty adolescent participants (10 control, 10 intervention) the option to provide saliva samples at baseline, 3 months, and 6 months. The samples will be collected using the iScreen Oral Fluid Device (OFD) cotinine test, which detects cotinine, a metabolite of nicotine and the recommended biomarker for validating self-reported tobacco abstinence. Cotinine levels will serve as our biochemical verification of participants\' self-reported abstinence. Adolescents who agree to participate will receive saliva collection kits by mail. Participants will be instructed to upload a photo of their test result via a REDCap survey.\n\nParents and children in the control group, who receive no intervention during the study, will be given access to online training materials following the final follow-up at month 6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'ADOLESCENT INCLUSION:\n\n* 15-18\n* Report vaping in the previous 30 days\n* English literacy\n\nPARENT INCLUSION:\n\n* Biological, adoptive, stepparents, or adult guardian of adolescent participating\n* Have face-to-face contact with the adolescent at least one day per week during the study period\n* Access to a computer or mobile phone at home\n* Interested in helping adolescent quit e-cigarette/vape use'}, 'identificationModule': {'nctId': 'NCT07207850', 'acronym': 'PhP-VX', 'briefTitle': 'Parents Helping Parents for Youth Vaping Cessation', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Parents Helping Parents for Youth Vaping Cessation (PhP-VX)', 'orgStudyIdInfo': {'id': '0617-25-EP'}, 'secondaryIdInfos': [{'id': '1R34CA287719-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R34CA287719-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants in this arm will not receive the PhP-VX treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'Test Group - PHP-VX Program', 'description': 'Participants in this arm will receive the PhP-VX program.', 'interventionNames': ['Behavioral: Parents Helping Parents program']}], 'interventions': [{'name': 'Parents Helping Parents program', 'type': 'BEHAVIORAL', 'description': 'Our innovative vaping cessation program will include two key components: 1) online training for parents and their offspring, and 2) parent-helping-parent coach sessions. Parents and children in the control setting will receive no treatments during the intervention (Baseline to Month 3). Dyads will be provided online training materials after the 6 month follow up.', 'armGroupLabels': ['Test Group - PHP-VX Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198-4375', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'contacts': [{'name': 'Daisy Dai, PhD', 'role': 'CONTACT', 'email': 'daisy.dai@unmc.edu', 'phone': '4025595907'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'centralContacts': [{'name': 'Daisy Dai, PhD', 'role': 'CONTACT', 'email': 'daisy.dai@unmc.edu', 'phone': '402-559-5907'}]}, 'ipdSharingStatementModule': {'url': 'https://nda.nih.gov/', 'infoTypes': ['SAP'], 'timeFrame': 'Shared data generated from this project will be made available upon publications. The duration of preservation and sharing of the data will be a minimum of 10 years after the end of the funding period.', 'ipdSharing': 'YES', 'description': 'De-identified individual, aggregated, summarized data will be made available for sharing. To facilitate interpretation of the data, statistical analysis plans will be created, shared, and associated with the relevant datasets.', 'accessCriteria': 'Summary information on the data shared in NDA is available in the NDA Query Tool without the need for an NDA user account. To request access to record-level human subject data, you must submit a Data Access Request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hongying Daisy Dai', 'investigatorAffiliation': 'University of Nebraska'}}}}