Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2026-04-30
2026-11-01
Brief Summary
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Detailed Description
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The 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.
Eligible 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.
All 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).
The 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.
Parents 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Participants in this arm will not receive the PhP-VX treatment.
No interventions assigned to this group
Test Group - PHP-VX Program
Participants in this arm will receive the PhP-VX program.
Parents Helping Parents program
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.
Interventions
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Parents Helping Parents program
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.
Eligibility Criteria
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Inclusion Criteria
* Report vaping in the previous 30 days
* English literacy
PARENT INCLUSION:
* Biological, adoptive, stepparents, or adult guardian of adolescent participating
* Have face-to-face contact with the adolescent at least one day per week during the study period
* Access to a computer or mobile phone at home
* Interested in helping adolescent quit e-cigarette/vape use
15 Years
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
National Cancer Institute (NCI)
NIH
University of Nebraska
OTHER
Responsible Party
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Hongying Daisy Dai
Principal Investigator
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0617-25-EP
Identifier Type: -
Identifier Source: org_study_id
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