An interventional study of Parents Helping Parents program in Implementation Science, Engagement, Patient and E Cigarette Use, sponsored by University of Nebraska. Recruiting at 1 site in United States. Open to participants aged 15 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University of Nebraska · Not applicable, Interventional, and Prevention
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.
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.
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 at the completion of the study.
402 studies on the registry are indexed under Vaping; 95 are open to participants now.
This study's planned enrollment of 200 is above the median of 79 across 322 interventional studies indexed under Vaping.
Browse Vaping studies →University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
Compared within Vaping, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Patient Participation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
ADOLESCENT INCLUSION:
PARENT INCLUSION:
Participants in this arm will not receive the PhP-VX treatment.
Participants in this arm will receive the PhP-VX program.
Behavioral: 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 at the end of the study.
7-day point prevalence abstinence
Time frame: Baseline and Follow ups (1 month, 3 months, 6 months)
Vaping frequency
Time frame: Baseline and Follow ups (1 month, 3 months, 6 months)
Past 7 day Vaping intensity
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?".
Time frame: Baseline and Follow ups (1 month, 3 months, 6 months)
Other tobacco use
Time frame: Baseline and Follow ups (1 month, 3 months, 6 months)
Plan to share: Yes — 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.
Supporting information: Statistical analysis plan
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · nda.nih.gov
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