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Parents Helping Parents for Youth Vaping Cessation

Parents Helping Parents for Youth Vaping Cessation (PhP-VX)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07207850
Acronym
PhP-VX
Enrollment
200
Registered
2025-10-06
Start date
2026-05-18
Completion date
2027-08-31
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E Cigarette Use, Engagement, Patient, Implementation Science, Parent Support, Peer Support, Vaping Cessation, Vaping Teens

Keywords

Vaping, Tobacco, vaping cessation, Parent support, adolescent vaping

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALParents 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.

Sponsors

University of Nebraska
Lead SponsorOTHER
Massachusetts General Hospital
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

ADOLESCENT INCLUSION: * 15-18 * 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

Design outcomes

Primary

MeasureTime frame
7-day point prevalence abstinenceBaseline and Follow ups (1 month, 3 months, 6 months)

Secondary

MeasureTime frameDescription
Vaping frequencyBaseline and Follow ups (1 month, 3 months, 6 months)
Past 7 day Vaping intensityBaseline and Follow ups (1 month, 3 months, 6 months)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?".
Other tobacco useBaseline and Follow ups (1 month, 3 months, 6 months)

Countries

United States

Contacts

CONTACTDaisy Dai, PhD
daisy.dai@unmc.edu402-559-5907

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026