Parents Helping Parents for Youth Vaping Cessation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parents Helping Parents program.
- Who it may be relevant to
- Registry conditions: Implementation Science, Engagement, Patient, E Cigarette Use, Peer Support. Basic parameters: 15 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Parents Helping Parents for Youth Vaping Cessation (PhP-VX)
Overview
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
- 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.
Primary outcome measures
- 7-day point prevalence abstinence [Time frame: Baseline and Follow ups (1 month, 3 months, 6 months)]
Secondary outcome measures (3)
- Vaping frequency [Time frame: Baseline and Follow ups (1 month, 3 months, 6 months)]
- Past 7 day Vaping intensity [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)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Nebraska Medical Center — Omaha
Publications
- Michaud TL, Reyes S, Guenzel N, Guastello P, Kerns E, Berkman M, Fuhrman D, Skrobola L, Joyce C, Nabi E, Winickoff JP, Dai HD. Remotely delivered parents helping parents for youth nicotine vaping cessation recruited via electronic health records: Protocol for a feasibility randomized controlled trial. Contemp Clin Trials. 2026 Jul 31:108416. doi: 10.1016/j.cct.2026.108416. Online ahead of print. PMID 42537925
Identifiers
NCT: NCT07207850 · 0617-25-EP · 1R34CA287719-01A1