Implementation SciencePhP-VXNCT07207850
Parents Helping Parents for Youth Vaping Cessation
A study testing Parents Helping Parents program in people with Implementation Science and Engagement, Patient, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Implementation Science, Engagement, Patient, E Cigarette Use
- What is being tested?
- Parents Helping Parents program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198-4375
Daisy Dai, PhD, 4025595907, daisy.dai@unmc.edu
About this study
Official title: Parents Helping Parents for Youth Vaping Cessation (PhP-VX)
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.
Read the 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.
- Conditions
- Implementation Science, Engagement, Patient, E Cigarette Use, Peer Support, Vaping Teens, Vaping Cessation
- Being tested
- Parents Helping Parents program
- Keywords
- Vaping, Tobacco, vaping cessation, Parent support, adolescent vaping
- Medical subject headings
- Patient Participation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents Helping Parents programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants in this arm will not receive the PhP-VX treatment. |
| Test Group - PHP-VX Program | Experimental | Participants in this arm will receive the PhP-VX program. Receives: Behavioral: Parents Helping Parents program |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence
Measured: Baseline and Follow ups (1 month, 3 months, 6 months)
Secondary outcomes (3)
Vaping frequency
Measured: 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?".
Measured: Baseline and Follow ups (1 month, 3 months, 6 months)
Other tobacco use
Measured: Baseline and Follow ups (1 month, 3 months, 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start18 May 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implementation ScienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongying Daisy Dai, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207850
- Sponsor's protocol ID
- 0617-25-EP
- Other IDs
- 1R34CA287719-01A1
- Acronym
- PhP-VX
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 42537925
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents Helping Parents for Youth Vaping Cessation (PhP-VX)
- ClinicalTrials.gov ID
- NCT07207850
- Acronym / sponsor ID
- PhP-VX / 0617-25-EP
- Conditions
- Implementation Science, Engagement, Patient, E Cigarette Use, Peer Support, Vaping Teens, Vaping Cessation
- Keywords
- Vaping, Tobacco, vaping cessation, Parent support, adolescent vaping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Cancer Institute (NCI)
- Study start
- 18 May 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants in this arm will not receive the PhP-VX treatment. |
| Test Group - PHP-VX Program | Experimental | Behavioral: Parents Helping Parents programParticipants in this arm will receive the PhP-VX program. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parents Helping Parents programOur 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. | Behavioural | Test Group - PHP-VX Program |
Primary outcome
7-day point prevalence abstinence
Time frame: Baseline and Follow ups (1 month, 3 months, 6 months)
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Derived from this study: PubMed 42537925Michaud 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents Helping Parents program in people with Implementation Science and Engagement, Patient, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daisy Dai, PhD (402-559-5907, daisy.dai@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence (time frame: Baseline and Follow ups (1 month, 3 months, 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07207850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.