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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RECRUITING
PHASE2
306 participants
INTERVENTIONAL
2025-01-16
2029-08-31
Brief Summary
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Abstinence rates will be assessed biweekly during treatment including at end of treatment (EOT), and then at 1, 2, 3 and 6 month follow ups (FU). Biochemical verification (salivary cotinine \< 30 ng.ml) of self-reports of abstinence will be conducted at EOT and 6-month FU.
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Detailed Description
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Description of NCI Quit Vaping webpage: The NCI webpage provides quitting tobacco resources for youth, including for e-cigarettes. Importantly, the information provided is similar to the CBT (Cognitive Behavioral Therapy) skills modeled by the Kick-Nic! © app. The Quit Vaping section provides education/modules on how to quit vaping including 1) "build my quit plan", 2) "get a vaping reality check", 3) "how to quit vaping", 4) "your first day without vaping", 5) "deal with vape cravings", 6) "understand your vape triggers", 7) "vaping addiction and nicotine withdrawal", 8) "anxiety, stress and vaping", and 9) "depression and vaping". Adolescents have the option of speaking to an NCI LiveHelp specialist, and access to a Quitline number (800-QUIT-NOW) which can provide further access to counselors.
ACTIVE group participants will be introduced to the app. They will receive instructions on logging in, navigation and will receive a FAQ sheet (via text or email) that will detail this information. They will receive standard advice to avoid use of other tobacco products, cannabis, or e-cigarettes without nicotine. Participants will be asked to use the app over an 8-week period, complete one module each week, and practice the skills that they learned between modules. They will be told that the app will help them set a quit day and that they should complete the first two modules which would teach them how to prepare for quitting before their quit day.
Engagement will be encouraged using text/motivational messages and weekly personal check-ins. Additionally, participants will also receive weekly personal check-ins during the 8-week treatment period which will be conducted by research staff and will use voice or video calls (preferably) or text (depending on the participant's preference) and a standardized script for various scenarios. Staff will check in on whether participants completed the modules. If not, they will provide support to address any barriers to completing the modules, motivational messages to encourage module completion and to practice skills they will learn. If participants have completed the module that was due to be completed that week, they will receive motivational messages to encourage them to practice the skills they learned. The check-ins will not provide any further quit advice (to avoid interfering with the content of the app).
Assessments will be obtained at baseline (week 0; treatment initiation), every two weeks (weeks 2, 4, 6, 8) during the treatment period, and then at 1, 2, 3 and then 6 months follow up timepoints by research assistants who will be blind to the randomization condition.
Qualitative interviews will be conducted with up to 50% of participants in the ACTIVE group to assess adolescent perspectives of the app and on how the intervention should be disseminated to maximize reach and engagement of high school youth.
CONTROL group participants will be introduced to the NCI webpage and asked to use those resources during the 8-week period and will be scheduled to complete assessments on the same schedule as the ACTIVE group. They will not complete interviews.
Follow-up visits will be conducted 1, 2, 3, and 6 months after the 8 week treatment period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ACTIVE
Participants in the active group will be given access to the Kick-Nic! app to use for vaping cessation.
Kick-Nic! mobile phone application
The Kick-Nic! app has seven modules that cover core CBT strategies using skills, graphic illustrations, and interactive components to help adolescents quit using e-cigarettes.
CONTROL
Participants in the control group will be referred to the NCI Quit Vaping website.
NCI Quit Vaping website
The NCI webpage provides quitting tobacco resources for youth, including for e-cigarettes. The information provided is similar to the CBT skills modeled by the Kick-Nic! app.
Interventions
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Kick-Nic! mobile phone application
The Kick-Nic! app has seven modules that cover core CBT strategies using skills, graphic illustrations, and interactive components to help adolescents quit using e-cigarettes.
NCI Quit Vaping website
The NCI webpage provides quitting tobacco resources for youth, including for e-cigarettes. The information provided is similar to the CBT skills modeled by the Kick-Nic! app.
Eligibility Criteria
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Inclusion Criteria
2. regular current (past month) e-cig users using nicotine-containing e-cigs at least 1 day/week.
3. want to quit using e-cigarettes.
4. have a smartphone with data/WIFI plan in order to access and utilize the KickNic! app
Exclusion Criteria
13 Years
19 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Suchitra Krishnan-Sarin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University School of Medicine, Dept of Psychiatry
Locations
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Yale University School of Medicine (Connecticut Mental Health Center)
New Haven, Connecticut, 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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2000035028
Identifier Type: -
Identifier Source: org_study_id
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