- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04707911
Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
June 1, 2023 updated by: University of California, San Francisco
Social media based intervention to support teens in their efforts to quit vaping.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial of a social media intervention to support teens in their efforts to quit vaping.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sarah Rosen, BA
- Phone Number: 415-502-0758
- Email: quitthehit@ucsf.edu
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- English literacy
- Age between 13-21 years
- Indicate they use social media "most" (>= 4) days per week
- Have vaped at least once per week in the past 30 days (90 percent of participants)
- Access to a computer or mobile phone with photo capability to verify abstinence from vaping
- Indicate they are considering quitting or are interested in quitting with the next 6 months or within the next 30 days
- Currently reside in California
Exclusion Criteria:
- No English literacy
- Age under 13 or over 21
- Insufficient social media use (3 or fewer days per week)
- Have not vaped at least once per week in past 30 days
- No access to computer or mobile phone with photo capability to verify abstinence from vaping
- Not considering or interested in quitting vaping in the next 30 days or 6 months;
- Not a California resident
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vaping Intervention
The vaping intervention will be implemented on Instagram.
Participants in the treatment condition will be assigned to groups on Instagram, where they will receive up to 3 posts per day for 30 days.
Groups are facilitated by a trained Guide, working with the Principal Investigator, Co-Investigators and a Pediatrician on demand if additional expertise or clinical advice is needed.
Participants will be educated about signs of nicotine dependence and if they express interest in pharmacotherapy will be encouraged to access this through their personal healthcare providers.
The Instagram groups will provide educational and social support, troubleshooting and advice about nicotine replacement therapy (NRT) or other forms of treatment.
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Social media based intervention using Instagram with up to 3 posts per day for 30 days
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No Intervention: Control Condition
Participants in the control condition will be directed to the Truth Initiative e-cigarette texting quit program.
This innovative and free text message program was created with input from teens, college students and young adults who have attempted to, or successfully, quit e-cigarettes using text coaching methods
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point Prevalent Abstinence (PPA) from vaping
Time Frame: 1 month
|
7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study.
Participants reporting no vaping in the past 7 days will be coded as abstinent.
Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.
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1 month
|
Point Prevalent Abstinence (PPA) from vaping
Time Frame: 3 months
|
7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study.
Participants reporting no vaping in the past 7 days will be coded as abstinent.
Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.
|
3 months
|
Point Prevalent Abstinence (PPA) from vaping
Time Frame: 6 months
|
7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study.
Participants reporting no vaping in the past 7 days will be coded as abstinent.
Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the number of participants with reduction in vaping
Time Frame: Up to 6 months
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Reduction in vaping is defined as a decline in vaping frequency by 50 percent (%) or more.
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Up to 6 months
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Change in the number of vape quit attempts
Time Frame: Up to 6 months
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The number of quit attempts will be recorded at each assessment.
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Up to 6 months
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Number of participants with at least 1 quit attempt
Time Frame: Up to 6 months
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The number of participants whom achieved at least one quit attempt during the full assessment time period will be reported.
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Up to 6 months
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Change in response on Stages of Change Questionnaire
Time Frame: Up to 6 months
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The participants readiness to quit will be measured using the Stages of Change questionnaire - single item, which asks "Are you seriously thinking of quitting smoking?" Answers range from 'Yes, within the next 30 days', 'Yes, within the next 6 months', and 'No, not thinking of quitting'.
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Up to 6 months
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Change in the score on the Thoughts About Abstinence (TAA) Questionnaire
Time Frame: Up to 6 months
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The adapted Thoughts About Abstinence Questionnaire (Hall et al., 1991) is a 3 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty)
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Up to 6 months
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Change in the scores on the Ways of Quitting questionnaire (WOQ)
Time Frame: Up to 6 months
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The WOQ is a 28-item self-report instrument assessing adolescent smoking cessation strategies.
For each WOQ item, respondents indicate whether they have used a given strategy (yes/no) and, if used, how helpful it was perceived to be on a five-point Likert-type scale (1= "Not helpful" to 5="Extremely helpful") with regard to several categories: Social support, Seeking assistance, Avoidance, Reduction, Substitution, Medication, Distraction, and Quit all at once (single item).
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Up to 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pamela Ling, MD, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2021
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
July 31, 2024
Study Registration Dates
First Submitted
January 11, 2021
First Submitted That Met QC Criteria
January 11, 2021
First Posted (Actual)
January 13, 2021
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
June 1, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T31IR1910
- 21633 (Other Identifier: University of California, San Francisco)
- NCI-2021-11423 (Registry Identifier: NCI Clinical Trials Reporting Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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