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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04707911
Other study ID # T31IR1910
Secondary ID 21633NCI-2021-11
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 18, 2021
Est. completion date July 31, 2024

Study information

Verified date June 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Social media based intervention to support teens in their efforts to quit vaping.


Description:

This study is a randomized controlled trial of a social media intervention to support teens in their efforts to quit vaping.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 21 Years
Eligibility Inclusion Criteria: 1. English literacy 2. Age between 13-21 years 3. Indicate they use social media "most" (>= 4) days per week 4. Have vaped at least once per week in the past 30 days (90 percent of participants) 5. Access to a computer or mobile phone with photo capability to verify abstinence from vaping 6. Indicate they are considering quitting or are interested in quitting with the next 6 months or within the next 30 days 7. Currently reside in California Exclusion Criteria: 1. No English literacy 2. Age under 13 or over 21 3. Insufficient social media use (3 or fewer days per week) 4. Have not vaped at least once per week in past 30 days 5. No access to computer or mobile phone with photo capability to verify abstinence from vaping 6. Not considering or interested in quitting vaping in the next 30 days or 6 months; 7. Not a California resident

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Social Media Intervention
Social media based intervention using Instagram with up to 3 posts per day for 30 days

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (4)

Lead Sponsor Collaborator
University of California, San Francisco HopeLab Foundation, Rescue Agency, Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Point Prevalent Abstinence (PPA) from vaping 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. 1 month
Primary Point Prevalent Abstinence (PPA) from vaping 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
Primary Point Prevalent Abstinence (PPA) from vaping 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. 6 months
Secondary Change in the number of participants with reduction in vaping Reduction in vaping is defined as a decline in vaping frequency by 50 percent (%) or more. Up to 6 months
Secondary Change in the number of vape quit attempts The number of quit attempts will be recorded at each assessment. Up to 6 months
Secondary Number of participants with at least 1 quit attempt The number of participants whom achieved at least one quit attempt during the full assessment time period will be reported. Up to 6 months
Secondary Change in response on Stages of Change Questionnaire 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'. Up to 6 months
Secondary Change in the score on the Thoughts About Abstinence (TAA) Questionnaire 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) Up to 6 months
Secondary Change in the scores on the Ways of Quitting questionnaire (WOQ) 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). Up to 6 months
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