SmokingNCT02021175
Korean Youth Smoking Cessation Study
A study testing Tailored CBME Therapy via Technology in people with Smoking, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Cigarette smoking remains the leading preventable cause of morbidity and mortality in the United States. In Los Angeles, rates of morbidities due to cigarette smoking follow prevalence. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Smoking
- What is being tested?
- Tailored CBME Therapy via Technology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2018to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Self-identify as Korean or Korean-American
- Smoke at least 5 cigarettes per day for the past 6 months
- Interested in smoking cessation
- Aged between 14-19 years
- Willing to provide information that can assist in locating the individual for follow up visits
- Living in Los Angeles County
Show all 11Show fewer
- Has a phone capable of receiving Short Message Service (SMS) text messages
- Has a computer or other regular access to engage program components
- Willing and able to provide consent if older than 18
- Willing and able to provide assent if under 18 and has a parent or legal guardian willing and able to provide consent
- At least 6th grade English reading level due to requirements of assessment procedures
Who cannot join
- Knowingly moving from the Los Angeles County area in the next year
- Absence of cotinine in urine during the baseline screen
- Concurrent dependence on substance other than nicotine
- History of suicidality in the past year
- Any other circumstances that, in the opinion of the investigators, would compromise participant safety
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90024
About this study
Official title: Adaptation and Development of a Web and Cell Phone Quit Smoking Treatment for Korean Youth
Cigarette smoking remains the leading preventable cause of morbidity and mortality in the United States. In Los Angeles, rates of morbidities due to cigarette smoking follow prevalence. While the rate of cigarette smoking in Los Angeles County among youth is at historic lows, prevalence is not uniform: Cigarette smoking is pervasive among residents who have significant economic disparities. Prevalence is also among the highest in the world for Korean school-aged youth and substantially higher numbers of Korean American youth smoke cigarettes. To date, smoking prevention efforts in Korea have had mixed results as they are not interesting to youth and are not interactive.
This project will assess an interactive, culturally adapted, tailored smoking cessation intervention delivered through the internet and cell phone. Using technology, the investigators seek to increase the reach and access of our intervention and facilitate cessation without in-person sessions, a factor that limits smoking cessation interventions for youth. Youth are energetic users of electronic media, lending support to the delivery of treatment through technology.
The investigators predict that subjects assigned to the intervention will demonstrate statistically higher rates of smoking abstinence and longer retention in the cessation program compared to those assigned to the standard of care condition. Subjects reporting higher levels of smoking exposure, lower motivation, poor mental health, disadvantaged neighborhoods, and lower levels of acculturation to American culture will also have lower quit rates at each follow-up visit.
Read the detailed description
Cigarette smoking remains the leading preventable cause of morbidity and mortality in the United States. While 19% of U.S. twelfth graders smoked cigarettes in the past 30 days, fewer than 10% of Californians under age 18 reported recent smoking. In Los Angeles, rates of morbidities due to cigarette smoking follow prevalence. While the rate of cigarette smoking in Los Angeles County among youth is at historic lows (10.4%), prevalence is not uniform: Cigarette smoking is pervasive among residents who have significant economic disparities. Alarming racial and ethnic disparities are noted with highest prevalence reported for adult Korean males (44.8%). Prevalence of cigarette smoking is also among the highest in the world for Korean school-aged youth, with 16.2% for males and 5.3% for females. To date, smoking prevention efforts in Korea have had mixed results as they are not interesting to youth and are not interactive.
This project will assess an interactive, culturally adapted, tailored smoking cessation intervention delivered through the internet and cell phone. The evidence-based treatment, "Cognitive-Behavioral/Motivational Enhancement Therapy for Smoking Cessation" (CBME) for adolescent smokers was developed by one of the investigators. Based on input from our community partners, consultants, and youth focus group participants, the treatment will be culturally adapted for appropriateness and relevance to Korean youth. The refined intervention will be programmed for delivery via the Web and mobile technologies. Using technology, we seek to increase the reach and access of our intervention and facilitate cessation without in-person sessions, a factor that limits smoking cessation interventions for youth. A 2-group, randomized control trial design will assign youth either to the tailored Web and cell phone based smoking cessation program or to a control condition.
The specific aim of the study is as follows:
- To evaluate the efficacy of the tailored smoking cessation approach for Korean youth seeking smoking cessation, randomly assigning 240 youth to either the experimental condition or to a standard cessation approach.
- Conditions
- Smoking
- Being tested
- Tailored CBME Therapy via Technology, Standard of Care
- Keywords
- Smoking Cessation, Korean, Youth, Adolescent, Dependence, Teen Smoking, Smoking and Youth, Youth and Tobacco, Cognitive-Behavioral Motivational Enhancement, Technology, Nicotine Dependence, Cell Phone, Smart Phone, Internet, Web
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored CBME Therapy via TechnologyBehavioural
6 Sessions of tailored interactive Cognitive-Behavioral Motivational Enhancement Therapy delivered through internet and cell phones
Standard of CareOther
Referral to currently available resources for 6 sessions of a standard smoking cessation approach
| Study group | Role | What they receive |
|---|---|---|
| Tailored CBME Therapy via Technology | Experimental | 6 weeks of tailored interactive Cognitive-Behavioral Motivational Enhancement Therapy delivered through internet and cell phones Receives: Behavioral: Tailored CBME Therapy via Technology |
| Standard of Care | Other | Referral to currently available resources for 6 weeks of a standard smoking cessation approach Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in 7-day point prevalence of smoking abstinence at the end of treatment and at 6-month follow-up evaluations.
At each follow up visit, 7-day point prevalence of smoking abstinence verified by urinary cotinine and carbon monoxide (CO) will be assessed. Variables that mediate outcomes include measures of demographics, withdrawal symptoms, psychiatric and substance use status, impulsivity, health-related quality of life, and neighborhood status and acculturation.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJun 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Unable to build the app for the clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Steve Shoptaw, University of California, Los Angeles
- Investigators
- Steve Shoptaw, Ph.D, Principal investigator, University of California Los Angeles, Center for Behavioral and Addiction MedicineVickie Mays, Ph.D, Principal investigator, University of California Los Angeles, Center for Bridging Research, Innovation, Training, and Education on Minority Disparities Solutions (BRITE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021175
- Sponsor's protocol ID
- P60MD006923
- Other IDs
- P60MD006923
- Status last verified
- Mar 2020
- First submitted
- 6 Feb 2013
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Development of a Web and Cell Phone Quit Smoking Treatment for Korean Youth
- ClinicalTrials.gov ID
- NCT02021175
- Acronym / sponsor ID
- P60MD006923
- Conditions
- Smoking
- Keywords
- Smoking Cessation, Korean, Youth, Adolescent, Dependence, Teen Smoking, Smoking and Youth, Youth and Tobacco
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to build the app for the clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 27 Dec 2013 (estimated)
- 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.
Cigarette smoking remains the leading preventable cause of morbidity and mortality in the United States. In Los Angeles, rates of morbidities due to cigarette smoking follow prevalence. While the rate of cigarette smoking in Los Angeles County among youth is at historic lows, prevalence is not uniform: Cigarette smoking is pervasive among residents who have significant economic disparities. Prevalence is also among the highest in the world for Korean school-aged youth and substantially higher numbers of Korean American youth smoke cigarettes. To date, smoking prevention efforts in Korea have had mixed results as they are not interesting to youth and are not interactive.
This project will assess an interactive, culturally adapted, tailored smoking cessation intervention delivered through the internet and cell phone. Using technology, the investigators seek to increase the reach and access of our intervention and facilitate cessation without in-person sessions, a factor that limits smoking cessation interventions for youth. Youth are energetic users of electronic media, lending support to the delivery of treatment through technology.
The investigators predict that subjects assigned to the intervention will demonstrate statistically higher rates of smoking abstinence and longer retention in the cessation program compared to those assigned to the standard of care condition. Subjects reporting higher levels of smoking exposure, lower motivation, poor mental health, disadvantaged neighborhoods, and lower levels of acculturation to American culture will also have lower quit rates at each follow-up visit.
Detailed description
Cigarette smoking remains the leading preventable cause of morbidity and mortality in the United States. While 19% of U.S. twelfth graders smoked cigarettes in the past 30 days, fewer than 10% of Californians under age 18 reported recent smoking. In Los Angeles, rates of morbidities due to cigarette smoking follow prevalence. While the rate of cigarette smoking in Los Angeles County among youth is at historic lows (10.4%), prevalence is not uniform: Cigarette smoking is pervasive among residents who have significant economic disparities. Alarming racial and ethnic disparities are noted with highest prevalence reported for adult Korean males (44.8%). Prevalence of cigarette smoking is also among the highest in the world for Korean school-aged youth, with 16.2% for males and 5.3% for females. To date, smoking prevention efforts in Korea have had mixed results as they are not interesting to youth and are not interactive.
This project will assess an interactive, culturally adapted, tailored smoking cessation intervention delivered through the internet and cell phone. The evidence-based treatment, "Cognitive-Behavioral/Motivational Enhancement Therapy for Smoking Cessation" (CBME) for adolescent smokers was developed by one of the investigators. Based on input from our community partners, consultants, and youth focus group participants, the treatment will be culturally adapted for appropriateness and relevance to Korean youth. The refined intervention will be programmed for delivery via the Web and mobile technologies. Using technology, we seek to increase the reach and access of our intervention and facilitate cessation without in-person sessions, a factor that limits smoking cessation interventions for youth. A 2-group, randomized control trial design will assign youth either to the tailored Web and cell phone based smoking cessation program or to a control condition.
The specific aim of the study is as follows:
- To evaluate the efficacy of the tailored smoking cessation approach for Korean youth seeking smoking cessation, randomly assigning 240 youth to either the experimental condition or to a standard cessation approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored CBME Therapy via Technology | Experimental | Behavioral: Tailored CBME Therapy via Technology6 weeks of tailored interactive Cognitive-Behavioral Motivational Enhancement Therapy delivered through internet and cell phones |
| Standard of Care | Other | Other: Standard of CareReferral to currently available resources for 6 weeks of a standard smoking cessation approach |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Self-identify as Korean or Korean-American
- Smoke at least 5 cigarettes per day for the past 6 months
- Interested in smoking cessation
- Aged between 14-19 years
- Willing to provide information that can assist in locating the individual for follow up visits
Key exclusion criteria (5 listed)
- Knowingly moving from the Los Angeles County area in the next year
- Absence of cotinine in urine during the baseline screen
- Concurrent dependence on substance other than nicotine
- History of suicidality in the past year
- Any other circumstances that, in the opinion of the investigators, would compromise participant safety
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 |
|---|---|---|
| Tailored CBME Therapy via Technology6 Sessions of tailored interactive Cognitive-Behavioral Motivational Enhancement Therapy delivered through internet and cell phones | Behavioural | Tailored CBME Therapy via Technology |
| Standard of CareReferral to currently available resources for 6 sessions of a standard smoking cessation approach | Other | Standard of Care |
Primary outcome
Reduction in 7-day point prevalence of smoking abstinence at the end of treatment and at 6-month follow-up evaluations.
Time frame: 18 weeks
At each follow up visit, 7-day point prevalence of smoking abstinence verified by urinary cotinine and carbon monoxide (CO) will be assessed. Variables that mediate outcomes include measures of demographics, withdrawal symptoms, psychiatric and substance use status, impulsivity, health-related quality of life, and neighborhood status and acculturation.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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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. This study is not recruiting at the moment.
Steve Shoptaw, Ph.D principal investigator
University of California Los Angeles, Center for Behavioral and Addiction Medicine
Vickie Mays, Ph.D principal investigator
University of California Los Angeles, Center for Bridging Research, Innovation, Training, and Education on Minority Disparities Solutions (BRITE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored CBME Therapy via Technology in people with Smoking, run by University of California, Los Angeles 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?
The sponsor lists 11 inclusion and 5 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 25 Mar 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in 7-day point prevalence of smoking abstinence at the end of treatment and at 6-month follow-up evaluations. (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2020.