Korean Youth Smoking Cessation Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of California, Los Angeles
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Steve Shoptaw, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02021175
First received: February 6, 2013
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Smoking
Behavioral: Tailored CBME Therapy via Technology
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adaptation and Development of a Web and Cell Phone Quit Smoking Treatment for Korean Youth

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 240
Study Start Date: September 2014
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tailored CBME Therapy via Technology
6 weeks of tailored interactive Cognitive-Behavioral Motivational Enhancement Therapy delivered through internet and cell phones
Behavioral: Tailored CBME Therapy via Technology
6 Sessions of tailored interactive Cognitive-Behavioral Motivational Enhancement Therapy delivered through internet and cell phones
Standard of Care
Referral to currently available resources for 6 weeks of a standard smoking cessation approach
Other: Standard of Care
Referral to currently available resources for 6 sessions of a standard smoking cessation approach

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:

1. 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.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021175

Contacts
Contact: Steve Shoptaw, Ph.D (310) 794-0619 ext 225 sshoptaw@mednet.ucla.edu

Locations
United States, California
University of California, Los Angeles Not yet recruiting
Los Angeles, California, United States, 90024
Contact: Steve Shoptaw, Ph.D    310-794-0619 ext 225    sshoptaw@mednet.ucla.edu   
Principal Investigator: Steve Shoptaw, Ph.D         
Principal Investigator: Vickie Mays, Ph.D         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Steve Shoptaw, Ph.D University of California Los Angeles, Center for Behavioral and Addiction Medicine
Principal Investigator: Vickie Mays, Ph.D University of California Los Angeles, Center for Bridging Research, Innovation, Training, and Education on Minority Disparities Solutions (BRITE)
  More Information

No publications provided

Responsible Party: Steve Shoptaw, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02021175     History of Changes
Other Study ID Numbers: P60 MD006923, P60MD006923
Study First Received: February 6, 2013
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Smoking Cessation
Teen Smoking
Smoking and Youth
Korean
Youth
Adolescent
Dependence
Youth and Tobacco
Cognitive-Behavioral Motivational Enhancement
Technology
Nicotine Dependence
Cell Phone
Smart Phone
Internet
Web

ClinicalTrials.gov processed this record on October 01, 2014