NCT02021175

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
4.4 years until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

February 6, 2013

Last Update Submit

March 23, 2020

Conditions

Keywords

Smoking CessationKoreanYouthAdolescentDependenceTeen SmokingSmoking and YouthYouth and TobaccoCognitive-Behavioral Motivational EnhancementTechnologyNicotine DependenceCell PhoneSmart PhoneInternetWeb

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 weeks

Study Arms (2)

Tailored CBME Therapy via Technology

EXPERIMENTAL

6 weeks of tailored interactive Cognitive-Behavioral Motivational Enhancement Therapy delivered through internet and cell phones

Behavioral: Tailored CBME Therapy via Technology

Standard of Care

OTHER

Referral to currently available resources for 6 weeks of a standard smoking cessation approach

Other: Standard of Care

Interventions

6 Sessions of tailored interactive Cognitive-Behavioral Motivational Enhancement Therapy delivered through internet and cell phones

Tailored CBME Therapy via Technology

Referral to currently available resources for 6 sessions of a standard smoking cessation approach

Standard of Care

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

SmokingSmoking CessationTobacco Use Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

BehaviorHealth BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2013

First Posted

December 27, 2013

Study Start

June 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations