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| Sponsor: | Nationwide Children's Hospital |
|---|---|
| Collaborator: |
University of Florida |
| Information provided by: | Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01056588 |
Purpose
The primary objective of this research is to evaluate the effectiveness of this type of smoking cessation program by comparing a treatment group with a control group.
A secondary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens participating in a quit-smoking program.
Hypothesis 1. A greater proportion of the participants in the treatment condition will be verified as abstinent from smoking during the course of treatment than participants of the control condition.
Hypothesis 2. It is hypothesized that teens who do not successfully stop smoking (or who drop out of the treatment program) will be more impulsive (from measures taken just prior to treatment) than those who do successfully stop or significantly reduce rate of smoking.
| Condition | Intervention |
|---|---|
|
Cigarette Smoking |
Behavioral: CO-Contingent Behavioral: Control condition |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Predictors of Smoking Outcomes During Treatment Programs |
| Estimated Enrollment: | 126 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control Condition
In this condition, participants will receive reinforcement for timely breath samples with no contingency for a specific breath CO level.
|
Behavioral: Control condition
In this condition, participants will receive monetary reinforcement for timely breath samples with no contingency for a specific breath CO level
|
|
Active Comparator: CO-Contingent
In this condition, participants will receive reinforcements contingent on submitting breath samples at CO levels indicating reductions or abstinence from smoking.
|
Behavioral: CO-Contingent
In this 42 day condition, participants will receive monetary reinforcements contingent on submitting breath samples at CO levels indicating reductions or abstinence from smoking (4ppm).
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In response to the need for treatments appropriate for adolescent smokers, this research (utilizing a two-group randomized-control design, n = 63 per group) will evaluate the effectiveness and efficacy of a new and innovative Internet-based contingency-management (CM) program for smoking abstinence with adolescent smokers. This program lasts for 42 days and involves a 21 day abstinence phase. For the treatment condition, participants are reinforced for breath samples that verify abstinence from smoking three times per day; however, for the control condition, participants are reinforced for timely breath samples regardless of abstinence status.
Because this CM program is Internet based it can be completed from home, which stands to be more viable as a treatment option for adolescent smokers than other treatments requiring frequent trips to a clinical facility. From preliminary work with adult and adolescent smokers, it is expected this treatment program will be highly effective in creating favorable changes in adolescent smoking behavior. This research will also involve eight monthly post-treatment follow-up sessions to determine long-term consistencies or changes in smoking behavior.
A secondary goal of this research is to explore pre-treatment assessments of different dimensions of impulsive behavior as predictors of treatment outcome. These behavioral assessments will provide highly detailed information about the specific behavioral styles of adolescent smokers who are unable to effectively change their smoking behavior during treatment. This information should provide new points of emphasis for treatment-program modifications to improve these programs to be more effective for adolescents most challenged in their efforts to quit or reduce smoking.
Eligibility| Ages Eligible for Study: | 13 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Millie Harris, PhD | 614-722-3021 | millie.harris@nationwidechildrens.org |
| Contact: Ariane Hawkins | 614-355-3555 | ariane.hawkins@nationwidechildrens.org |
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Michele Patak, MSW 614-355-3602 michele.patak@nationwidechildrens.org | |
| Principal Investigator: | Brady Reynolds, PhD | Nationwide Children's Hopsital |
More Information
| Responsible Party: | Brady Reynolds, PhD Prinicipal Investigator, Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01056588 History of Changes |
| Other Study ID Numbers: | IRB09-00399 |
| Study First Received: | January 25, 2010 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
adolescent smoking Contingency management Quit smoking |
|
Smoking Habits |
