Cognitive Behavior Therapy Clinical Trial
Official title:
Motivation and Skills for Detained Teen Smokers
NCT number | NCT01387516 |
Other study ID # | R01DA020731 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2007 |
Est. completion date | May 2014 |
Verified date | April 2020 |
Source | University of Rhode Island |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The long-term objective of this research is to increase the investigators understanding of
effective smoking interventions for understudied adolescents at high risk for continued
smoking into adulthood.
This randomized clinical trial uses a 2 x 2 between groups design to investigate Motivational
Interviewing (MI) versus Relaxation Therapy (RT), and Cognitive Behavior Therapy (CBT) versus
Self-Help Programming (SHP). Treatments are provided during brief stay in detention and
adolescents are followed after release. The investigators seek to increase quit rates
post-release, and the investigators will examine the moderating and mediating effects of
motivation, anger, and self-efficacy. The investigators will study main effects for treatment
as well as whether the combination of MI/CBT is more effective than other treatments in
enhancing quit rates.
Frequently, treatment for smoking cessation is unavailable to youths in the juvenile justice
system, and when treatment is available, it may be provided using untested therapies. This
study extends previous research by rigorously evaluating smoking cessation interventions
specifically for teens at highest risk for continued smoking in adulthood. The investigators
will examine processes contributing to the efficacy of treatments. The development of
effective smoking interventions for juvenile detainees has the potential to reduce a
significant public health concern in this undeserved and high-risk population.
Status | Completed |
Enrollment | 314 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 19 Years |
Eligibility |
Inclusion Criteria: - 13-19 years old, - smokes average of 1 cigarette or cigarillo per day - in facility for at least 4 days. Exclusion Criteria: - non-smoker, - not in facility long enough (i.e. 4 days). |
Country | Name | City | State |
---|---|---|---|
United States | Rhode Island Training School | Cranston | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
University of Rhode Island |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cigarette Use, Average # of Cigarettes Per Smoking Day. | Using a 60-day TLFB we collected the average number of cigarettes smoked per smoking day at 6-month follow-ups | 6 months post release | |
Primary | Number of Subjects Who Were Verified Abstinent From Smoking Using CO Levels and Cotinine in the Saliva | A smokelyzer and a saliva sample are used to get information on CO levels and cotinine in the saliva as biochemical markers for our research. These levels will determine if the participant is verified as being abstinent from smoking during the week before collection. Biochemical markers are collected at Baseline, 3 and 6 month follow up assessments. | 6 months post release | |
Primary | American Thoracic Society Questionnaire (ATSQ) | This validated 8 item measure assesses the frequency of experiencing several respiratory symptoms using a 5 point Likert scale from 1, never to 5, every day. The minimum score is 8 indicating no experience of respiratory symptoms and the maximum score is 40 which indicates a high frequency of experiencing respiratory symptoms. | 6 months post release | |
Primary | Percent Smoking Days | Using a Time-Line Follow-back, we calculated percent smoking days for a 60 day period at 6-month follow-up. This is the percentage of smoking days a participant had out of possible smoking days (days for which the participant was not in a controlled environment where they did not have access to cigarettes). | 6 months post release |
Status | Clinical Trial | Phase | |
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