The Impact of a Tobacco Control Intervention in African-American Families
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|ClinicalTrials.gov Identifier: NCT01164306|
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : February 2, 2015
The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:
- preventing tobacco initiation in youth
- promoting anti-tobacco socialization in the home
- decreasing environmental tobacco smoke exposure in children
- promoting successful cessation in parent/guardian smokers.
Control arm participants receive general health education. This family-based approach is implemented with school systems as the primary point of entry.
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Prevention Environmental Tobacco Smoke Exposure Tobacco Cessation||Behavioral: LifeSkills Training Behavioral: Healthy Lifestyle Behavior Choices Behavioral: NRT and Motivational Interviewing (MI)||Not Applicable|
All research participants (children and parents/guardians) will be recruited from 14 schools (7 control and 7 intervention; 7 urban and 7 rural) in a Southeastern U.S.
Self-report measures are at: baseline, end of year one, year 2, end of year two, and years three and four. Biological measures of salivary cotinine are at Baseline, end of treatment (year 2) and end of study (year 4).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||688 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of a Tobacco Control Intervention in African-American Families|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2014|
|Experimental: LifeSkills training||
Behavioral: LifeSkills Training
LifeSkills Training (Botvin's) is an evidenced based substance abuse prevention program for elementary school students to learn skills to resist tobacco, alcohol, drug abuse, and violence.
Parent LifeSkills will also be utilized. Parents are provided a parent manual and DVD to use at home with their child to reinforce what they are taught in school-based LifeSkills sessions.
Other Name: LifeSkills Training (Botvin's)
Behavioral: NRT and Motivational Interviewing (MI)
For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.
|Active Comparator: Healthy Lifestyle Behaviors||
Behavioral: Healthy Lifestyle Behavior Choices
The healthy lifestyle behavior choices curriculum augments the state health curriculum in the assigned study schools.
Parents will also be given health related information by mail to parallel the information students receive in school health classes.
Other Name: Healthy lifestyle behaviors
- Primary prevention of tobacco use in youth [ Time Frame: Baseline ]Self-report and salivary cotinine is assessed to measure this outcome
- Primary prevention of tobacco use in youth [ Time Frame: Year 2 ]Self-report and salivary cotinine is assessed to measure this outcome.
- Primary prevention of tobacco use in youth [ Time Frame: Year 4 ]Self-report and salivary cotinine is assessed to measure this outcome.
- Smoking cessation in parents/guardians [ Time Frame: 3 months ]
- Smoking cessation in parents/guardians [ Time Frame: 6 months ]
- Smoking cessation in parents/guardians [ Time Frame: Year 1 ]
- Smoking cessation in parents/guardians [ Time Frame: Year 2 ]
- Smoking cessation in parents/guardians [ Time Frame: Year 4 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164306
|United States, Georgia|
|Georgia Health Sciences University|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Martha S Tingen, PhD||Augusta University|