Georgia Health Sciences University
Augusta, Georgia, 30912, United States
NCT Number: NCT01164306
The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:
1. preventing tobacco initiation in youth 2. promoting anti-tobacco socialization in the home 3. decreasing environmental tobacco smoke exposure in children 4. 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.
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Notify Me8 year and older
All sexes
Interventional
Not applicable
Augusta, Georgia, 30912, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: LifeSkills Training (Botvin's)
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 names: Healthy lifestyle behaviors
For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.
Other names: NRT is Nicotine Replacement Therapy, MI is Motivational Interviewing
Time frame: Baseline
Self-report and salivary cotinine is assessed to measure this outcome
Time frame: Year 2
Self-report and salivary cotinine is assessed to measure this outcome.
Time frame: Year 4
Self-report and salivary cotinine is assessed to measure this outcome.
Time frame: 3 months
Time frame: 6 months
Time frame: Year 1
Time frame: Year 2
Time frame: Year 4
Augusta University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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