This trial is active, not recruiting.

Conditions tobacco prevention, environmental tobacco smoke exposure, tobacco cessation
Treatments lifeskills training, healthy lifestyle behavior choices, nrt and motivational interviewing (mi)
Sponsor Georgia Regents University
Collaborator National Cancer Institute (NCI)
Start date September 2007
End date May 2013
Trial size 688 participants
Trial identifier NCT01164306, R01CA118066


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
lifeskills training LifeSkills Training (Botvin's)
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.
nrt and motivational interviewing (mi) NRT is Nicotine Replacement Therapy
For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.
(Active Comparator)
healthy lifestyle behavior choices Healthy lifestyle behaviors
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.

Primary Outcomes

Primary prevention of tobacco use in youth
time frame: Baseline
Primary prevention of tobacco use in youth
time frame: Year 2
Primary prevention of tobacco use in youth
time frame: Year 4

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 8 years old.

Inclusion Criteria: - child being of African-American ethnicity - in a 4th grade classroom of randomized schools - parent or guardian that 4th grade child resides with at least 50% of the time - have access to a telephone or mobile phone Exclusion Criteria: - not being a child of African-American ethnicity - not being a parent or guardian that an eligible child lives with at least 50% of the time - not having access to a telephone or cell phone

Additional Information

Official title The Impact of a Tobacco Control Intervention in African-American Families
Principal investigator Martha S Tingen, PhD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Georgia Regents University.