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The Impact of a Tobacco Control Intervention in African-American Families

The Impact of a Tobacco Control Intervention in African-American Families

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01164306
Enrollment
688
Registered
2010-07-16
Start date
2007-09-30
Completion date
2014-05-31
Last updated
2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Environmental Tobacco Smoke Exposure, Tobacco Cessation, Tobacco Prevention

Keywords

LifeSkills Training, Tobacco prevention, Tobacco cessation, Healthy lifestyles, Tobacco control

Brief summary

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.

Detailed 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).

Interventions

BEHAVIORALLifeSkills 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.

BEHAVIORALHealthy 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.

BEHAVIORALNRT and Motivational Interviewing (MI)

For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Primary prevention of tobacco use in youthBaselineSelf-report and salivary cotinine is assessed to measure this outcome

Secondary

MeasureTime frame
Smoking cessation in parents/guardians3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026