Clinical trial NCT01164306: The Impact of a Tobacco Control Intervention in African-American Families
Official title: The Impact of a Tobacco Control Intervention in African-American Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Prevention
Environmental Tobacco Smoke Exposure
Tobacco Cessation
Keywords: LifeSkills Training
Tobacco prevention
Tobacco cessation
Healthy lifestyles
Tobacco control
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-07-16
Enrollment: 688
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Primary prevention of tobacco use in youth
timeFrame: Baseline
measure: Primary prevention of tobacco use in youth
timeFrame: Year 2
measure: Primary prevention of tobacco use in youth
timeFrame: Year 4
Secondary outcomes:
measure: Smoking cessation in parents/guardians
timeFrame: 3 months
measure: Smoking cessation in parents/guardians
timeFrame: 6 months
measure: Smoking cessation in parents/guardians
timeFrame: Year 1
measure: Smoking cessation in parents/guardians
timeFrame: Year 2
measure: Smoking cessation in parents/guardians
timeFrame: Year 4
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
Study officials:
affiliation: Augusta University
name: Martha S Tingen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caldwell AL, Tingen MS, Nguyen JT, Andrews JO, Heath J, Waller JL, Treiber FA. Parental Smoking Cessation: Impacting Children's Tobacco Smoke Exposure in the Home. Pediatrics. 2018 Jan;141(Suppl 1):S96-S106. doi: 10.1542/peds.2017-1026M.