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

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Augusta University

Status

Completed

Conditions

Environmental Tobacco Smoke Exposure
Tobacco Prevention
Tobacco Cessation

Treatments

Behavioral: NRT and Motivational Interviewing (MI)
Behavioral: Healthy Lifestyle Behavior Choices
Behavioral: LifeSkills Training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01164306
R01CA118066 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment

688 patients

Sex

All

Ages

8+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

688 participants in 2 patient groups

LifeSkills training
Experimental group
Treatment:
Behavioral: LifeSkills Training
Behavioral: NRT and Motivational Interviewing (MI)
Healthy Lifestyle Behaviors
Active Comparator group
Treatment:
Behavioral: Healthy Lifestyle Behavior Choices

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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