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Completed

NCT Number: NCT01164306

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

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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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LifeSkills Training

Behavioral

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)

Healthy Lifestyle Behavior Choices

Behavioral

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

NRT and Motivational Interviewing (MI)

Behavioral

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

Primary outcomes

  1. Primary prevention of tobacco use in youth

    Time frame: Baseline

    Self-report and salivary cotinine is assessed to measure this outcome

  2. Primary prevention of tobacco use in youth

    Time frame: Year 2

    Self-report and salivary cotinine is assessed to measure this outcome.

  3. Primary prevention of tobacco use in youth

    Time frame: Year 4

    Self-report and salivary cotinine is assessed to measure this outcome.

Secondary outcomes

  1. Smoking cessation in parents/guardians

    Time frame: 3 months

  2. Smoking cessation in parents/guardians

    Time frame: 6 months

  3. Smoking cessation in parents/guardians

    Time frame: Year 1

  4. Smoking cessation in parents/guardians

    Time frame: Year 2

  5. Smoking cessation in parents/guardians

    Time frame: Year 4

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2014
First posted
Jul 16, 2010
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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