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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Martha Tingen, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT01164306
First received: May 12, 2010
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Tobacco Prevention
Environmental Tobacco Smoke Exposure
Tobacco Cessation
Behavioral: LifeSkills Training
Behavioral: Healthy Lifestyle Behavior Choices
Behavioral: NRT and Motivational Interviewing (MI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Impact of a Tobacco Control Intervention in African-American Families

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Primary prevention of tobacco use in youth [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Self-report and salivary cotinine is assessed to measure this outcome

  • Primary prevention of tobacco use in youth [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
    Self-report and salivary cotinine is assessed to measure this outcome.

  • Primary prevention of tobacco use in youth [ Time Frame: Year 4 ] [ Designated as safety issue: No ]
    Self-report and salivary cotinine is assessed to measure this outcome.


Secondary Outcome Measures:
  • Smoking cessation in parents/guardians [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Smoking cessation in parents/guardians [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Smoking cessation in parents/guardians [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Smoking cessation in parents/guardians [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
  • Smoking cessation in parents/guardians [ Time Frame: Year 4 ] [ Designated as safety issue: No ]

Enrollment: 688
Study Start Date: September 2007
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LifeSkills training Behavioral: LifeSkills 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.

Other Name: LifeSkills Training (Botvin's)
Behavioral: NRT and Motivational Interviewing (MI)
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
Active Comparator: Healthy Lifestyle Behaviors Behavioral: Healthy 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.

Other Name: Healthy lifestyle behaviors

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

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164306

Locations
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Martha S Tingen, PhD Georgia Regents University
  More Information

No publications provided

Responsible Party: Martha Tingen, Professor, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01164306     History of Changes
Other Study ID Numbers: R01CA118066, R01CA118066
Study First Received: May 12, 2010
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
LifeSkills Training
Tobacco prevention
Tobacco cessation
Healthy lifestyles
Tobacco control

ClinicalTrials.gov processed this record on September 18, 2014