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.

Study Overview

• Status: Completed
• Conditions: Tobacco Cessation; Tobacco Prevention; Environmental Tobacco Smoke Exposure
• Intervention / Treatment: Behavioral: LifeSkills Training; Behavioral: NRT and Motivational Interviewing (MI); Behavioral: Healthy Lifestyle Behavior Choices

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).

• Study Type: Interventional
• Enrollment (Actual): 688
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Healthy lifestyle behaviors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary prevention of tobacco use in youth	Self-report and salivary cotinine is assessed to measure this outcome	Baseline
Primary prevention of tobacco use in youth	Self-report and salivary cotinine is assessed to measure this outcome.	Year 2
Primary prevention of tobacco use in youth	Self-report and salivary cotinine is assessed to measure this outcome.	Year 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Smoking cessation in parents/guardians	3 months
Smoking cessation in parents/guardians	6 months
Smoking cessation in parents/guardians	Year 1
Smoking cessation in parents/guardians	Year 2
Smoking cessation in parents/guardians	Year 4

Collaborators and Investigators

• Sponsor: Augusta University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Martha S Tingen, PhD, Augusta University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: May 12, 2010
• First Submitted That Met QC Criteria: July 15, 2010
• First Posted (Estimate): July 16, 2010

Study Record Updates

• Last Update Posted (Estimate): February 2, 2015
• Last Update Submitted That Met QC Criteria: January 29, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Tobacco cessation; LifeSkills Training; Tobacco prevention; Healthy lifestyles; Tobacco control
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: R01CA118066 (U.S. NIH Grant/Contract)