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NCT01164306 Clinical Trial

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

Tobacco Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01164306
Other study ID # R01CA118066
Secondary ID R01CA118066
Status Completed
Phase N/A
First received May 12, 2010
Last updated January 29, 2015
Start date September 2007
Est. completion date May 2014

Study information
Verified date January 2015
Source Georgia Regents University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 688
Est. completion date May 2014
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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.
• 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.
• NRT and Motivational Interviewing (MI)
For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.

Locations
Country Name City State
United States Georgia Health Sciences University Augusta Georgia

Sponsors (2)
Lead Sponsor Collaborator
Georgia Regents University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary prevention of tobacco use in youth Self-report and salivary cotinine is assessed to measure this outcome Baseline No
Primary Primary prevention of tobacco use in youth Self-report and salivary cotinine is assessed to measure this outcome. Year 2 No
Primary Primary prevention of tobacco use in youth Self-report and salivary cotinine is assessed to measure this outcome. Year 4 No
Secondary Smoking cessation in parents/guardians 3 months No
Secondary Smoking cessation in parents/guardians 6 months No
Secondary Smoking cessation in parents/guardians Year 1 No
Secondary Smoking cessation in parents/guardians Year 2 No
Secondary Smoking cessation in parents/guardians Year 4 No
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