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

Study Overview
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Brief Summary
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The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at: preventing tobacco initiation in youth promoting anti-tobacco socialization in the home decreasing environmental tobacco smoke exposure in children 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.

Detailed Description
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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).

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

Conditions
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Tobacco Prevention, Environmental Tobacco Smoke Exposure, Tobacco Cessation

Intervention / Treatment
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* Behavioral: LifeSkills Training
* Behavioral: Healthy Lifestyle Behavior Choices
* Behavioral: NRT and Motivational Interviewing (MI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LifeSkills training<br> | Behavioral: LifeSkills Training<br>* 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.<br>* Other names: LifeSkills Training (Botvin's);Behavioral: NRT and Motivational Interviewing (MI)<br>* For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.<br>* Other names: MI is Motivational Interviewing;|
| Active Comparator: Healthy Lifestyle Behaviors<br> | Behavioral: Healthy Lifestyle Behavior Choices<br>* 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.<br>* Other names: Healthy lifestyle behaviors;|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LifeSkills Training, Tobacco prevention, Tobacco cessation, Healthy lifestyles, Tobacco control