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

NCT ID: NCT01164306

Last Updated: 2015-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

688 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2014-05-31

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:

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.

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).

Conditions

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Tobacco Prevention Environmental Tobacco Smoke Exposure Tobacco Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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LifeSkills training

Group Type EXPERIMENTAL

LifeSkills Training

Intervention Type 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.

NRT and Motivational Interviewing (MI)

Intervention Type BEHAVIORAL

For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.

Healthy Lifestyle Behaviors

Group Type ACTIVE_COMPARATOR

Healthy Lifestyle Behavior Choices

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

NRT and Motivational Interviewing (MI)

For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.

Intervention Type BEHAVIORAL

Other Intervention Names

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LifeSkills Training (Botvin's) Healthy lifestyle behaviors NRT is Nicotine Replacement Therapy MI is Motivational Interviewing

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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Martha Tingen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martha S Tingen, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

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Georgia Health Sciences University

Augusta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29292310 (View on PubMed)

Other Identifiers

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R01CA118066

Identifier Type: NIH

Identifier Source: secondary_id

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R01CA118066

Identifier Type: NIH

Identifier Source: org_study_id

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