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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00056927
Other study ID # 2R01HD36514-5
Secondary ID
Status Completed
Phase N/A
First received March 26, 2003
Last updated September 29, 2006
Start date September 1997
Est. completion date August 2002

Study information

Verified date July 2005
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether an anti-smoking program for parents who smoke will lower the odds that their children will start smoking. The study will evaluate an activity-based program for parents and their children. The program is home-based and uses the mail for program delivery.


Description:

Youth whose parents smoke cigarettes are at high risk for early initiation of cigarette smoking, and youth who first smoke cigarettes during childhood are at high risk for subsequent addiction to tobacco. Parents influence their children's perceptions of the prevalence of smoking, the acceptability of smoking, the accessibility of cigarettes, and the personal and social consequences of smoking. All parents, including parents who smoke, can engage in anti-smoking socialization, which may lower children's risk of smoking.

Although there are some programs available that are directed at preventing initiation of smoking during childhood, none of these prevention programs engage parents who smoke in altering children's smoking-specific socialization. This study will evaluate a program to change smoking-specific socialization of children in households where parents smoke cigarettes.

Consenting volunteers will be randomly assigned to either treatment (anti-smoking socialization program) or control groups. Parents in the treatment group will participate in the "Smoke-free Kids" program and receive activity magazines, newsletters, and support calls. Parents in the control group will receive a fact sheet about youth smoking. Parents involved in the study will be assessed through a telephone interview 1 month after completion of the three-month anti-smoking program. Assenting children will complete surveys administered at school at 12, 24, and 36 months after completion of the anti-smoking program. Primary and secondary dependent variables include initiation of cigarette smoking and susceptibility to cigarette smoking by children. The child survey will also assess risk and protective factors.


Recruitment information / eligibility

Status Completed
Enrollment 1007
Est. completion date August 2002
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years and older
Eligibility Inclusion Criteria

- Parents or guardians who smoke

- Have children in the 3rd grade

- Belong to participating school districts in North Carolina, South Carolina, or Colorado

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


Intervention

Behavioral:
Anti-smoking Socialization Program


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

References & Publications (1)

Jackson C, Dickinson D. Can parents who smoke socialise their children against smoking? Results from the Smoke-free Kids intervention trial. Tob Control. 2003 Mar;12(1):52-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Initiation of cigarette smoking -- 3 years post treatment
Secondary Susceptibility for initiation of cigarette smoking -- 1 year post treatment
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