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PRIDE: Preventing Respiratory Illnesses During Childhood Study

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Johns Hopkins University

Status

Completed

Conditions

Tobacco Smoke Pollution

Treatments

Behavioral: Educational Program for ETS Reduction
Behavioral: Motivational Interviewing Intervention for ETS Reduction

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00927264
R18HL092901-01 (U.S. NIH Grant/Contract)
664

Details and patient eligibility

About

Environmental tobacco smoke (ETS0, also known as secondhand smoke, is the combination of smoke given off by the burning end of a tobacco product and the smoke exhaled by the smoker. Children exposed to ETS are at an increased risk of sudden infant death syndrome (SIDS), ear infections, colds, pneumonia, bronchitis and more severe asthma. ETS can also slow the growth of children's lungs and can cause them to cough, wheeze and fell breathless. The purpose of this study is to determine the effectiveness of a motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in a Head Start program and whose households include a smoker.

Full description

About 90% of nonsmoking people in the US are exposed to ETS. More than 50 chemicals identified in ETS have been found to cause cancer and exposure has been linked to heart disease in adults and SIDS, ear infections and numerous respiratory problems, including asthma in children. In 2007, the Environmental Protection Agency and the Office of Head Start-a national program that provides economically disadvantaged children services to enhance their social and cognitive development-announced a new initiative to promote smoke-free homes for children in Head Start programs. Because Head Start reaches high-risk, low-income preschool children, it offers a timely intervention for reducing children's exposure to ETS. Head Start also attempts to engage parents, which is an important component of reducing household ETS exposure among children. This study will determine the effectiveness of a home-delivered, motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in the Baltimore City Head Start program and whose households include a smoker.

Participation in this study will last 1 year. First, all participating families will be visited at home by a study staff person who will attach special filters that will track the amount of nicotine in the various rooms of the house. During this initial visit, the participating children will undergo weight and height measurements and saliva sampling. About a week later, the filters will be collected, a 2nd saliva samples will be taken and parents will be interviewed about their family and child's health. Families will then be randomly assigned to one of two groups. Both groups will received educational information about reducing tobacco smoke exposure. One group will also receive the home-delivered, motivational interviewing-based program aimed to reduce ETS. This program will consist of 2 home visits and 2 phone calls, both led by health counselor who will teach participants how to reduce their child's exposure to tobacco smoke. The home visits will occur during Weeks 1 & 2 and the phone calls will occur during Weeks 3 & 6. Follow-up visits for all participating families will occur at Months 3,6 and 12 and will involve repeat filter testing, saliva monitoring and interviews.

Enrollment

350 patients

Sex

All

Ages

6 months to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Child enrolled in Baltimore City Head Start
  • Smoker living in the home with child

Exclusion criteria

  • No smoker in home with child
  • Does not speak English
  • Is enrolled in other respiratory research study

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

350 participants in 2 patient groups

Behavioral
Experimental group
Description:
Motivational Interviewing Intervention Plus Education Caregivers will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Treatment:
Behavioral: Motivational Interviewing Intervention for ETS Reduction
Education Only
Active Comparator group
Description:
Caregivers will receive only educational program for ETS reduction.
Treatment:
Behavioral: Educational Program for ETS Reduction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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