PRIDE: Preventing Respiratory Illnesses During Childhood Study

Not Applicable

Completed

• Conditions: Tobacco Smoke Pollution
• Interventions: Behavioral: Educational Program for ETS Reduction; Behavioral: Motivational Interviewing Intervention for ETS Reduction

• Registration Number: NCT00927264
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-23
• Study First Posted: 2009-06-24
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Results First Submitted: 2015-09-17
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-23
• Last Update Submitted: 2017-08-23
• Results First Posted: 2017-08-24
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Air Nicotine Levels	Measured at Baseline, 3, 6 and 12 months	Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Report Endorsing a Home Smoking Ban	Measured at baseline, 3, 6 and 12 months	Number of participants endorsing presence of home smoking ban
Health Care Utilization by Child- Self Report From Parent/Caregiver	Measured at baseline and 3, 6 and 12 months	Parent caregiver reported urgent care visits, number of hospitalizations, and number of emergency department visits in the 12 months prior for child enrolled in study
ETS Reduction, as Measured by Child's Cotinine Levels	Measured at Baseline, 3, 6 and 12 months	Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction
Respiratory Function of Child by Self Report of Parent	Measured at Baseline, 3, 6, and 12 months	Number of cold infections child experienced in previous 3 months, reported by caregiver

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States