Clinical Trials Directory

Trials / Completed

CompletedNCT00927264

PRIDE: Preventing Respiratory Illnesses During Childhood Study

A+ Head Start Intervention for Smoke Free Homes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
350 (actual)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
6 Months – 6 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMotivational Interviewing Intervention for ETS ReductionThe intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Caregivers will receive 2 home visits \& 2 telephone session, both with a health counselor. Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels. The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure. Any and all household members may participate in the intervention visits but are not required to do so.
BEHAVIORALEducational Program for ETS ReductionAn Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.

Timeline

Start date
2009-01-01
Primary completion
2013-01-01
Completion
2013-06-01
First posted
2009-06-24
Last updated
2017-08-24
Results posted
2017-08-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00927264. Inclusion in this directory is not an endorsement.