PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)
|Tobacco Smoke Pollution||Behavioral: Motivational Interviewing Intervention for ETS Reduction Behavioral: Educational Program for ETS Reduction||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||A+ Head Start Intervention for Smoke Free Homes|
- Air nicotine levels, as an indicator of child's exposure to environmental tobacco smoke (ETS) [ Time Frame: Measured at baseline, 3, 6 and 12 months. ]
- ETS reduction, as measured by child's cotinine levels [ Time Frame: Measured at baseline, 3, 6 and 12 months. ]
- Respiratory function of child by self report of parent [ Time Frame: Measured at baseline, 3, 6 & 12 months ]
- Health care utilizations by self report of parent [ Time Frame: Measured at baseline and 3, 6 and 12 months ]
- Changes in smoking in home by household members [ Time Frame: Measured at baseline, 3, 6 and 12 months ]
- Head Start staff knowledge, attitudes and practices regarding ETS exposure and reduction [ Time Frame: Measured at baseline and 3, 6 and 12 months ]
|Study Start Date:||January 2009|
|Study Completion Date:||June 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Motivational Interviewing Intervention Plus Education
Participants will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.
Behavioral: Motivational Interviewing Intervention for ETS Reduction
The intervention is designed to motivate families to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation. Families will receive 2 home visits & 2 telephone session, both with a health counselor. Families 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.
Active Comparator: Education Only
Participants will receive only educational program for ETS reduction.
Behavioral: Educational Program for ETS Reduction
An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927264
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21206|
|Principal Investigator:||Cynthia S Rand, PhD||Johns Hopkins University|