PRIDE: Preventing Respiratory Illnesses During Childhood Study

Study Overview
=================
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.

Official Title
-----------------
A+ Head Start Intervention for Smoke Free Homes

Conditions
-----------------
Tobacco Smoke Pollution

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing Intervention for ETS Reduction
* Behavioral: Educational Program for ETS Reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral<br>Motivational Interviewing Intervention Plus Education Caregivers 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<br>* The 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.<br>|
| Active Comparator: Education Only<br>Caregivers will receive only educational program for ETS reduction. | Behavioral: Educational Program for ETS Reduction<br>* An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air Nicotine Levels | Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS) | Measured at Baseline, 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ETS Reduction, as Measured by Child's Cotinine Levels | Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction | Measured at Baseline, 3, 6 and 12 months | 
| Respiratory Function of Child by Self Report of Parent | Number of cold infections child experienced in previous 3 months, reported by caregiver | Measured at Baseline, 3, 6, and 12 months | 
| Health Care Utilization by Child- Self Report From Parent/Caregiver | 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 | Measured at baseline and 3, 6 and 12 months | 
| Number of Participants Who Report Endorsing a Home Smoking Ban | Number of participants endorsing presence of home smoking ban | Measured at baseline, 3, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tobacco smoke exposure smoking