PRIDE: Preventing Respiratory Illnesses During Childhood Study

Tobacco Smoke Pollution Clinical Trial

— PRIDE  

Official title:

A+ Head Start Intervention for Smoke Free Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927264
• Other study ID #: 664
• Secondary ID: R18HL092901-01
• Status: Completed
• Phase: N/A
• First received: June 23, 2009
• Last updated: August 23, 2017
• Start date: January 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Smoke Pollution

Intervention

Behavioral:
• Motivational Interviewing Intervention for ETS Reduction
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.
• Educational Program for ETS Reduction
An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Eakin MN, Rand CS, Borrelli B, Bilderback A, Hovell M, Riekert KA. Effectiveness of motivational interviewing to reduce head start children's secondhand smoke exposure. a randomized clinical trial. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1530-7. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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