PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)

• ClinicalTrials.gov Identifier: NCT00927264
• Recruitment Status: Completed
• First Posted: June 24, 2009
• Results First Posted: August 24, 2017
• Last Update Posted: August 24, 2017
• Sponsor: Johns Hopkins University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tobacco Smoke Pollution	Behavioral: Motivational Interviewing Intervention for ETS Reduction; Behavioral: Educational Program for ETS Reduction	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Investigator)
• Masking Description: For masking we were unable to mask the caregiver and child participant since they knew if they were receiving intervention component. The investigator was masked, but outcome assessor may have known group assignment.
• Primary Purpose: Prevention
• Official Title: A+ Head Start Intervention for Smoke Free Homes
• Study Start Date: January 2009
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Behavioral; 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; 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.
Active Comparator: Education Only; Caregivers 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.

Outcome Measures

Primary Outcome Measures :

1. Air Nicotine Levels [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21206

Sponsors and Collaborators

Johns Hopkins University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Cynthia S Rand, PhD; Johns Hopkins University

More Information

Publications of Results:

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. doi: 10.1164/rccm.201404-0618OC.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00927264
• Other Study ID Numbers: 664; R18HL092901-01 ( U.S. NIH Grant/Contract )
• First Posted: June 24, 2009
• Results First Posted: August 24, 2017
• Last Update Posted: August 24, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: We will not be sharing individual participant data

Keywords provided by Johns Hopkins University:

tobacco smoke exposure smoking