PRIDE: Preventing Respiratory Illnesses During Childhood Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Cynthia Rand, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00927264
First received: June 23, 2009
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Tobacco Smoke Pollution
Behavioral: Motivational Interviewing Intervention for ETS Reduction
Behavioral: Educational Program for ETS Reduction
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A+ Head Start Intervention for Smoke Free Homes

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ETS reduction, as measured by child's cotinine levels [ Time Frame: Measured at baseline, 3, 6 and 12 months. ] [ Designated as safety issue: No ]
  • Respiratory function of child by self report of parent [ Time Frame: Measured at baseline, 3, 6 & 12 months ] [ Designated as safety issue: No ]
  • Health care utilizations by self report of parent [ Time Frame: Measured at baseline and 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Changes in smoking in home by household members [ Time Frame: Measured at baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Head Start staff knowledge, attitudes and practices regarding ETS exposure and reduction [ Time Frame: Measured at baseline and 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: January 2009
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral

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.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • child enrolled in Baltimore city Head Start
  • smoker in home

Exclusion Criteria:

  • no smoker in home
  • does not speak English
  • is enrolled in other respiratory research study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927264

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21206
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Cynthia S Rand, PhD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cynthia Rand, Ph.D., Professor of Medicine and Psychiatry/Director, The Johns Hopkins Adherence Research Center, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00927264     History of Changes
Other Study ID Numbers: 664, R18HL092901-01
Study First Received: June 23, 2009
Last Updated: March 13, 2014
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
tobacco smoke exposure smoking

ClinicalTrials.gov processed this record on September 18, 2014