PRIDE: Preventing Respiratory Illnesses During Childhood Study

NCT00927264 | Completed Results DMC

• 2 other identifiers: 664R18HL092901-01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Smoke Pollution

Keywords

tobacco smoke exposure smoking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• ETS Reduction, as Measured by Child's Cotinine Levels

  Measured at Baseline, 3, 6 and 12 months

• Respiratory Function of Child by Self Report of Parent

  Measured at Baseline, 3, 6, and 12 months

• Health Care Utilization by Child- Self Report From Parent/Caregiver

  Measured at baseline and 3, 6 and 12 months

• Number of Participants Who Report Endorsing a Home Smoking Ban

  Measured at baseline, 3, 6 and 12 months

Study Arms (2)

Behavioral

EXPERIMENTAL

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

Education Only

ACTIVE COMPARATOR

Caregivers will receive only educational program for ETS reduction.

Behavioral: Educational Program for ETS Reduction

Interventions

Motivational Interviewing Intervention for ETS Reduction BEHAVIORAL

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.

Behavioral

Educational Program for ETS Reduction BEHAVIORAL

An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.

Education Only

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child enrolled in Baltimore City Head Start
• Smoker living in the home with child

You may not qualify if:

• No smoker in home with child
• Does not speak English
• Is enrolled in other respiratory research study

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21206, United States

Location

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

  PMID: 24821270 RESULT

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Cynthia Rand, Ph.D.
• Organization: Johns Hopkins University

crand@jhmi.edu

410-550-0487

Study Officials

• Cynthia S Rand, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 24, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 24, 2017
• Results First Posted: August 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)