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PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927264
First Posted: June 24, 2009
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: September 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Condition: Tobacco Smoke Pollution
Interventions: Behavioral: Motivational Interviewing Intervention for ETS Reduction
Behavioral: Educational Program for ETS Reduction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Caregivers of children were recruited from 16 Baltimore City Head Start programs from April 2009 to August 2012 with final data collection ending August 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Caregivers had to complete a baseline assessment prior to randomization and reported information for themselves and the targeted child due to the young age of the child. 350 caregivers were recruited but only 330 were randomized because 20 did not complete the baseline assessment.

Reporting Groups
  Description
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.

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.

Education Only

Participants will receive only educational program for ETS reduction.

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


Participant Flow:   Overall Study
    Behavioral   Education Only
STARTED   165   165 
COMPLETED   109   140 
NOT COMPLETED   56   25 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible caregivers had to be the parent or legal guardian of a child aged 6 months to 6 years, who reported one or more smokers living in the home, and who spoke English. The enrolled caregiver did not have to be the smoker.

Reporting Groups
  Description
Behavioral

Motivational Interviewing Intervention Plus Education

Caregivers of children will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction.

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.

Education Only

Caregivers will receive only educational program for ETS reduction.

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

Total Total of all reporting groups

Baseline Measures
   Behavioral   Education Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 165   165   330 
Age 
[Units: Years]
Mean (Standard Deviation)
     
child age   3.81  (0.81)   3.71  (.82)   3.76  (0.82) 
caregiver age   32.07  (8.6)   32.12  (9.18)   32.09  (8.87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Child Gender       
Female      87  52.7%      78  47.3%      165  50.0% 
Male      78  47.3%      87  52.7%      165  50.0% 
Caregiver Gender       
Female      140  84.8%      148  89.7%      288  87.3% 
Male      25  15.2%      17  10.3%      42  12.7% 
Race (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      153  92.7%      149  90.3%      302  91.5% 
White      10   6.1%      9   5.5%      19   5.8% 
More than one race      2   1.2%      7   4.2%      9   2.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
[1] Race of child enrolled in study
Region of Enrollment [1] 
[Units: Participants]
     
United States   165   165   330 
[1] Participant unit of measure is child + consented caregiver


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Air Nicotine Levels   [ Time Frame: Measured at Baseline, 3, 6 and 12 months ]

2.  Secondary:   ETS Reduction, as Measured by Child's Cotinine Levels   [ Time Frame: Measured at Baseline, 3, 6 and 12 months ]

3.  Secondary:   Respiratory Function of Child by Self Report of Parent   [ Time Frame: Measured at Baseline, 3, 6, and 12 months ]

4.  Secondary:   Health Care Utilization by Child- Self Report From Parent/Caregiver   [ Time Frame: Measured at baseline and 3, 6 and 12 months ]

5.  Secondary:   Number of Participants Who Report Endorsing a Home Smoking Ban   [ Time Frame: Measured at baseline, 3, 6 and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cynthia Rand, Ph.D.
Organization: Johns Hopkins University
phone: 410-550-0487
e-mail: crand@jhmi.edu


Publications of Results:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00927264     History of Changes
Other Study ID Numbers: 664
R18HL092901-01 ( U.S. NIH Grant/Contract )
First Submitted: June 23, 2009
First Posted: June 24, 2009
Results First Submitted: September 17, 2015
Results First Posted: August 24, 2017
Last Update Posted: August 24, 2017