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PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)

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.
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:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

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
Enrollment 350
Recruitment Details 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 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.
Arm/Group Title Behavioral Education Only
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 165 165
Completed 109 140
Not Completed 56 25
Arm/Group Title Behavioral Education Only Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 165 165 330
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 165 participants 165 participants 330 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 165 participants 330 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 165 participants 330 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]
Measure Description: Race of child enrolled in study
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 165 participants 165 participants 330 participants
165 165 330
[1]
Measure Description: Participant unit of measure is child + consented caregiver
1.Primary Outcome
Title Air Nicotine Levels
Hide Description Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)
Time Frame Measured at Baseline, 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact
Arm/Group Title Behavioral Education Only
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 165 165
Median (Inter-Quartile Range)
Unit of Measure: mg/m^3
Baseline Number Analyzed 164 participants 164 participants
1.17
(0.24 to 2.92)
0.58
(0.08 to 2.01)
3 month Number Analyzed 122 participants 134 participants
0.71
(0.22 to 1.88)
0.51
(0.06 to 1.71)
6 month Number Analyzed 111 participants 128 participants
0.75
(0.22 to 2.07)
0.52
(0.05 to 1.61)
12 month Number Analyzed 105 participants 132 participants
0.55
(0.07 to 1.37)
0.32
(0.04 to 1.5)
2.Secondary Outcome
Title ETS Reduction, as Measured by Child's Cotinine Levels
Hide Description Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction
Time Frame Measured at Baseline, 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact, samples not able to be analyzed due to insufficient quantity of saliva collected, or child not available during assessment.
Arm/Group Title Behavioral Education Only
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 165 165
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
Baseline Number Analyzed 162 participants 162 participants
4.14
(1.8 to 7.5)
3.00
(1.34 to 6.26)
3 Months Number Analyzed 123 participants 136 participants
4.14
(1.63 to 6.97)
3.25
(1.24 to 6.41)
6 Months Number Analyzed 117 participants 138 participants
3.60
(1.55 to 7.40)
3.04
(1.32 to 5.92)
12 Months Number Analyzed 111 participants 139 participants
4.04
(2.13 to 7.17)
2.83
(1.37 to 6.07)
3.Secondary Outcome
Title Respiratory Function of Child by Self Report of Parent
Hide Description Number of cold infections child experienced in previous 3 months, reported by caregiver
Time Frame Measured at Baseline, 3, 6, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed differs at each time point due to missing data. Reasons for missing include unable to contact or caregiver refused or did not fully complete survey
Arm/Group Title Behavioral Education Only
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 165 165
Mean (Standard Deviation)
Unit of Measure: cold infections
Baseline Number Analyzed 164 participants 165 participants
1.07  (1.06) 1  (1.00)
3 Months Number Analyzed 126 participants 138 participants
0.44  (0.56) 0.54  (0.88)
6 Months Number Analyzed 121 participants 140 participants
0.38  (0.65) 0.36  (0.52)
12 Months Number Analyzed 109 participants 140 participants
0.32  (0.77) 0.33  (0.51)
4.Secondary Outcome
Title Health Care Utilization by Child- Self Report From Parent/Caregiver
Hide Description 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
Time Frame Measured at baseline and 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Behavioral Education Only
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 165 165
Measure Type: Count of Participants
Unit of Measure: Participants
BL Urgent Care Visits
80
  48.5%
73
  44.2%
3M Urgent Care Visits
18
  10.9%
15
   9.1%
6M Urgent Care Visits
14
   8.5%
19
  11.5%
12M Urgent Care Visits
13
   7.9%
14
   8.5%
BL Hospitalizations
10
   6.1%
14
   8.5%
3M Hospitalizations
4
   2.4%
3
   1.8%
6M Hospitalizations
1
   0.6%
2
   1.2%
12M Hospitalizations
1
   0.6%
2
   1.2%
BL Emergency Dept Visit
75
  45.5%
74
  44.8%
3M Emergency Dept Visit
18
  10.9%
13
   7.9%
6M Emergency Dept Visit
13
   7.9%
13
   7.9%
12M Emergency Dept Visit
9
   5.5%
14
   8.5%
5.Secondary Outcome
Title Number of Participants Who Report Endorsing a Home Smoking Ban
Hide Description Number of participants endorsing presence of home smoking ban
Time Frame Measured at baseline, 3, 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact
Arm/Group Title Behavioral Education Only
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 165 165
Measure Type: Count of Participants
Unit of Measure: Participants
BL Number Analyzed 163 participants 165 participants
129
  79.1%
118
  71.5%
3M Number Analyzed 126 participants 138 participants
80
  63.5%
89
  64.5%
6M Number Analyzed 121 participants 140 participants
78
  64.5%
83
  59.3%
12M Number Analyzed 109 participants 140 participants
65
  59.6%
82
  58.6%
Time Frame Adverse events were collected for enrolled parent/caregiver and child enrolled in study for the duration of their enrollment (1 year)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Behavioral Education Only
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Behavioral Education Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Behavioral Education Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/165 (0.61%)      1/165 (0.61%)    
Respiratory, thoracic and mediastinal disorders     
Asthma Hospitalization  [1]  1/165 (0.61%)  1 0/165 (0.00%)  0
Surgical and medical procedures     
Broken Leg Hospitalization  [2]  0/165 (0.00%)  0 1/165 (0.61%)  1
Indicates events were collected by systematic assessment
[1]
asthma exacerbation
[2]
broken leg
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Behavioral Education Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/165 (7.88%)      10/165 (6.06%)    
Social circumstances     
Family Stress Related to Smoking  [1]  13/165 (7.88%)  13 10/165 (6.06%)  10
Indicates events were collected by systematic assessment
[1]
Parent/caregiver may discuss smoking exposure with others in household- we expect that this may have caused some sources of stress
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
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