Trial Outcomes & Findings for PRIDE: Preventing Respiratory Illnesses During Childhood Study (NCT NCT00927264)

NCT ID: NCT00927264

Last Updated: 2017-08-24

Results Overview

Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 350 participants
• Primary outcome timeframe: Measured at Baseline, 3, 6 and 12 months
• Results posted on: 2017-08-24

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	165	165
Overall Study COMPLETED	109	140
Overall Study NOT COMPLETED	56	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PRIDE: Preventing Respiratory Illnesses During Childhood Study

Baseline characteristics by cohort

Measure	Behavioral n=165 Participants 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 n=165 Participants 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 n=330 Participants Total of all reporting groups
Age, Continuous child age	3.81 years STANDARD_DEVIATION 0.81 • n=5 Participants	3.71 years STANDARD_DEVIATION .82 • n=7 Participants	3.76 years STANDARD_DEVIATION 0.82 • n=5 Participants
Age, Continuous caregiver age	32.07 years STANDARD_DEVIATION 8.6 • n=5 Participants	32.12 years STANDARD_DEVIATION 9.18 • n=7 Participants	32.09 years STANDARD_DEVIATION 8.87 • n=5 Participants
Sex: Female, Male Child Gender · Female	87 Participants n=5 Participants	78 Participants n=7 Participants	165 Participants n=5 Participants
Sex: Female, Male Child Gender · Male	78 Participants n=5 Participants	87 Participants n=7 Participants	165 Participants n=5 Participants
Sex: Female, Male Caregiver Gender · Female	140 Participants n=5 Participants	148 Participants n=7 Participants	288 Participants n=5 Participants
Sex: Female, Male Caregiver Gender · Male	25 Participants n=5 Participants	17 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	153 Participants n=5 Participants	149 Participants n=7 Participants	302 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	165 participants n=5 Participants	165 participants n=7 Participants	330 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Baseline, 3, 6 and 12 months

Population: The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact

Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)

Outcome measures

Measure	Behavioral n=165 Participants 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 n=165 Participants 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.
Air Nicotine Levels 12 month	0.55 mg/m^3 Interval 0.07 to 1.37	0.32 mg/m^3 Interval 0.04 to 1.5
Air Nicotine Levels Baseline	1.17 mg/m^3 Interval 0.24 to 2.92	0.58 mg/m^3 Interval 0.08 to 2.01
Air Nicotine Levels 3 month	0.71 mg/m^3 Interval 0.22 to 1.88	0.51 mg/m^3 Interval 0.06 to 1.71
Air Nicotine Levels 6 month	0.75 mg/m^3 Interval 0.22 to 2.07	0.52 mg/m^3 Interval 0.05 to 1.61

SECONDARY outcome

Timeframe: Measured at Baseline, 3, 6 and 12 months

Population: 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.

Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction

Outcome measures

Measure	Behavioral n=165 Participants 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 n=165 Participants 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.
ETS Reduction, as Measured by Child's Cotinine Levels Baseline	4.14 ng/mL Interval 1.8 to 7.5	3.00 ng/mL Interval 1.34 to 6.26
ETS Reduction, as Measured by Child's Cotinine Levels 3 Months	4.14 ng/mL Interval 1.63 to 6.97	3.25 ng/mL Interval 1.24 to 6.41
ETS Reduction, as Measured by Child's Cotinine Levels 6 Months	3.60 ng/mL Interval 1.55 to 7.4	3.04 ng/mL Interval 1.32 to 5.92
ETS Reduction, as Measured by Child's Cotinine Levels 12 Months	4.04 ng/mL Interval 2.13 to 7.17	2.83 ng/mL Interval 1.37 to 6.07

SECONDARY outcome

Timeframe: Measured at Baseline, 3, 6, and 12 months

Population: 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

Number of cold infections child experienced in previous 3 months, reported by caregiver

Outcome measures

Measure	Behavioral n=165 Participants 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 n=165 Participants 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.
Respiratory Function of Child by Self Report of Parent Baseline	1.07 cold infections Standard Deviation 1.06	1 cold infections Standard Deviation 1.00
Respiratory Function of Child by Self Report of Parent 3 Months	0.44 cold infections Standard Deviation 0.56	0.54 cold infections Standard Deviation 0.88
Respiratory Function of Child by Self Report of Parent 6 Months	0.38 cold infections Standard Deviation 0.65	0.36 cold infections Standard Deviation 0.52
Respiratory Function of Child by Self Report of Parent 12 Months	0.32 cold infections Standard Deviation 0.77	0.33 cold infections Standard Deviation 0.51

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Behavioral n=165 Participants 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 n=165 Participants 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.
Health Care Utilization by Child- Self Report From Parent/Caregiver BL Urgent Care Visits	80 Participants	73 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver 3M Urgent Care Visits	18 Participants	15 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver 6M Urgent Care Visits	14 Participants	19 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver 12M Urgent Care Visits	13 Participants	14 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver BL Hospitalizations	10 Participants	14 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver 3M Hospitalizations	4 Participants	3 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver 6M Hospitalizations	1 Participants	2 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver 12M Hospitalizations	1 Participants	2 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver BL Emergency Dept Visit	75 Participants	74 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver 3M Emergency Dept Visit	18 Participants	13 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver 6M Emergency Dept Visit	13 Participants	13 Participants
Health Care Utilization by Child- Self Report From Parent/Caregiver 12M Emergency Dept Visit	9 Participants	14 Participants

SECONDARY outcome

Timeframe: Measured at baseline, 3, 6 and 12 months

Population: The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact

Number of participants endorsing presence of home smoking ban

Outcome measures

Measure	Behavioral n=165 Participants 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 n=165 Participants 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.
Number of Participants Who Report Endorsing a Home Smoking Ban BL	129 Participants	118 Participants
Number of Participants Who Report Endorsing a Home Smoking Ban 3M	80 Participants	89 Participants
Number of Participants Who Report Endorsing a Home Smoking Ban 6M	78 Participants	83 Participants
Number of Participants Who Report Endorsing a Home Smoking Ban 12M	65 Participants	82 Participants

Adverse Events

Behavioral

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Education Only

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Behavioral n=165 participants at risk 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 n=165 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Asthma Hospitalization	0.61% 1/165 • Number of events 1 • Adverse events were collected for enrolled parent/caregiver and child enrolled in study for the duration of their enrollment (1 year)	0.00% 0/165 • Adverse events were collected for enrolled parent/caregiver and child enrolled in study for the duration of their enrollment (1 year)
Surgical and medical procedures Broken Leg Hospitalization	0.00% 0/165 • Adverse events were collected for enrolled parent/caregiver and child enrolled in study for the duration of their enrollment (1 year)	0.61% 1/165 • Number of events 1 • Adverse events were collected for enrolled parent/caregiver and child enrolled in study for the duration of their enrollment (1 year)

Other adverse events

Measure	Behavioral n=165 participants at risk 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 n=165 participants at risk 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.
Social circumstances Family Stress Related to Smoking	7.9% 13/165 • Number of events 13 • Adverse events were collected for enrolled parent/caregiver and child enrolled in study for the duration of their enrollment (1 year)	6.1% 10/165 • Number of events 10 • Adverse events were collected for enrolled parent/caregiver and child enrolled in study for the duration of their enrollment (1 year)

Additional Information

Cynthia Rand, Ph.D.

Johns Hopkins University

Phone: 410-550-0487

Email: crand@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place