Tobacco Smoke PollutionPRIDENCT00927264
PRIDE: Preventing Respiratory Illnesses During Childhood Study
A study testing Motivational Interviewing Intervention for ETS Reduction and Educational Program for ETS Reduction in people with Tobacco Smoke Pollution, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoke Pollution
- What is being tested?
- Motivational Interviewing Intervention for ETS Reduction and Educational Program for ETS Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child enrolled in Baltimore City Head Start
- Smoker living in the home with child
Who cannot join
- No smoker in home with child
- Does not speak English
- Is enrolled in other respiratory research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A+ Head Start Intervention for Smoke Free Homes
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.
Read the 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.
- Conditions
- Tobacco Smoke Pollution
- Being tested
- Motivational Interviewing Intervention for ETS Reduction, Educational Program for ETS Reduction
- Keywords
- tobacco smoke exposure smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing Intervention for ETS ReductionBehavioural
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.
Educational Program for ETS ReductionBehavioural
An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motivational Interviewing Intervention for ETS Reduction |
| Education Only | Active comparator | Caregivers will receive only educational program for ETS reduction. Receives: Behavioral: Educational Program for ETS Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Air Nicotine Levels
Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)
Measured: Measured at Baseline, 3, 6 and 12 months
Secondary outcomes (4)
ETS Reduction, as Measured by Child's Cotinine Levels
Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction
Measured: Measured at Baseline, 3, 6 and 12 months
Respiratory Function of Child by Self Report of Parent
Number of cold infections child experienced in previous 3 months, reported by caregiver
Measured: Measured at Baseline, 3, 6, and 12 months
Health Care Utilization by Child- Self Report From Parent/Caregiver
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
Measured: Measured at baseline and 3, 6 and 12 months
Number of Participants Who Report Endorsing a Home Smoking Ban
Number of participants endorsing presence of home smoking ban
Measured: Measured at baseline, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Smoke PollutionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Cynthia S Rand, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927264
- Sponsor's protocol ID
- 664
- Other IDs
- R18HL092901-01
- Acronym
- PRIDE
- Status last verified
- Aug 2017
- First submitted
- 23 Jun 2009
- Last updated
- 24 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: We will not be sharing individual participant data
Publications
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.
PubMed 24821270
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A+ Head Start Intervention for Smoke Free Homes
- ClinicalTrials.gov ID
- NCT00927264
- Acronym / sponsor ID
- PRIDE / 664
- Conditions
- Tobacco Smoke Pollution
- Keywords
- tobacco smoke exposure smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Posted 24 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Experimental | Behavioral: Motivational Interviewing Intervention for ETS ReductionMotivational Interviewing Intervention Plus Education Caregivers will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction. |
| Education Only | Active comparator | Behavioral: Educational Program for ETS ReductionCaregivers will receive only educational program for ETS reduction. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child enrolled in Baltimore City Head Start
- Smoker living in the home with child
Key exclusion criteria (3 listed)
- No smoker in home with child
- Does not speak English
- Is enrolled in other respiratory research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing Intervention for ETS ReductionThe 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. | Behavioural | Behavioral |
| Educational Program for ETS ReductionAn Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure. | Behavioural | Education Only |
Primary outcome
Air Nicotine Levels
Time frame: Measured at Baseline, 3, 6 and 12 months
Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)
4 secondary outcomes
ETS Reduction, as Measured by Child's Cotinine Levels
Time frame: Measured at Baseline, 3, 6 and 12 months
Respiratory Function of Child by Self Report of Parent
Time frame: Measured at Baseline, 3, 6, and 12 months
Health Care Utilization by Child- Self Report From Parent/Caregiver
Time frame: Measured at baseline and 3, 6 and 12 months
Number of Participants Who Report Endorsing a Home Smoking Ban
Time frame: Measured at baseline, 3, 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24821270Eakin 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.
- Individual participant dataSharing planned: No. We will not be sharing individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia S Rand, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing Intervention for ETS Reduction and Educational Program for ETS Reduction in people with Tobacco Smoke Pollution, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Air Nicotine Levels (time frame: Measured at Baseline, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00927264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.