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| ID | Type | Description | Link |
|---|---|---|---|
| R18HL092901-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Education Only | Active Comparator | Caregivers will receive only educational program for ETS reduction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ETS Reduction, as Measured by Child's Cotinine Levels | Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction | Measured at Baseline, 3, 6 and 12 months |
| Respiratory Function of Child by Self Report of Parent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia S Rand, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24821270 | Result | 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. |
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We will not be sharing individual participant data
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Air Nicotine Levels | Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS) | The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact | Posted | Median | Inter-Quartile Range | mg/m^3 | Measured at Baseline, 3, 6 and 12 months |
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Adverse events were collected for enrolled parent/caregiver and child enrolled in study for the duration of their enrollment (1 year)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | asthma exacerbation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Family Stress Related to Smoking | Social circumstances | Systematic Assessment | Parent/caregiver may discuss smoking exposure with others in household- we expect that this may have caused some sources of stress |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Rand, Ph.D. | Johns Hopkins University | 410-550-0487 | crand@jhmi.edu |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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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.
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| Educational Program for ETS Reduction | Behavioral | An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure. |
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Number of cold infections child experienced in previous 3 months, reported by caregiver
| 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 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 at baseline, 3, 6 and 12 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Race of child enrolled in study | Count of Participants | Participants |
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| Region of Enrollment | Participant unit of measure is child + consented caregiver | Number | participants |
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| OG001 | 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. |
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| Secondary | ETS Reduction, as Measured by Child's Cotinine Levels | Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction | 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. | Posted | Median | Inter-Quartile Range | ng/mL | Measured at Baseline, 3, 6 and 12 months |
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| Secondary | Respiratory Function of Child by Self Report of Parent | Number of cold infections child experienced in previous 3 months, reported by caregiver | 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 | Posted | Mean | Standard Deviation | cold infections | Measured at Baseline, 3, 6, and 12 months |
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| Secondary | 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 | Posted | Count of Participants | Participants | Measured at baseline and 3, 6 and 12 months |
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| Secondary | Number of Participants Who Report Endorsing a Home Smoking Ban | Number of participants endorsing presence of home smoking ban | The number analyzed differs at each time point due to missing data. Reasons for missing data include unable to contact | Posted | Count of Participants | Participants | Measured at baseline, 3, 6 and 12 months |
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| 1 |
| 165 |
| 13 |
| 165 |
| EG001 | 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. | 1 | 165 | 10 | 165 |
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| Broken Leg Hospitalization | Surgical and medical procedures | Systematic Assessment | broken leg |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| 3 Months |
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| 6 Months |
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| 12 Months |
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| 3 Months |
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| 6 Months |
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| 12 Months |
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| 6M Urgent Care Visits |
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| 12M Urgent Care Visits |
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| BL Hospitalizations |
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| 3M Hospitalizations |
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| 6M Hospitalizations |
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| 12M Hospitalizations |
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| BL Emergency Dept Visit |
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| 3M Emergency Dept Visit |
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| 6M Emergency Dept Visit |
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| 12M Emergency Dept Visit |
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| 3M |
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| 6M |
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| 12M |
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