- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00927264
PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)
A+ Head Start Intervention for Smoke Free Homes
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21206
- Johns Hopkins University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Child enrolled in Baltimore City Head Start
- Smoker living in the home with child
Exclusion Criteria:
- No smoker in home with child
- Does not speak English
- Is enrolled in other respiratory research study
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Behavioral
Motivational Interviewing Intervention Plus Education Caregivers will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program 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.
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Aktywny komparator: Education Only
Caregivers will receive only educational program for ETS reduction.
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An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Air Nicotine Levels
Ramy czasowe: Measured at Baseline, 3, 6 and 12 months
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Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)
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Measured at Baseline, 3, 6 and 12 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
ETS Reduction, as Measured by Child's Cotinine Levels
Ramy czasowe: Measured at Baseline, 3, 6 and 12 months
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Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction
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Measured at Baseline, 3, 6 and 12 months
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Respiratory Function of Child by Self Report of Parent
Ramy czasowe: Measured at Baseline, 3, 6, and 12 months
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Number of cold infections child experienced in previous 3 months, reported by caregiver
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Measured at Baseline, 3, 6, and 12 months
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Health Care Utilization by Child- Self Report From Parent/Caregiver
Ramy czasowe: Measured at baseline and 3, 6 and 12 months
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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
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Measured at baseline and 3, 6 and 12 months
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Number of Participants Who Report Endorsing a Home Smoking Ban
Ramy czasowe: Measured at baseline, 3, 6 and 12 months
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Number of participants endorsing presence of home smoking ban
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Measured at baseline, 3, 6 and 12 months
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Cynthia S Rand, PhD, Johns Hopkins University
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 664
- R18HL092901-01 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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