- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00927264
PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)
A+ Head Start Intervention for Smoke Free Homes
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Maryland
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Baltimore, Maryland, Spojené státy, 21206
- Johns Hopkins University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Air Nicotine Levels
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
ETS Reduction, as Measured by Child's Cotinine Levels
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Cynthia S Rand, PhD, Johns Hopkins University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 664
- R18HL092901-01 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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Klinické studie na Motivational Interviewing Intervention for ETS Reduction
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University of North Carolina, Chapel HillCenters for Disease Control and PreventionDokončenoHIV infekceSpojené státy