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PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)

23 de agosto de 2017 actualizado por: Johns Hopkins University

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

350

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21206
        • Johns Hopkins University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 meses a 6 años (Niño)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Comparador activo: Education Only
Caregivers will receive only educational program for ETS reduction.
An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Air Nicotine Levels
Periodo de tiempo: Measured at Baseline, 3, 6 and 12 months
Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)
Measured at Baseline, 3, 6 and 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ETS Reduction, as Measured by Child's Cotinine Levels
Periodo de tiempo: Measured at Baseline, 3, 6 and 12 months
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
Periodo de tiempo: Measured at Baseline, 3, 6, and 12 months
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
Periodo de tiempo: 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
Measured at baseline and 3, 6 and 12 months
Number of Participants Who Report Endorsing a Home Smoking Ban
Periodo de tiempo: Measured at baseline, 3, 6 and 12 months
Number of participants endorsing presence of home smoking ban
Measured at baseline, 3, 6 and 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Cynthia S Rand, PhD, Johns Hopkins University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2009

Finalización primaria (Actual)

1 de enero de 2013

Finalización del estudio (Actual)

1 de junio de 2013

Fechas de registro del estudio

Enviado por primera vez

23 de junio de 2009

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2009

Publicado por primera vez (Estimar)

24 de junio de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de agosto de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

23 de agosto de 2017

Última verificación

1 de agosto de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 664
  • R18HL092901-01 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

We will not be sharing individual participant data

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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