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PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)

23 août 2017 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

350

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Maryland
      • Baltimore, Maryland, États-Unis, 21206
        • Johns Hopkins University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

6 mois à 6 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation factorielle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Air Nicotine Levels
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
ETS Reduction, as Measured by Child's Cotinine Levels
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2009

Achèvement primaire (Réel)

1 janvier 2013

Achèvement de l'étude (Réel)

1 juin 2013

Dates d'inscription aux études

Première soumission

23 juin 2009

Première soumission répondant aux critères de contrôle qualité

23 juin 2009

Première publication (Estimation)

24 juin 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 août 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 août 2017

Dernière vérification

1 août 2017

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 664
  • R18HL092901-01 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

We will not be sharing individual participant data

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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