ASPIREProject ASPIRE: Improving Pediatric Asthma Management for Urban Families
Project ASPIRE Home-Based Family Intervention
+ Project ASPIRE Enhanced Treatment As Usual
Asthme+6
+ Maladies bronchiques
+ Hypersensibilité
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 2007
Date à laquelle le premier participant a commencé l'étude.Asthma is a serious, chronic illness that affects 9 million children in the United States. Common asthma symptoms include wheezing, shortness of breath, chest tightness, and coughing. Asthma attacks can be triggered by a variety of irritants, including mold, pollen, tobacco smoke, or allergies. Stress can also cause asthma attacks, and children who experience high levels of stress and anxiety tend to have poor asthma management skills and health outcomes. Additionally, family stress can affect the ability of families and caregivers to provide adequate care to children with asthma. Currently, few asthma education programs are aimed at helping both children and parents manage stress. The purpose of this study is to evaluate the effectiveness of a stress-reduction family intervention on improving health outcomes in asthmatic children. Study researchers will first conduct focus groups with children who have asthma, their parents, and community health organizations to identify barriers to effective asthma management and sources of stress for caregivers; a family-focused intervention will then be developed. Fifty families with an asthmatic child will be enrolled and randomly assigned to one of two groups. Group 1 participants will partake in four to six home-based, family educational sessions over a 4-month period. Sessions will focus on asthma education and stress management techniques for the entire family. One of these sessions may take place at the child's doctor's office as a way to focus on improving parent-doctor communication. Group 2 participants will partake in a single home-based asthma education session. Study visits for all participants will occur at baseline, Month 4, and 6 months post-intervention. At these timepoints, asthma self-management will be assessed through family interviews and observation of the child's inhaler use; tobacco exposure levels will be measured with a urine test; and family functioning and stress levels will be assessed with questionnaires.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.43 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 8 à 13 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 2 sites
Emory University School of Medicine
Atlanta, United StatesOuvrir Emory University School of Medicine dans Google MapsAmerican Lung Association - Southeast Division
Smyrna, United States