Family Approach to Managing Asthma in Early Teens
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
BACKGROUND:
Asthma is a public health problem with its prevalence and morbidity being significant in 11- to 14-year olds, particularly among ethnic minorities. Despite this, little has been done to intervene with this age group. This is surprising considering the success of asthma education programs for younger children. In addition, there are no reports of parenting training to help families manage asthma despite the significant influence parenting strategies have on the management of chronic illnesses.
DESIGN NARRATIVE:
The overall goal of this study is to test the efficacy of a program with two complementary components: (a) a school-based curriculum to empower middle school students to manage their asthma and (b) a parent training curriculum to teach childrearing skills that support the youths' growing autonomy and need to self-manage their disease. The specific aims are: (1) to implement screening to identify 6th - 8th grade students with persistent asthma; and (2) to provide health education and parent training to help children and parents manage asthma more effectively. The student program is based on Coping with Asthma at Home and at School, a successful program developed in Holland. The parent program is an adaptation of Thriving Teens, an effective parent training program developed by the investigators. Participants in this randomized control trial will be 384 children with asthma and their caregivers from 16 New York City public schools serving low-income, ethnic minorities. It is hypothesized that students randomized to the intervention will have, relative to controls, improvements in three primary outcomes: (1) reduced symptom severity; (2) improved quality of life; and (3) better asthma management skills. Also, when compared to controls, intervention students will show improvement in the following secondary outcomes: (4) urgent health care utilization; (5) days with activity restriction; and (6) parent-child interactions. Caregivers and children will complete comprehensive surveys assessing these outcomes at baseline, and immediately and 6- and 12-months after the intervention.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10016
- New York University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria for Youth:
- Prior diagnosis of asthma from a medical provider
- Asthma symptoms an average of 3 times per month during the 12 months prior to study entry OR less frequent symptoms but having 1 or more urgent visits to a doctor/emergency room or hospitalization for asthma during the 12 months prior to study entry
- Use of prescribed asthma medication in the 12 months prior to study entry
Inclusion Criteria for Families:
- Child and participating parent must live together
Exclusion Criteria for Youth:
- Co-morbidity that might affect lung function, such as cystic fibrosis or sickle cell anemia
- Highly specialized developmental or learning needs (e.g., Down's syndrome, mental retardation, severe ADHD)
- Major psychiatric illness
Exclusion Criteria for Families:
- Foster parents and their children
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Behavioral Intervention: Asthma: It's a Family Affair
Separate student and parent intervention groups.
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Intervention families will receive a comprehensive program with two complementary components: (1) a school-based intervention to empower middle school students to manage their asthma and (2) parent training to teach their caregivers childrearing skills that support the youth's growing autonomy and need to self-manage their disease.
The student component is comprised of 6, 60 minute group workshops; the caregiver component consists of 5, 90-minute group workshops.
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Comparador activo: Behavioral Control Group
Students and parents participate in an education only control group
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Caregivers assigned to the Asthma and Stress Comparator group will receive a single educational workshop focusing on the developmental changes adolescents experience, how these changes may cause stress, and ways to cope with stress.
The children will also participate in a single school-based session on similar topics.
Both caregivers and students will learn basic asthma facts.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Symptom severity
Periodo de tiempo: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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quality of life
Periodo de tiempo: Baseline, and immediate, 6-months and 12-months post-intervention
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Baseline, and immediate, 6-months and 12-months post-intervention
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asthma management skills
Periodo de tiempo: Baseline, and immediate, 6-months and 12-months post-intervention
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Baseline, and immediate, 6-months and 12-months post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Urgent health care utilization
Periodo de tiempo: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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days with activity restriction
Periodo de tiempo: baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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baseline, immediate post-intervention and every 2 months thereafter up to and including 12-months post-intervention
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parent-child interactions
Periodo de tiempo: Baseline, and immediate, 6-months and 12-months post-intervention
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Baseline, and immediate, 6-months and 12-months post-intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jean-Marie Bruzzese, PhD, NYU Langone Health
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 333
- R01HL079953 (Subvención/contrato del NIH de EE. UU.)
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