School-based Asthma Therapy: Stage 2 Effectiveness Study (SBAT)

University of Rochester

Status: Completed

Conditions: Asthma

Treatments: Behavioral: School-based Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01175369

12308

1R01HL079954-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.

Enrollment: 530 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physician-diagnosed asthma
• Mild persistent to severe persistent asthma
• Ages 3-10 years
• Attending school in the Rochester City School District preschools or elementary schools
• Signed physician permission to enroll the child
• Parent or caregiver must consent to the intervention

Exclusion criteria

• Inability to speak and understand either English or Spanish
• No access to a working phone for follow-up surveys
• The family planning to leave the school district within fewer than 6 months
• The child having other significant medical conditions that could interfere with the assessment of asthma-related outcome measures
• children in foster care or other situations in which consent cannot be obtained from a guardian
• Current participation in other local asthma interventions

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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530 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Usual asthma care

School-based Care

Experimental group

Description:

The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).

Treatment:

Behavioral: School-based Care