NCT03446365Completed
Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools
Source: ClinicalTrials.gov · Last updated 27 Sept 2024
Brief summary (registry, in English)
Health disparities in pediatric asthma persist, with Latino children demonstrating increased asthma morbidity. Middle school children with asthma have greater morbidity than children from any other age group and spend a majority of their day in school, where they must manage any asthma. The investigators developed and piloted a novel group-based intervention - ASMAS (Asthma Self-MAnagement in Schools) in two geographic areas with a high prevalence of urban and Latino children with asthma: Providence, Rhode Island, and San Juan, Puerto Rico. ASMAS is a 4-session, peer-facilitated asthma self-management intervention specific to the school setting for Latino middle school (6th-8th graders) children. It is delivered by trained High School Juniors and Seniors of Latino descent with asthma. The preliminary effects of ASMAS for improving asthma outcomes and self-management relative to controls were demonstrated in a previous intervention development study. This study will evaluate ASMAS through a large-scaled Randomized Control Trial with urban middle school students who have persistent asthma in Providence, Rhode Island and San Juan, Puerto Rico and will identify barriers and facilitators to the implementation of ASMAS. These results will inform future, large-scale dissemination in other urban school settings.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 243 (actual)
- First submitted
- 24 Jan 2018
- Start date
- 1 Apr 2019
- Primary completion date
- 31 May 2024
- Lead sponsor
- Rhode Island Hospital
- Diseases
- Asthma
- NCT number
- NCT03446365
What you commit to
- Study type: Interventional
- Participants enrolled: 243
- From 1 Apr 2019 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- active immunotherapy,
- receiving special education services in a self-contained classroom,
Other illness
- other pulmonary disease,
- any severe psychiatric or medical conditions
Who the study is looking for
- Be 11-14 years old
- Attend 6th, 7th or 8th grade
- attend a targeted public school
- have physician-diagnosed asthma according to caregiver and provider report
- meet criteria for current persistent asthma either by a) having a current prescription for an asthma controller medicine, or b) having any of the following in the previous 4 weeks:
- daytime asthma symptoms \> 2 days/week,
- nighttime awakenings due to asthma at least 3-4 times/month,
- short-acting beta agonist use at least 2 days/week,
- activity limitation, or
- oral steroid use at least 2 times/year
- children must have recent active asthma activity in the previous 4 weeks through endorsement of any of criteria I-V above
- In Rhode Island, children's primary caregiver must identify as Latino
- In Rhode Island, children must speak English
Age in the registry: 11 years to 14 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.