Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools

NCT ID: NCT03446365

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2024-05-31

Brief Summary

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.

Detailed Description

The goal of this study is to evaluate a 4-session, peer-facilitated asthma self-management intervention for Latino, middle school (6th-8th) youth in urban public school settings. The intervention, ASMAS (Asthma Self-Management in Schools) is administered by trained and supervised High School juniors and seniors of Latino descent with asthma to middle school peers with asthma. This study is a partnership with a second research group in San Juan, Puerto Rico, since there is also a high rate of asthma in children there.

There are 2 goals in this study. The first goal is to evaluate the effects of ASMAS on asthma health outcomes (for example, asthma control, symptom free days, school absences and lung function) and on asthma self-management (skills, knowledge and self-efficacy, availability of rescue inhaler and action plan at school) in a sample of 432 Latino middle school children with asthma in Providence, Rhode Island and San Juan, Puerto Rico.

Middle schoolers and a primary caregiver will complete a baseline research session, as well as, immediately post intervention and 4-month, 8-month and 12-month post intervention follow-up research home visits during which they will complete study questionnaires about the child's asthma. Students will be randomly assigned to one of three study groups. Assignment is random (like a coin toss), and what each student does in school depends on what group each student is assigned to. The ASMAS group and the Asthma + Health Education groups will learn about asthma and about other selected health topics during their in-school intervention sessions (1 per week for 4 weeks). The "no treatment" study group will not attend in-school group sessions at all.

The second goal in the study is to evaluate the intervention in preparation for using it on a wider scale in other places. Students, caregivers, High School Peers, school administrators and additional community members will be invited to participate in group discussions about the intervention.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ASMAS

ASMAS is an asthma self-management program based on NHLBI clinical guidelines for optimal school-based asthma management. It involves 4, 1½ hour sessions delivered in group format in the urban, middle school setting by a Latino High School Peer who has asthma. ASMAS focuses on asthma pathophysiology, symptom management, asthma medications, and trigger control.

Group Type: EXPERIMENTAL

ASMAS

Intervention Type: BEHAVIORAL

A high school peer led group intervention for middles school students targeting asthma education and asthma management practices.

Asthma education plus child health

Asthma Education plus Child Health control condition will be delivered by an adult Health Educator , and includes 4 sessions (1 1/2 hrs long) of our existing asthma education ("Asthma's Magic Number") with added general health topics (nutrition, physical activity, safety).

Group Type: ACTIVE_COMPARATOR

Asthma education plus child health

Intervention Type: BEHAVIORAL

Health educator led intervention focused on asthma education and other child health topics.

No Treatment Control

Students randomly assigned to this arm , will receive standard of care, which is no treatment, and will not participate in any group intervention sessions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ASMAS

A high school peer led group intervention for middles school students targeting asthma education and asthma management practices.

Intervention Type: BEHAVIORAL

Asthma education plus child health

Health educator led intervention focused on asthma education and other child health topics.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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:

I. daytime asthma symptoms > 2 days/week,

II. nighttime awakenings due to asthma at least 3-4 times/month,

III. short-acting beta agonist use at least 2 days/week,

IV. activity limitation, or

V. 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

Exclusion Criteria

• active immunotherapy,
• other pulmonary disease,
• receiving special education services in a self-contained classroom,
• any severe psychiatric or medical conditions

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daphne Koinis-Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Glorisa Canino, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Puerto Rico

Sheryl J Kopel, MSc

Role: STUDY_DIRECTOR

Rhode Island Hospital

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

1R01MD012225-01

Identifier Type: NIH

Identifier Source: org_study_id

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