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

NCT03446365 | Completed DMC

• 1 other identifier: 1R01MD012225-01
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Latino children; middle school; peer models; educational intervention; high school students

Outcome Measures

Primary Outcomes (4)

• Change in asthma control

  Assessed by child and parent report through the 7-item Child Asthma Control Test (C-ACT)

  Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

• Change in symptom free days

  By parent report using standard questionnaire of symptom-free days/nights in prior 30 days

  Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

• Change in asthma related school absence ratio

  Asthma related school absence ratio will be calculated from school attendance data and caregiver report of school absences due to asthma

  Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

• Change in lung function

  The Asthma Monitor 2 (AM2, ERT, USA) is a hand-held, computerized spirometer that collects pulmonary function indexes (Forced Expiratory Volume at one second, FEV1 ). Children will use AM2 during one week using standard procedures, 2x/day (before medications AM/PM). FEV1 predicted will be obtained.

  Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

Secondary Outcomes (4)

• Change in child asthma knowledge

  Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

• Change in child asthma self-efficacy

  Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

• Change in asthma self-management

  Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

• Change in asthma Action plan/Inhaler availability

  Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

Study Arms (3)

ASMAS

EXPERIMENTAL

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.

Behavioral: ASMAS

Asthma education plus child health

ACTIVE COMPARATOR

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).

Behavioral: Asthma education plus child health

No Treatment Control

NO INTERVENTION

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

Interventions

ASMAS BEHAVIORAL

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

ASMAS

Asthma education plus child health BEHAVIORAL

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

Asthma education plus child health

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• University of Puerto Rico: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Child Health

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Officials

• Daphne Koinis-Mitchell, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Glorisa Canino, PhD

  University of Puerto Rico

  PRINCIPAL INVESTIGATOR

• Sheryl J Kopel, MSc

  Rhode Island Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 6th to 8th grade middle schoolers will be enrolled then randomly assigned to one of three conditions: 1) ASMAS, 6th to 8th grade middle schoolers will be enrolled then randomly assigned to 1) ASMAS, or 2) Asthma Education plus Child Health control condition, or 3) a no treatment control condition

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 26, 2018
• Study Start: April 1, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)