Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools (PeerASMAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Behavioral: ASMAS; Behavioral: Asthma education plus child health

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.

• Study Type: Interventional
• Enrollment (Anticipated): 432
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daphne Koinis-Mitchell, PhD; Phone Number: (401) 793-3682; Email: dkoinismitchell@lifespan.org
• Study Contact Backup: Name: Maria T Coutinho, PhD; Phone Number: (401) 793-8860; Email: mcoutinho@lifespan.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
      • Contact: daphne Koinis-Mitchell, PhD; Phone Number: 401-793-3682; Email: dkoinismitchell@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria specify that students must:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: ASMAS; A high school peer led group intervention for middles school students targeting asthma education and asthma management practices.
Active Comparator: 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).	Behavioral: Asthma education plus child health; Health educator led intervention focused on asthma education and other child health topics.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in child asthma knowledge	Child report through the valid and reliable Asthma Knowledge Questionnaire	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	Child report through valid and reliable children's Asthma Self-Efficacy Scale (Cronbach alpha .87; Bursch, et al, 1999). The scale includes 14 items with responses ranging from 1 to 6, and higher scores indicate more self-efficacy to care for asthma. An asthma self-efficacy score is calculated using the average of the 14 items.	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	Through a well-validated and reliable measure; child and caregiver versions	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	School Nurse report of Availability of rescue inhaler at school and asthma action plan with school nurse	Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: University of Puerto Rico
• Investigators: Principal Investigator: Daphne Koinis-Mitchell, PhD, Rhode Island Hospital; Study Director: Maria T Coutinho, PhD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): August 15, 2023

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Asthma; middle school; educational intervention; high school students; Latino children; peer models
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 1R01MD012225-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No