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

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ClinicalTrials.gov Identifier: NCT03446365
Recruitment Status : Not yet recruiting
First Posted : February 26, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
University of Puerto Rico
Information provided by (Responsible Party):
Rhode Island Hospital

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: ASMAS Behavioral: Asthma education plus child health Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Change in asthma control [ Time Frame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention ]
    Assessed by child and parent report through the 7-item Child Asthma Control Test (C-ACT)

  2. Change in symptom free days [ Time Frame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention ]
    By parent report using standard questionnaire of symptom-free days/nights in prior 30 days

  3. Change in asthma related school absence ratio [ Time Frame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention ]
    Asthma related school absence ratio will be calculated from school attendance data and caregiver report of school absences due to asthma

  4. Change in lung function [ Time Frame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention ]
    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.


Secondary Outcome Measures :
  1. Change in child asthma knowledge [ Time Frame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention ]
    Child report through the valid and reliable Asthma Knowledge Questionnaire

  2. Change in child asthma self-efficacy [ Time Frame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention ]
    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.

  3. Change in asthma self-management [ Time Frame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention ]
    Through a well-validated and reliable measure; child and caregiver versions

  4. Change in asthma Action plan/Inhaler availability [ Time Frame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention ]
    School Nurse report of Availability of rescue inhaler at school and asthma action plan with school nurse



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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446365


Contacts
Contact: Daphne Koinis-Mitchell, PhD (401) 793-3682 dkoinismitchell@lifespan.org
Contact: Maria T Coutinho, PhD (401) 793-8860 mcoutinho@lifespan.org

Sponsors and Collaborators
Rhode Island Hospital
University of Puerto Rico
Investigators
Principal Investigator: Daphne Koinis-Mitchell, PhD Rhode Island Hospital
Principal Investigator: Glorisa Canino, PhD University of Puerto Rico
Study Director: Maria T Coutinho, PhD Rhode Island Hospital

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03446365     History of Changes
Other Study ID Numbers: 1R01MD012225-01 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rhode Island Hospital:
Asthma
Latino children
middle school
peer models
educational intervention
high school students

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases