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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASMAS
Asthma education plus child health
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Asthma, Latino children, middle school, peer models, educational intervention, high school students

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rhode Island HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

ASMAS

Asthma education plus child health

No Treatment Control

Arm Description

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.

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).

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

Outcomes

Primary Outcome Measures

Change in asthma control
Assessed by child and parent report through the 7-item Child Asthma Control Test (C-ACT)
Change in symptom free days
By parent report using standard questionnaire of symptom-free days/nights in prior 30 days
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
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.

Secondary Outcome Measures

Change in child asthma knowledge
Child report through the valid and reliable Asthma Knowledge Questionnaire
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.
Change in asthma self-management
Through a well-validated and reliable measure; child and caregiver versions
Change in asthma Action plan/Inhaler availability
School Nurse report of Availability of rescue inhaler at school and asthma action plan with school nurse

Full Information

First Posted
January 24, 2018
Last Updated
October 21, 2020
Sponsor
Rhode Island Hospital
Collaborators
University of Puerto Rico
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1. Study Identification

Unique Protocol Identification Number
NCT03446365
Brief Title
Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools
Acronym
PeerASMAS
Official Title
Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
Collaborators
University of Puerto Rico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Latino children, middle school, peer models, educational intervention, high school students

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASMAS
Arm Type
Experimental
Arm Description
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.
Arm Title
Asthma education plus child health
Arm Type
Active Comparator
Arm Description
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).
Arm Title
No Treatment Control
Arm Type
No Intervention
Arm Description
Students randomly assigned to this arm , will receive standard of care, which is no treatment, and will not participate in any group intervention sessions.
Intervention Type
Behavioral
Intervention Name(s)
ASMAS
Intervention Description
A high school peer led group intervention for middles school students targeting asthma education and asthma management practices.
Intervention Type
Behavioral
Intervention Name(s)
Asthma education plus child health
Intervention Description
Health educator led intervention focused on asthma education and other child health topics.
Primary Outcome Measure Information:
Title
Change in asthma control
Description
Assessed by child and parent report through the 7-item Child Asthma Control Test (C-ACT)
Time Frame
Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Title
Change in symptom free days
Description
By parent report using standard questionnaire of symptom-free days/nights in prior 30 days
Time Frame
Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Title
Change in asthma related school absence ratio
Description
Asthma related school absence ratio will be calculated from school attendance data and caregiver report of school absences due to asthma
Time Frame
Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Title
Change in lung function
Description
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.
Time Frame
Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Secondary Outcome Measure Information:
Title
Change in child asthma knowledge
Description
Child report through the valid and reliable Asthma Knowledge Questionnaire
Time Frame
Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Title
Change in child asthma self-efficacy
Description
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.
Time Frame
Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Title
Change in asthma self-management
Description
Through a well-validated and reliable measure; child and caregiver versions
Time Frame
Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Title
Change in asthma Action plan/Inhaler availability
Description
School Nurse report of Availability of rescue inhaler at school and asthma action plan with school nurse
Time Frame
Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daphne Koinis-Mitchell, PhD
Phone
(401) 793-3682
Email
dkoinismitchell@lifespan.org
First Name & Middle Initial & Last Name or Official Title & Degree
Maria T Coutinho, PhD
Phone
(401) 793-8860
Email
mcoutinho@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne Koinis-Mitchell, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glorisa Canino, PhD
Organizational Affiliation
University of Puerto Rico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria T Coutinho, PhD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daphne Koinis-Mitchell, PhD
Phone
401-793-3682
Email
dkoinismitchell@lifespan.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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