Clinical trial NCT03446365: Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools
Official title: Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Latino children
middle school
peer models
educational intervention
high school students
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
First posted: 2018-02-26
Enrollment: 243
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in asthma control
timeFrame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
measure: Change in symptom free days
timeFrame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
measure: Change in asthma related school absence ratio
timeFrame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
measure: Change in lung function
timeFrame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Secondary outcomes:
measure: Change in child asthma knowledge
timeFrame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
measure: Change in child asthma self-efficacy
timeFrame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
measure: Change in asthma self-management
timeFrame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
measure: Change in asthma Action plan/Inhaler availability
timeFrame: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Daphne Koinis-Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Puerto Rico
name: Glorisa Canino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Sheryl J Kopel, MSc
role: STUDY_DIRECTOR
References: