AsthmaPeerASMASNCT03446365
Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools
A study testing ASMAS and Asthma education plus child health in people with Asthma, run by Rhode Island Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- ASMAS and Asthma education plus child health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- daytime asthma symptoms > 2 days/week,
Show all 13Show fewer
- nighttime awakenings due to asthma at least 3-4 times/month,
- short-acting beta agonist use at least 2 days/week,
- activity limitation, or
- 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
Who cannot join
- active immunotherapy,
- other pulmonary disease,
- receiving special education services in a self-contained classroom,
- any severe psychiatric or medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- ASMAS, Asthma education plus child health
- Keywords
- Asthma, Latino children, middle school, peer models, educational intervention, high school students
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASMASBehavioural
A high school peer led group intervention for middles school students targeting asthma education and asthma management practices.
Asthma education plus child healthBehavioural
Health educator led intervention focused on asthma education and other child health topics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in asthma control
Assessed by child and parent report through the 7-item Child Asthma Control Test (C-ACT)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Child report through the valid and reliable Asthma Knowledge Questionnaire
Measured: 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.
Measured: 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
Measured: 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
Measured: Assessed at baseline, immediately post intervention, and 4 months post intervention , 8 months post intervention, and 12-months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Apr 2019
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico
- Responsible party
- Sponsor
- Investigators
- Daphne Koinis-Mitchell, PhD, Principal investigator, Rhode Island HospitalGlorisa Canino, PhD, Principal investigator, University of Puerto RicoSheryl J Kopel, MSc, Study director, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446365
- Sponsor's protocol ID
- 1R01MD012225-01
- Acronym
- PeerASMAS
- Status last verified
- Sep 2024
- First submitted
- 24 Jan 2018
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Administered Asthma Self-Management Intervention in Urban Middle Schools
- ClinicalTrials.gov ID
- NCT03446365
- Acronym / sponsor ID
- PeerASMAS / 1R01MD012225-01
- Conditions
- Asthma
- Keywords
- Asthma, Latino children, middle school, peer models, educational intervention, high school students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- University of Puerto Rico
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| ASMAS | Experimental | Behavioral: ASMASASMAS 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 | Active comparator | Behavioral: Asthma education plus child healthAsthma 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). |
| 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. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (4 listed)
- active immunotherapy,
- other pulmonary disease,
- receiving special education services in a self-contained classroom,
- any severe psychiatric or medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASMASA high school peer led group intervention for middles school students targeting asthma education and asthma management practices. | Behavioural | ASMAS |
| Asthma education plus child healthHealth educator led intervention focused on asthma education and other child health topics. | Behavioural | Asthma education plus child health |
Primary outcome
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)
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
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
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daphne Koinis-Mitchell, PhD principal investigator
Rhode Island Hospital
Glorisa Canino, PhD principal investigator
University of Puerto Rico
Sheryl J Kopel, MSc study director
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASMAS and Asthma education plus child health in people with Asthma, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.