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CompletedNCT03536416MAISUpdated Nov 15, 2022

Self-management Intervention to Improve Adolescents' Asthma Control

An interventional study of My Asthma in School in Asthma, sponsored by Queen Mary University of London. Completed at 1 site in United Kingdom. Open to participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.

Sponsored by Queen Mary University of London · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
11 Years to 14 Years
Sex
All
01

Study summary

Approximately 1.1 million children and young people in the United Kingdom (UK) are living with asthma, making it the most common chronic disease in children in the UK. Our recent observational study found that poor asthma control, poor medication adherence, and a poor understanding of asthma were key unmet needs of secondary school children. Following the findings from an earlier study, the investigators have developed a preliminary theory-based multi-faceted intervention, aimed at improving asthma self-management and control in young people.

Read the detailed description

The investigators have developed a theory-driven self-management intervention for children and young people which addresses the barriers to successful self-management, which were identified in an earlier study. The intervention will engage asthmatic teenagers and their peers, and will be delivered in two components. The first component includes a theatre workshop for all children aged 11-13 years in London secondary schools. The aim of this component is to raise awareness of asthma in schools among peers. The second component is a series of four self-management workshops for children with asthma. The aim of this component is to teach children about asthma, using interactive role plays and games. The main topics will include asthma general knowledge and understanding; General Practitioner (GP) communication; asthma triggers and symptoms; medication and emergency response; and self-management techniques and goal setting. The children will also receive a toolkit to take home with them, which will include a copy of the workbook that they have used during the day, containing information on what they have learnt. There will also be information on where they can get more help for their asthma. The toolkit will also include information about a smartphone gaming app, which will be about asthma knowledge.

02

Conditions studied

  • Asthma

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Keywords

  • Self-management
  • Children and young people
  • Schools
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 330 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Doctor-diagnosed asthma
  • Aged 11-14 years (UK school years 7-8)
  • Attending the secondary school in which the study is implemented
  • All children in years 7 and 8 in UK secondary schools are eligible to watch the theatre performance

Exclusion criteria

Exclusion Criteria:

  • No diagnosis of asthma
  • Not aged 11-14 years (UK school years 7-8)
  • Not attending the school at the time the intervention is delivered
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
330 participants (actual)

Study arms

  • Experimental
    Asthma workshop and theatre group

    My Asthma in School. This group will receive the self-management workshops for asthmatic children and the theatre performance for the whole year group.

    Behavioral: My Asthma in School

  • Active comparator
    Theatre only group

    My Asthma in School. This group will receive the theatre performance only.

    Behavioral: My Asthma in School

  • No intervention
    Control group

    My Asthma in School. The control group will receive usual care for the duration of the intervention.

Interventions

  • BehavioralMy Asthma in School

    The intervention will include three arms. During the theatre workshop, the children will watch a theatre performance, and engage in a discussion at the end of the play, about what they have watched. The self-management workshops will cover a range of topics identified as barriers to self-management in our earlier study, and will be delivered to children with asthma only. The control group will receive usual care during the intervention.

06

What researchers measure

Primary outcomes

  1. Asthma control

    This will be measured using the validated Asthma Control Test. Scores range from 5-25. A score of 19 or below indicates poorly controlled asthma; a score of 20 or above indicates good asthma control.

    Time frame: 15 months

Secondary outcomes

  1. Medication Adherence Rating Scale.

    Measures medication adherence. This scale includes 10 questions. Compliance is indicated by a 'no' response to questions 1-6 and 9-10, and a 'yes' response for questions 7 and 8.

    Time frame: 15 months

  2. Unscheduled care

    This scale includes two multiple choice questions; one about unplanned doctor visits and one about unplanned hospital emergency department visits over the previous four weeks.

    Time frame: 15 months

  3. Brief-Illness Perception Questionnaire

    This scale includes 9 questions about perceptions of illness. Questions 3, 4 and 7 are reverse scored, and added to the scores for the remaining questions. A higher score indicates a more threatening view of the illness.

    Time frame: 15 months

  4. School absences

    This scale includes 3 multiple choice questions. These questions measure whole school day absences, lesson absences, and Physical Education lesson absences, over a four-week period.

    Time frame: 15 months

  5. Asthma knowledge

    This scale includes 14 questions about asthma knowledge.

    Time frame: 15 months

  6. Beliefs About Medicines Questionnaire

    This scale includes 10 statements about asthma medication. The participants indicate their agreement with the statement by selecting an option from strongly agree to strongly disagree.

    Time frame: 15 months

07

Study locations

1 site
  • Queen Mary University of London
    London, E1 2AT, United Kingdom
08

References and documents

Publications

  • Mosler G, Harris K, Grigg J, Steed L. Developing a theory-based multimedia intervention for schools to improve young people's asthma: my asthma in school (MAIS). Pilot Feasibility Stud. 2020 Sep 2;6:122. doi: 10.1186/s40814-020-00670-6. eCollection 2020. PubMed 32884832 ↗
  • Harris K, Mosler G, Grigg J. Theory-based self-management intervention to improve adolescents' asthma control: a cluster randomised controlled trial protocol. BMJ Open. 2019 Apr 23;9(4):e025867. doi: 10.1136/bmjopen-2018-025867. PubMed 31015270 ↗
  • Mosler G, Euba T. Taking control through drama. Lancet. 2018 Jan 27;391(10118):303-304. doi: 10.1016/S0140-6736(17)32283-3. Epub 2017 Sep 8. No abstract available. PubMed 29413036 ↗
  • Harris K, Newby C, Mosler G, Steed L, Griffiths C, Grigg J. School-based self-management intervention using theatre to improve asthma control in adolescents: a pilot cluster-randomised controlled trial. Pilot Feasibility Stud. 2022 Mar 23;8(1):67. doi: 10.1186/s40814-022-01031-1. PubMed 35321754 ↗

Related links

Individual participant data

Plan to share: No — Overall findings for each school will be reported back to individual schools, however individual participant data will not be reported due to data protection and confidentiality.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03536416
Lead sponsor
Queen Mary University of London
Responsible party
Jonathan Grigg (Professor, Queen Mary University of London) — Principal investigator
First posted
May 24, 2018
Start date
Dec 18, 2018
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Nov 15, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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