Asthma in ChildrenIMPAQTNCT06851715
Improving Quality of Life for Teenagers With Asthma
A study testing Clinic consultation focused on asthma self-management in people with Asthma in Children and Asthma, run by University Hospital Southampton NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
BACKGROUND: Asthma is a long-term lung condition affecting 1 in 11 children and young people in the UK. Many teenagers have well controlled asthma, but a significant number continue to experience regular symptoms and asthma attacks leading to hospitalisations. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Asthma in Children, Asthma
- What is being tested?
- Clinic consultation focused on asthma self-management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 26 Aug 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent aged 12-18 years
- Attending a paediatric respiratory clinic
- Informed consent from adolescent aged ≥16 years, and assent plus parent/guardian consent for adolescents aged ≤16 years
- Paediatric Asthma Quality of Life Questionnaire score ≤5.5 points
Who cannot join
- Aged 0-11 or over 18 years
- Other significant long-term medical condition that has a day-to-day impact on their lives (except for co-existing allergic conditions, breathing pattern disorder, dysfunctional breathing, or intermittent laryngeal obstruction)
- Adolescent or parent/guardian unable to communicate sufficiently to complete consent forms.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Isle of Wight NHS Trust, St Mary's Hospital
Isle of Wight, Isle of Wight, PO30 5TG
Graham Roberts, +44 (0)23 8059 8138, g.c.roberts@soton.ac.uk
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6Y
Graham Roberts, +44 (0)23 8059 8138, g.c.roberts@soton.ac.uk
About this study
Official title: Can the Quality of Life of Adolescents With Asthma be Improved by Focusing on Improving Their Asthma Self-management
BACKGROUND: Asthma is a long-term lung condition affecting 1 in 11 children and young people in the UK. Many teenagers have well controlled asthma, but a significant number continue to experience regular symptoms and asthma attacks leading to hospitalisations. While non-adherence to medication is a factor, teenagers also face challenges like changing relationships with parents and peers, avoiding triggers like smoking, and fitting in treatment with daily life demands. Healthcare professionals (HCPs) also face difficulties in managing teenagers with asthma.
A previous study, funded by Asthma + Lung UK, developed a new approach to manage teenage asthma by focusing on self-efficacy, which is how confident one feels about performing a task. Teenagers completed the Adolescent Asthma Self-Efficacy Questionnaire (AASEQ), which identified areas where they needed more support. HCPs then tailored their consultations to address these needs. This approach improved the teenagers' confidence in self-managing their asthma.
Read more
Improving quality of life (QoL) is a key goal in asthma care. Therefore, the aim of this study is to determine if the self-efficacy approach improves QoL for teenagers with asthma.
METHODS: Teenagers aged 12-18 years with asthma will be recruited from hospital clinics. They will be randomly assigned to one of two groups:
- Teenager will complete the AASEQ at the start of their appointment. The HCPs will use this to focus the consultation on areas where the teenager needs support in self-managing their asthma.
- Teenager will have their usual consultation with the HCP.
Three months after the appointment, the QoL will be compared between the two groups using a standardised questionnaire.
IMPACT: If the self-efficacy approach proves to be beneficial, it could help HCPs to empower teenagers to better manage their asthma and ultimately improve their quality of life.
- Conditions
- Asthma in Children, Asthma
- Being tested
- Clinic consultation focused on asthma self-management
- Keywords
- Asthma, Adolescent, Self-efficacy, Quality of life, Asthma control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic consultation focused on asthma self-managementOther
The clinic healthcare professionals (HCPs) will be provided with the completed Adolescent Asthma Self-efficacy Questionnaire (AASEQ), which will help identify areas where participants need additional support to improve their asthma self-management skills. Targeted behavioural interventions, developed during the 'ItsMyAsthma' study, will be applied during the clinic consultation to address individual needs.
| Study group | Role | What they receive |
|---|---|---|
| Clinic consultation focused on asthma self-management | Experimental | The participant will complete the Adolescent Asthma Self-efficacy Questionnaire (AASEQ), and the clinic healthcare professional will use the responses to focus the consultation on areas where the participant needs support for asthma self-management. Receives: Other: Clinic consultation focused on asthma self-management |
| Usual clinic consultation | No intervention | The participant will not complete the AASEQ at baseline and their healthcare professional will conduct the consultation as per usual management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
Paediatric Asthma Quality of Life Questionnaire score ranging from 0-36 points, with a higher score indicating worse quality of life.
Measured: 3 months after enrolment
Secondary outcomes (3)
Asthma-related healthcare utilisation
Asthma-related healthcare utilisation including number of asthma exacerbations requiring prednisolone/dexamethasone, and/or GP visits, Emergency Department, Hospital, or Intensive care admissions.
Measured: 3 months after enrolment
Asthma Control Test (ACT)
Asthma Control Test score ranging from 5-25 points, with a higher score indicating better asthma control.
Measured: 3 months after enrolment
Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)
Adolescent Asthma Self Efficacy Questionnaire score ranging from 0-100 points, with a higher score indicating greater self-efficacy for management of asthma.
Measured: 3 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start26 Aug 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Rattu, Study director, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851715
- Sponsor's protocol ID
- RHM CHI1258
- Other IDs
- 349662
- Acronym
- IMPAQT
- Status last verified
- Dec 2025
- First submitted
- 24 Feb 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please contact the study investigators to request trial data. Note that it will need to be anonymised before sharing.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Quality of Life of Adolescents With Asthma be Improved by Focusing on Improving Their Asthma Self-management
- ClinicalTrials.gov ID
- NCT06851715
- Acronym / sponsor ID
- IMPAQT / RHM CHI1258
- Conditions
- Asthma in Children, Asthma
- Keywords
- Asthma, Adolescent, Self-efficacy, Quality of life, Asthma control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 28 Feb 2025 (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.
BACKGROUND: Asthma is a long-term lung condition affecting 1 in 11 children and young people in the UK. Many teenagers have well controlled asthma, but a significant number continue to experience regular symptoms and asthma attacks leading to hospitalisations. While non-adherence to medication is a factor, teenagers also face challenges like changing relationships with parents and peers, avoiding triggers like smoking, and fitting in treatment with daily life demands. Healthcare professionals (HCPs) also face difficulties in managing teenagers with asthma.
A previous study, funded by Asthma + Lung UK, developed a new approach to manage teenage asthma by focusing on self-efficacy, which is how confident one feels about performing a task. Teenagers completed the Adolescent Asthma Self-Efficacy Questionnaire (AASEQ), which identified areas where they needed more support. HCPs then tailored their consultations to address these needs. This approach improved the teenagers' confidence in self-managing their asthma.
Improving quality of life (QoL) is a key goal in asthma care. Therefore, the aim of this study is to determine if the self-efficacy approach improves QoL for teenagers with asthma.
METHODS: Teenagers aged 12-18 years with asthma will be recruited from hospital clinics. They will be randomly assigned to one of two groups:
- Teenager will complete the AASEQ at the start of their appointment. The HCPs will use this to focus the consultation on areas where the teenager needs support in self-managing their asthma.
- Teenager will have their usual consultation with the HCP.
Three months after the appointment, the QoL will be compared between the two groups using a standardised questionnaire.
IMPACT: If the self-efficacy approach proves to be beneficial, it could help HCPs to empower teenagers to better manage their asthma and ultimately improve their quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic consultation focused on asthma self-management | Experimental | Other: Clinic consultation focused on asthma self-managementThe participant will complete the Adolescent Asthma Self-efficacy Questionnaire (AASEQ), and the clinic healthcare professional will use the responses to focus the consultation on areas where the participant needs support for asthma self-management. |
| Usual clinic consultation | No intervention | –The participant will not complete the AASEQ at baseline and their healthcare professional will conduct the consultation as per usual management. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescent aged 12-18 years
- Attending a paediatric respiratory clinic
- Informed consent from adolescent aged ≥16 years, and assent plus parent/guardian consent for adolescents aged ≤16 years
- Paediatric Asthma Quality of Life Questionnaire score ≤5.5 points
Key exclusion criteria (3 listed)
- Aged 0-11 or over 18 years
- Other significant long-term medical condition that has a day-to-day impact on their lives (except for co-existing allergic conditions, breathing pattern disorder, dysfunctional breathing, or intermittent laryngeal obstruction)
- Adolescent or parent/guardian unable to communicate sufficiently to complete consent forms.
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 |
|---|---|---|
| Clinic consultation focused on asthma self-managementThe clinic healthcare professionals (HCPs) will be provided with the completed Adolescent Asthma Self-efficacy Questionnaire (AASEQ), which will help identify areas where participants need additional support to improve their asthma self-management skills. Targeted behavioural interventions, developed during the 'ItsMyAsthma' study, will be applied during the clinic consultation to address individual needs. | Other | Clinic consultation focused on asthma self-management |
Primary outcome
Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time frame: 3 months after enrolment
Paediatric Asthma Quality of Life Questionnaire score ranging from 0-36 points, with a higher score indicating worse quality of life.
3 secondary outcomes
Asthma-related healthcare utilisation
Time frame: 3 months after enrolment
Asthma Control Test (ACT)
Time frame: 3 months after enrolment
Adolescent Asthma Self-Efficacy Questionnaire (AASEQ)
Time frame: 3 months after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Yes. Please contact the study investigators to request trial data. Note that it will need to be anonymised before sharing.
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
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.
Anna Rattu study director
University of Southampton
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinic consultation focused on asthma self-management in people with Asthma in Children and Asthma, run by University Hospital Southampton NHS Foundation Trust at 2 sites in United Kingdom.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Rattu (+44 (0)23 8059 6835, a.s.rattu@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paediatric Asthma Quality of Life Questionnaire (PAQLQ) (time frame: 3 months after enrolment). 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 5 Jan 2026.