Child AllergyNCT06221540
The Impact of an Evidence-based Myth-busting Information Intervention on Maternal Food Allergy Related Quality of Life, Anxiety and Self-efficacy
A study testing "Myth busting" information leaflet in people with Child Allergy and Food Allergy, run by Children's Health Ireland at 1 site in Ireland.
Trial summary
Children with Food Allergy (FA) are at risk of life threatening reactions. They must carry an emergency medicine kit containing adrenaline auto-injector devices for the immediate treatment of anaphylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Allergy, Food Allergy
- What is being tested?
- "Myth busting" information leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteIreland
- Study dates
- 21 May 2021to 30 Jun 2021
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First referral to Children's Health Ireland allergy service for evaluation of 'Immediate type' IgE food allergy.
- Referral accepted and triaged to a waiting list between 30 months to six months prior to study commencement.
- Child aged between three years and 12 years at the time of study commencement.
Who cannot join
- Referral source from Children's Health Ireland (CHI) dermatology or immunology services or the patient already attends services that will evaluate food allergy such as CHI dermatology and /or immunology.
- Child younger than three years and older than 12 years at the time of study commencement.
- Referral information is not suggestive of an IgE mediated food allergy.
- Complex referral history suggestive of chronic urticaria, mast cell disorders or eosinophilic oesophagitis.
Trial locations and contacts
1 site in 1 country.
About this study
Children with Food Allergy (FA) are at risk of life threatening reactions. They must carry an emergency medicine kit containing adrenaline auto-injector devices for the immediate treatment of anaphylaxis.
Much research has documented the adverse impact of childhood FA on the food allergy related quality of life (FQoL) of the Carer and the family, along with reported higher levels of anxiety and stress. These adverse impacts are largely driven by the need for Carers to always be "emergency ready". Mothers of food allergic children report higher levels of anxiety compared to the rest of the family, possibly due to mothers commonly being the primary care givers responsible for the preparation of meals, childcare etc.
Read more
Carers of newly diagnosed food allergic children, looking for more information about their child's FA are at risk of exposure to myths and misinformation about food allergy. These falsehoods are likely to increase further, Carers Food Allergy-related anxiety.
The investigators wish to survey the frequency with which common myths on FA are believed among mothers prior to their attendance at an allergy clinic. They wish to understand the impact of "myth-busting" information on maternal anxiety or self-efficacy when provided to mothers while awaiting a specialist appointment.
The research question is to determine if the online educational session is effective at decreasing anxiety and improving quality of life in Carers of FA children awaiting a specialist appointment.
Read the detailed description
Carers of food allergic children report that their information needs are greatest at the beginning of their journey when their child first experiences a food allergic reaction. Unfortunately, wait times to attend specialist paediatric allergy clinics can be lengthy. Thus, families can experience a prolonged time-gap between the initial allergic reaction and accessing diagnostic testing and benefitting from multi-disciplinary support and education. Furthermore, carers report often contradictory advice from non-specialist Healthcare Professionals (HCPs). This in turn encourages carers to look for information online with many using search engines unless guided to official food allergy websites by HCPs. Not all online information is correct, or evidence based. Often information provided suggests that certain FA children are at greater risk of anaphylaxis and mortality. This in turn increases anxiety amongst carers and impairs their quality of life.
The purpose of this study is to develop an effective intervention that improves maternal FA related quality of life, anxiety, and self-efficacy prior to attending their child's first paediatric allergy clinic appointment. A randomized control trial will be performed comparing quality of life, anxiety and self efficacy in carers who receive the intervention versus those that do not. Participants will be randomized into 2 groups. All volunteers, from both groups, will complete questionnaires online using only a study identifier number. This will ensure anonymity throughout the study. The only personal information that will be asked is the carer's age group, whether they are a mother or father, their child's age and gender and whether they have any other allergies. Group 1 will be sent a written patient information leaflet displaying ten food allergy myths with the myth-busting evidence-based information clearly stated. Two weeks following the online educational session, Groups 1 and 2 will again complete the online questionnaires.
The outcomes are health related quality of life and levels of anxiety. It is hoped that the findings will positively support Carers, children and their families
- Conditions
- Child Allergy, Food Allergy
- Being tested
- "Myth busting" information leaflet
- Keywords
- Educational intervention, Food Allergy, Quality of Life, Anxiety, Self efficacy, Maternal education, Booklet, Immune System Diseases, Hypersensitivity, Immediate, Food Hypersensitivity
- Medical subject headings
- Food Hypersensitivity, Anxiety Disorders, Immune System Diseases, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Myth busting" information leafletBehavioural
A written patient information leaflet displaying ten food allergy myths with the myth-busting evidence-based information clearly stated, focusing on themes pertinent to the myth-busting information
| Study group | Role | What they receive |
|---|---|---|
| Received written patient information leaflet | Experimental | Not described Receives: Behavioral: "Myth busting" information leaflet |
| Routine education at first clinic appointment | No intervention | Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1
Change in score in each group on Food Allergy Quality of Life Questionnaire (FAQLQ)-Parental Proxy Form
Measured: 2 weeks
Primary Outcome 2
Change in score in each group on Food Allergy Independent Measurement (FAIM)
Measured: 2 weeks
Primary Outcome 3
Change in score in each group on Food Allergy Anxiety Scale (FAAS)
Measured: 2 weeks
Secondary outcomes (1)
Secondary score
Agreement with Food Allergy Myths measured using the Food Allergy Belief (FAB) scale (SEFAQ)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start21 May 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AllergyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Health Ireland
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aideen Byrne, PhD, Principal investigator, Children's Health Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221540
- Sponsor's protocol ID
- GEN/894/21
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Evidence-based Myth-busting Information Intervention on Maternal Food Allergy Related Quality of Life, Anxiety and Self-efficacy
- ClinicalTrials.gov ID
- NCT06221540
- Acronym / sponsor ID
- GEN/894/21
- Conditions
- Child Allergy, Food Allergy
- Keywords
- Educational intervention, Food Allergy, Quality of Life, Anxiety, Self efficacy, Maternal education, Booklet, Immune System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Children's Health IrelandOther government
- Study start
- 21 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 24 Jan 2024 (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.
Children with Food Allergy (FA) are at risk of life threatening reactions. They must carry an emergency medicine kit containing adrenaline auto-injector devices for the immediate treatment of anaphylaxis.
Much research has documented the adverse impact of childhood FA on the food allergy related quality of life (FQoL) of the Carer and the family, along with reported higher levels of anxiety and stress. These adverse impacts are largely driven by the need for Carers to always be "emergency ready". Mothers of food allergic children report higher levels of anxiety compared to the rest of the family, possibly due to mothers commonly being the primary care givers responsible for the preparation of meals, childcare etc.
Carers of newly diagnosed food allergic children, looking for more information about their child's FA are at risk of exposure to myths and misinformation about food allergy. These falsehoods are likely to increase further, Carers Food Allergy-related anxiety.
The investigators wish to survey the frequency with which common myths on FA are believed among mothers prior to their attendance at an allergy clinic. They wish to understand the impact of "myth-busting" information on maternal anxiety or self-efficacy when provided to mothers while awaiting a specialist appointment.
The research question is to determine if the online educational session is effective at decreasing anxiety and improving quality of life in Carers of FA children awaiting a specialist appointment.
Detailed description
Carers of food allergic children report that their information needs are greatest at the beginning of their journey when their child first experiences a food allergic reaction. Unfortunately, wait times to attend specialist paediatric allergy clinics can be lengthy. Thus, families can experience a prolonged time-gap between the initial allergic reaction and accessing diagnostic testing and benefitting from multi-disciplinary support and education. Furthermore, carers report often contradictory advice from non-specialist Healthcare Professionals (HCPs). This in turn encourages carers to look for information online with many using search engines unless guided to official food allergy websites by HCPs. Not all online information is correct, or evidence based. Often information provided suggests that certain FA children are at greater risk of anaphylaxis and mortality. This in turn increases anxiety amongst carers and impairs their quality of life.
The purpose of this study is to develop an effective intervention that improves maternal FA related quality of life, anxiety, and self-efficacy prior to attending their child's first paediatric allergy clinic appointment. A randomized control trial will be performed comparing quality of life, anxiety and self efficacy in carers who receive the intervention versus those that do not. Participants will be randomized into 2 groups. All volunteers, from both groups, will complete questionnaires online using only a study identifier number. This will ensure anonymity throughout the study. The only personal information that will be asked is the carer's age group, whether they are a mother or father, their child's age and gender and whether they have any other allergies. Group 1 will be sent a written patient information leaflet displaying ten food allergy myths with the myth-busting evidence-based information clearly stated. Two weeks following the online educational session, Groups 1 and 2 will again complete the online questionnaires.
The outcomes are health related quality of life and levels of anxiety. It is hoped that the findings will positively support Carers, children and their families
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received written patient information leaflet | Experimental | Behavioral: "Myth busting" information leaflet |
| Routine education at first clinic appointment | No intervention | –Active Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First referral to Children's Health Ireland allergy service for evaluation of 'Immediate type' IgE food allergy.
- Referral accepted and triaged to a waiting list between 30 months to six months prior to study commencement.
- Child aged between three years and 12 years at the time of study commencement.
Key exclusion criteria (4 listed)
- Referral source from Children's Health Ireland (CHI) dermatology or immunology services or the patient already attends services that will evaluate food allergy such as CHI dermatology and /or immunology.
- Child younger than three years and older than 12 years at the time of study commencement.
- Referral information is not suggestive of an IgE mediated food allergy.
- Complex referral history suggestive of chronic urticaria, mast cell disorders or eosinophilic oesophagitis.
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 |
|---|---|---|
| "Myth busting" information leafletA written patient information leaflet displaying ten food allergy myths with the myth-busting evidence-based information clearly stated, focusing on themes pertinent to the myth-busting information | Behavioural | Received written patient information leaflet |
Primary outcome
Primary Outcome 1
Time frame: 2 weeks
Change in score in each group on Food Allergy Quality of Life Questionnaire (FAQLQ)-Parental Proxy Form
Primary Outcome 2
Time frame: 2 weeks
Change in score in each group on Food Allergy Independent Measurement (FAIM)
Primary Outcome 3
Time frame: 2 weeks
Change in score in each group on Food Allergy Anxiety Scale (FAAS)
1 secondary outcome
Secondary score
Time frame: 2 weeks
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 24 Jan 2024.
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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.
Aideen Byrne, PhD principal investigator
Children's Health Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Myth busting" information leaflet in people with Child Allergy and Food Allergy, run by Children's Health Ireland at 1 site in Ireland.
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 3 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 24 Jan 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 Ireland. 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?
Primary Outcome 1 (time frame: 2 weeks). The study lists 3 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 24 Jan 2024.