The Impact of an Evidence-based Myth-busting Information Intervention on Maternal Food Allergy Related Quality of Life, Anxiety and Self-efficacy

NCT06221540 | Completed

• 1 other identifier: GEN/894/21
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Child Allergy; Food Allergy

Keywords

Educational intervention; Food Allergy; Quality of Life; Anxiety; Self efficacy; Maternal education; Booklet; Immune System Diseases; Hypersensitivity, Immediate; Food Hypersensitivity

Outcome Measures

Primary Outcomes (3)

• Primary Outcome 1

  Change in score in each group on Food Allergy Quality of Life Questionnaire (FAQLQ)-Parental Proxy Form

  2 weeks

• Primary Outcome 2

  Change in score in each group on Food Allergy Independent Measurement (FAIM)

  2 weeks

• Primary Outcome 3

  Change in score in each group on Food Allergy Anxiety Scale (FAAS)

  2 weeks

Secondary Outcomes (1)

• Secondary score

  2 weeks

Study Arms (2)

Received written patient information leaflet

EXPERIMENTAL

Behavioral: "Myth busting" information leaflet

Routine education at first clinic appointment

NO INTERVENTION

Active Comparator

Interventions

"Myth busting" information leaflet BEHAVIORAL

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

Received written patient information leaflet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Health Ireland: lead

Study Sites (1)

Children's Health Ireland

Dublin, Ireland

Location

MeSH Terms

Conditions

Food Hypersensitivity; Anxiety Disorders; Immune System Diseases; Hypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Hypersensitivity; Mental Disorders

Study Officials

• Aideen Byrne, PhD

  Children's Health Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: May 21, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

IE (1)