Impact of an Educational Tool on Quality of Life and Anxiety in Parents of Children With Nut Allergy

NCT05458882 | Completed

• 1 other identifier: 120420
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The number of young children with food allergy, in particular with nut allergy, is increasing worldwide. A diagnosis of nut allergy can cause much anxiety in parents. They worry about their child being exposed to nuts in foods when outside the home. This anxiety can lead to these young children being restricted from taking part in normal childhood activities. Last year, the investigators conducted a study Recording accidental allergic reactions in children's and teenagers (ReAACT) in which they surveyed over 500 children with food allergy attending our clinic, in order to learn more about their participation in social activities and their practices in relation to eating outside the home. In the present study, the investigators wish to build upon these results through using the findings to develop a programme to help to lessen the fear and anxiety experienced by parents of young children with newly diagnosed nut allergy. The investigators imagine that knowledge of how other families with children who have food allergy participate in activities involving food outside of the home might help newly diagnosed families. The investigators would like to know if parents of young children newly diagnosed with nut allergy would benefit from hearing this information. In order to do this, the investigators have developed a short online programme that parents can take part in, in their own homes. Content will focus on the day to day social activities of children with food allergy, based on the findings of the REAACT study. To help the investigators to measure the effectiveness of this programme on reducing anxiety and improving quality of life, they are asking all volunteer participants to complete 4 questionnaires. Two of these questionnaires will ask a parent to indicate 1) the impact of their child's nut allergy on their quality of life and 2) on their child's quality of life. The third questionnaire will ask about their level of anxiety. The fourth questionnaire will ask about their emotions and the coping strategies they use in the context of their child's food allergy. Participants will be randomized into 2 groups. Group 1 will take part in the online education session along with the usual education provided by the allergy team. The questionnaires will be completed online using only a study identifier number. This will ensure anonymity throughout the study. The only personal information that will be asked is parent's age group, whether they are a mother or father, their child's age and gender and whether they have any other allergies. Two weeks following the online educational session, Groups 1 and 2 will again complete the online questionnaires. The research question is to determine if the online educational session is effective at decreasing anxiety and improving quality of life in parents of young children with nut allergy. The outcomes are health related quality of life and level of anxiety. It is hoped that the findings will positively support parents, children and their families in Ireland who are living and managing nut allergy on a daily basis.

Conditions

Child Allergy; Food Allergy

Keywords

Educational intervention; Food allergy; Quality of Life; Anxiety; Self efficacy; Maternal education; Booklet

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

  4 weeks

• Primary Outcome 2

  Change in score in each group on Food Allergy Quality of Life (FAQOL) parental burden form

  4 weeks

• Primary Outcome 3

  Change in score in each group on Stait and Trait anxiety inventory (STAI)

  4 weeks

Secondary Outcomes (1)

• Secondary Score

  4 weeks

Study Arms (2)

educational Booklet

EXPERIMENTAL

Receive intervention- educational booklet describing the day to day social activities and eating out habits of children with established food allergy in Ireland

Behavioral: "living with food allergy" educational booklet

Routine education

ACTIVE COMPARATOR

This group will receive routine education in the allergy group.

Behavioral: "living with food allergy" educational booklet

Interventions

"living with food allergy" educational booklet BEHAVIORAL

An educational booklet giving information on social and eating out habits as well as reaction rates in food allergy Irish children.

Routine education; educational Booklet

Eligibility Criteria

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

You may qualify if:

• Parents of children between 6 and 36 months
• Parent of children with a new diagnosis of a nut allergy defined as a clinical reaction with a skin prick test (SPT) of \>3mm or sensitised with a SPT of \>7mm.

You may not qualify if:

• Parents who already had a child with a food allergy as parents would have well established coping mechanisms
• Participation in another research project
• Their food allergic child had another chronic condition that might cause anxieties in social environments.

Sponsors & Collaborators

• Children's Health Ireland: lead

Study Sites (1)

Children's Health Ireland

Dublin, Ireland

Location

MeSH Terms

Conditions

Food Hypersensitivity; Anxiety Disorders

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mental Disorders

Study Officials

• Miranda Crealey, MD

  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: July 8, 2022
• First Posted: July 14, 2022
• Study Start: May 25, 2021
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)