Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05458882 |
| Other study ID # |
120420 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2021 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
January 2024 |
| Source |
Children's Health Ireland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Over 4% of children in Ireland have a food allergy. Many studies report that parents and
children with food allergy have a decreased quality of life (QOL). However maternal anxiety
and parental overprotection even in the absence of FA can lead to childhood anxiety. Children
with FA are at risk of exclusion from social activities and overly restrictive lifestyles as
parents attempt to minimise risk and their own anxiety by avoiding food related activities.
The investigator's department carried out a prospective observation study collecting data on
lifestyle practice of food allergic children between 2-16 years attending their services and
the rate of accidental allergic reactions (AARs) over 1 year (Recording accidental allergic
reactions in children with food allergy: REAACT).
Most children in REACCT (which represents 25% of the return waiting list population) are
attending social activities and visiting food venues.
Caregivers can be influenced by high profile media cases which often report fatal AARs
occurring in food establishments and during social activities such as parties. The
psychological theories of availability heuristic (people make judgements on the likelihood of
an event on how easily a case comes to mind) and base case neglect (erroneously judge the
likelihood of a situation by failing to consider all relevant data, instead, focusing on new
information) can help explain how heavy reporting of rare severe/fatal AAR cases in the media
can increase anxiety among vulnerable parents and children leading to social exclusion and
avoidance of visiting eateries.
Conversely, there is no reporting of the thousands of food allergic children and families who
successfully manage their food allergies and manage to navigate events such as eating out and
social activities where food is an integral part. Hence, it is likely that families newly
diagnosed with nut allergy are not aware of how other families with established nut allergy
behave on a day to day basis.
A primary goal of the allergy clinic is to promote safe, age appropriate, social interaction
and eating out behaviors. Therefore, the investigators are interested in finding out whether
awareness of the successful management by a greater number of families with nut allergy in
Ireland, would impact on level of anxiety and health related quality of life of those newly
diagnosed with nut allergy? The investigators hypothesize that providing newly diagnosed
children and their parents with information on how other Irish children with established food
allergies behave in situations involving food will have a positive impact on their quality of
life and level of anxiety and promote "living with risk" rather than "living with fear".
Specifically, they aim to assess the effectiveness of a psycho-educational intervention
(illustrating the routine practices of food allergic children regarding social activities and
eating out) on disease-speciļ¬c quality of life and level of anxiety of newly diagnosed
parents and children.
A randomized control trial will be performed comparing quality of life, anxiety and self
efficacy in parents who receive the intervention versus those that do not. These parents will
have a young child with a newly diagnosed nut allergy.
