Child AllergyNCT05458882
Impact of an Educational Tool on Quality of Life and Anxiety in Parents of Children With Nut Allergy
A study testing "living with food allergy" educational booklet in people with Child Allergy and Food Allergy, run by Children's Health Ireland at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Allergy, Food Allergy
- What is being tested?
- "living with food allergy" educational booklet
- 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
- 25 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Educational Tool on Quality of Life and Anxiety in Parents of Young Children With Newly Diagnosed Nut Allergy
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.
Read more
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.
Read the detailed 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-specific 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.
- Conditions
- Child Allergy, Food Allergy
- Being tested
- "living with food allergy" educational booklet
- Keywords
- Educational intervention, Food allergy, Quality of Life, Anxiety, Self efficacy, Maternal education, Booklet
- Medical subject headings
- Food Hypersensitivity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"living with food allergy" educational bookletBehavioural
An educational booklet giving information on social and eating out habits as well as reaction rates in food allergy Irish children.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: "living with food allergy" educational booklet |
| Routine education | Active comparator | This group will receive routine education in the allergy group. Receives: Behavioral: "living with food allergy" educational booklet |
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: 4 weeks
Primary Outcome 2
Change in score in each group on Food Allergy Quality of Life (FAQOL) parental burden form
Measured: 4 weeks
Primary Outcome 3
Change in score in each group on Stait and Trait anxiety inventory (STAI)
Measured: 4 weeks
Secondary outcomes (1)
Secondary Score
Change in score on Self efficacy in Food Allergy Questionnaire (SEFAQ)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start25 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
- Miranda Crealey, MD, Principal investigator, Children's Health Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458882
- Sponsor's protocol ID
- 120420
- Status last verified
- Jan 2024
- First submitted
- 8 Jul 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Educational Tool on Quality of Life and Anxiety in Parents of Young Children With Newly Diagnosed Nut Allergy
- ClinicalTrials.gov ID
- NCT05458882
- Acronym / sponsor ID
- 120420
- Conditions
- Child Allergy, Food Allergy
- Keywords
- Educational intervention, Food allergy, Quality of Life, Anxiety, Self efficacy, Maternal education, Booklet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Children's Health IrelandOther government
- Study start
- 25 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 Jul 2022 (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.
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.
Detailed 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-specific 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| educational Booklet | Experimental | Behavioral: "living with food allergy" educational bookletReceive intervention- educational booklet describing the day to day social activities and eating out habits of children with established food allergy in Ireland |
| Routine education | Active comparator | Behavioral: "living with food allergy" educational bookletThis group will receive routine education in the allergy group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| "living with food allergy" educational bookletAn educational booklet giving information on social and eating out habits as well as reaction rates in food allergy Irish children. | Behavioural | Routine education, educational Booklet |
Primary outcome
Primary Outcome 1
Time frame: 4 weeks
Change in score in each group on Food allergy Quality of Life Questionnaire (FAQLQ) parental proxy form
Primary Outcome 2
Time frame: 4 weeks
Change in score in each group on Food Allergy Quality of Life (FAQOL) parental burden form
Primary Outcome 3
Time frame: 4 weeks
Change in score in each group on Stait and Trait anxiety inventory (STAI)
1 secondary outcome
Secondary Score
Time frame: 4 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 5 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Miranda Crealey, MD 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 "living with food allergy" educational booklet 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 2 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: finished, as of the sponsor's last update on 5 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: 4 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 5 Jan 2024.