Title: Developing and feasibility testing an evidence informed low intensity psychological intervention for parents of children with food allergy
Funder: Health Education England

Abstract: Background to the research Paediatric food allergy (PFA) is a major paediatric health problem affecting 1 in 12 children1,2,3,4. Allergic reactions range from mild to severe and can be life threatening6,7.There is strong evidence that PFA has a significant impact on parental mental health and quality of life, with a recognition of the anxiety that food allergies can cause2,7,8,9,10. Parental allergy anxiety is complex and warrants in-depth attention.The proposed research study has three main aims: To develop a theoretical model of parental anxiety in paediatric food allergy (PFA) with the aim of improving understanding. To develop, via co-production, an evidence informed psychological intervention for parents of food allergic children, which aims to be highly acceptable and useable. To feasibility test to determine whether the intervention will be recommended for a larger scale clinical effectiveness trial. Research Questions Work Package One: Developing a theoretical understanding of allergy anxiety. RQ1a: How do parents experience anxiety in PFA? RQ1b What are the risk factors for parental anxiety symptoms in PFA? What is the range and nature of anxiety symptoms in parents of children with food allergy? Which measures of anxiety have been used in previous PFA studies and what are their psychometric properties of reliability and validity? Work Package Two: Developing a complex intervention. RQ2a:What are the psychosocial outcomes of existing parent psychological interventions in PFA? What is the content of existing parent psychological interventions in PFA? RQ2b: What are the goals of the low intensity PFA parent psychological intervention targeting allergy anxiety? What will the content of this low intensity PFA parent psychological intervention be? Work Package Three: Feasibility testing RQ3: Does the low intensity psychological intervention for parental allergy anxiety require further refinement? Is the intervention for parental allergy anxiety to be recommended for larger scale clinical effectiveness testing? Plan of the investigation Medical Research Council (MRC) guidance on the development and evaluation of complex interventions has been followed11.Firstly, a grounded theory model of parental anxiety in PFA will be developed via in-depth parent interviews. Potential risk factors for developing parental anxiety in PFA will be identified from a systematic search and meta-analysis synthesis of existing observational study literature. If data is available a point prevalence analysis of parent anxiety symptoms will be executed. This allergy specific theoretical understanding of parental anxiety will be used to inform the development of a low intensity psychological intervention. A contemporary systematic review of existing psychological interventions in PFA will be carried out prior to starting intervention development, with updates throughout. In order to maximize usability and acceptability, the evidence informed low intensity psychological intervention, an allergy anxiety toolkit will be developed with parents for parents, via co-production. Expert and parent focus groups will inform intervention development.Finally, the intervention will be feasibility tested in two clinical sites. Whilst the content of the intervention will be informed and determined by findings from work packages 1 and 2, it is anticipated that it will be delivered in parent groups and will include psychoeducation and cognitive behavioural strategies to manage and reduce allergy anxiety.Potential benefits to patients and the NHS In order to maximize patient benefit, the research targets parental allergy anxiety as an early intervention strategy. Improving understanding of psychological aspects of PFA will have immediate benefit for patients and clinical teams.The intervention design will aim to reduce parental anxiety and improve quality of life. Feasibility testing will tell us whether further refinement of the intervention is needed and whether the intervention should be recommended for a larger scale clinical effectiveness trial.

Lay abstract: Food allergy in children is a major health problem, with costs to families and the NHS. Approximately 1 in 12 children have a reported food allergy. Allergic reactions range from mild to severe. They can cause skin rashes, breathing difficulties, life threatening reactions and in some cases death. Research tells us that parents of children with food allergy report anxiety symptoms. Research is needed to better understand the experience of allergy anxiety. We know that a child is more likely to develop anxiety if one or both of the parents are anxious. Helping parents may reduce anxiety in both parent and child. Despite this, there has been little research carried out to find out how to help parents with allergy anxiety.Aims of the research This research aims to improve our understanding of parent allergy anxiety. Sharing this knowledge will benefit parents, children, family members and NHS staff. Additionally, this research aims to find a way of helping parents reduce their allergy anxiety. The study will develop a parent psychological intervention, a toolkit' for allergy anxiety. The psychological toolkit aims to help parents learn skills to manage their own allergy anxiety and as far as reasonably possible, better address their child's anxiety. It will be developed with parents, for parents. This study will not tell us whether the toolkit will reduce parental anxiety. But it will tell us whether parents like it and whether it needs more work or if it is complete. It will also tell us whether it would be worthwhile doing a larger study which could tell us whether it is effective.Design and methods used Firstly, I will carry out in-depth interviews with parents to develop a rich understanding of parent's anxieties, worries and fears about their child's food allergy. Additionally, I will complete a review of relevant research findings. I will analyse data from journals to find out which risk factors may be linked to parents developing allergy anxiety. Secondly, I will review the strengths and weaknesses of the small number of studies that have offered psychological help to parents of children with food allergy. I will use the research findings, clinical experience and expert groups to help me design a psychological toolkit for allergy anxiety. I will work with parents to produce a toolkit that is for parents. Parent focus groups will be completed at an early stage of development and following refinement of the toolkit. These focus groups will discuss how parents would want their experience of anxiety to be different. It will also seek their views on the proposed psychological toolkit. Stakeholder interviews will be carried out with NHS staff about introducing the toolkit for testing. Finally, the psychological toolkit will be feasibility tested. We expect the toolkit to be delivered in parent groups. Parents referred into the group will complete questionnaire measures, before, during and after. We will also follow parents up after 3 months. Testing the toolkit will tell us if any changes are needed. This study will not give us an answer to the question of whether the toolkit reduces anxiety and improves quality of life. It will tell us though whether we should do a larger study to test whether it leads to these improvements for parents.Patient and Public Involvement Patient and public involvement (PPI) will be at the heart of this study. We will set up an Advisory Group of carers of allergic children. This group will oversee and advise on the project. Additionally, a funding application will be made for a parent to join me on a King's Fund training programme. The training helps clinicians and carers work together on leading a project. It will help us to work collaboratively on the parent toolkit development for allergy anxiety. This PPI input will complement the parent focus groups which form part of the research design. PPI feedback will be sought on patient facing documents, ethics applications and recruitment strategies. Dissemination With the shared involvement of the research team in specialist bodies (British Society of Allergy and Clinical Immunology, Paediatric Psychology Network UK, British Association of Cognitive and Behaviour Therapy, Paediatric Allergy Network East Anglia) and with PPI Support, we will disseminate the findings of the study amongst specialists through journal publications and conferences. PPI group members will be involved in public dissemination, using social media, newsletters and parent community groups. Study findings will also be shared with local NHS bodies.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: INFLAMMATORY AND IMMUNE SYSTEM;MENTAL HEALTH