Clinical trial NCT04770727: CBT Group Intervention for Children With Food Allergy and Anxiety
Official title: Feasibility of a Group Intervention Using Cognitive Behavioural Therapy (CBT) to Reduce Anxiety for Children Aged 12-17 With Food Allergy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy in Children
Keywords: Food Allergy
Anxiety
Young People
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 52
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research will design and evaluate a CBT based intervention to support children aged 11-17 with food allergies. The research on this population has shown that they can experience high levels of anxiety in management of their allergy which can have a significant impact on quality of life. However, the research exploring psychological interventions is limited. CBT has a wide evidence base from NHS settings delivering interventions to support those with various health conditions. In addition, CBT has been shown to be effective for supporting adolescents manage their health-related anxiety. The investigators are interested in the feasibility of designing and implementing a one day workshop aimed at adolescents with food allergy and self-reported anxiety. The group workshop will involve psychoeducation on anxiety, skills and techniques to manage anxiety, relaxation and how to set goals in relation to their food allergy. It will involve 2 'arms', one where participants will attend the group and the other 'control arm' where they will not attend the group but they will receive materials from the group once the evaluation is complete. All participants will be asked to complete questionnaires that measure level of anxiety, food allergy quality of life and coping skills at baseline, time of workshop, one month follow up and three month follow up. There will also be an opportunity for participants to volunteer to take part in a follow up interview to evaluate the workshop and also to contribute more to the research on what this population requires in terms of a psychological intervention.

Detailed description: Food allergy is an increasing public health concern, with Westernised countries reporting prevalence of diagnosed allergies of up to 10%, most notably among younger children. Over the last few decades, the number of people diagnosed with food allergy has been increasing, as has the awareness of the psychological burden of living with a food allergy. As the symptoms lie on a spectrum with fatal anaphylaxis being a possible result of exposure, avoidance of the allergen and having access to emergency medication (e.g. adrenaline auto-injectors) remains the primary care for management Unlike other allergies which can be more easily avoided (i.e. animals), food can be hidden in products without awareness and so a reaction could occur by mistake. This can then result in a significant impact on Quality of Life (QoL) for those with an allergy and their family. Children with peanut allergies reporting more fear of an adverse event and anxiety around managing their condition compared to peers with insulin-dependent diabetes mellitus. In addition, the dietary and social restrictions accompanying the management of food allergy can result in children feeling social isolated or even bullied.

Anxiety is a normal part of human experience as it is an appropriate response to uncertain or unpredictable situations, however when anxiety is excessive it can cause great distress and interfere with daily functioning. In regards to the management of an allergy, some level of anxiety is adaptive as anxious children are less likely to take risks in terms of exposure to the allergen compared to those who are less anxious. However, sometimes the anxiety around a fatal reaction can result in avoidance of social situations, not allowing age appropriate outings or having an excessively restricted diet which could have implications for children's growth and development. The optimal emotional response has been described as 'relaxed readiness' in order to allow for effective food allergy management whilst minimizing more maladaptive aspects of anxiety such as hypervigilance or avoidance.

Research has identified that adolescents and young people are the age group most at risk for fatal anaphylaxis to foods. As well as this, having a food allergy is related to increased risk of anxiety within this age group. Reaching adolescence is usually the development of personal autonomy and independence and for those with food allergies is the time where they take more responsibility for the management of their allergy and the subsequent psychosocial impact. Adolescents report feeling misunderstood by others and speak about the psychological consequences of 'being different'.

Considering the 'relaxed readiness' response, interventions for patients with food allergy should aim to recognise, normalise and support levels of anxiety that can allow for more adaptive coping strategies. Adolescents with more avoidant coping strategies (such as avoiding social events or places where they could be exposed to the allergen) are associated with higher trait anxiety, believed to be linked to years of fear of exposure to their allergen. Coping skills that are developed in adolescent tend to persist into adulthood and those which are more constructive have a more positive impact on wellbeing as well as adherence to medical advice. Therefore, an intervention would be beneficial to target a reduction in maladaptive coping techniques and increase adaptive cognitive behavioural problem-solving approach.

A recent systematic review into the effectiveness of interventions to improve self-management for adolescents with allergic conditions found all interventions that met their criteria to be for asthma, highlighting the need for interventions for those with food allergies. A systematic review into the impact of anaphylaxis and anxiety highlighted the need for Cognitive Behavioural Therapy (CBT) based intervention. CBT has also shown to be effective in supporting children with health conditions in managing distress, increased competence in mastering the challenges of adolescence and improvement in coping skills. Although little is known about CBT for children with food allergies, interventions using CBT for parents of children with food allergies have shown to be effective in reducing levels of worry and anxiety and improving quality of life. In recent research, a single session intervention reduced anxiety in the long term and CBT as a single session intervention has been shown to reduce anxiety in young people with anxiety. As the literature has highlighted feelings of not being understood by peers and feeling different, it may be beneficial to offer adolescents the opportunity to meet others in a similar situation. Group intervention is recommended for adolescents as it can be reassuring that patients concerns are shared and discussions can promote more adaptive ways of coping.

The current study addresses the need highlighted in the literature to provide adolescents who experience increased anxiety due to their food allergy with a CBT based intervention to manage the impact of this. This research will design and provide a one-day group CBT workshop for children ages 11-17 with a food allergy and self-reported anxiety. There will also be an optional interview for those who attended the workshop to discuss how they found it and their experiences of living with a food allergy. The results will contribute to the current literature on how anxiety and food allergy are related as well as the feasibility of delivering a CBT workshop for this client group.

Eligibility criteria: Inclusion Criteria:

* Children and Adolescents ages 11-17 years with a food allergy.
* To have reported anxiety or worry in relation to management of food allergy.
* Able to attend the one-day workshop at the University of Surrey to complete the intervention in full (or online alternative).
* Willing and able to comprehend English and provide assent/consent.

Exclusion Criteria:

* Child does not speak English.
* Able and willing to engage and understand the content of the workshop.
* Currently under a mental health team and receiving ongoing psychological input.
* Do not have the capacity to provide informed assent/consent and/or consent not gained from caregivers.

Primary outcomes:
measure: Change in Food Allergy Quality of Life Questionnaire (FAQLQ-CF) - Child Form (8-12 years) or Teenager Form (13-17 years)
timeFrame: Baseline, 1 month & 3 month post follow ups
measure: Change in Penn State Worry Questionnaire for Children (PSWQ-C)
timeFrame: Baseline, 1 month & 3 month post follow ups
Secondary outcomes:
measure: Change in Coping Strategies Inventory (CSI)
timeFrame: Baseline, 1 month & 3 month post follow ups
measure: Change in Adherence to food allergy specific self-care behaviours
timeFrame: Baseline, 1 month & 3 month post follow ups
measure: Change in Food Allergy Quality of Life Questionnaire (FAQLQ-PF)- Parent Form (8-12 years) or Parent Form (13-17 years)
timeFrame: Baseline, 1 month & 3 month post follow ups
measure: Intervention Feedback Survey
timeFrame: 3 month post workshop
measure: Change in Goals based outcome measure
timeFrame: Baseline, 1 month & 3 month post follow ups
Other outcomes:
measure: Demographics
timeFrame: Baseline
measure: Feasibility of the intervention in terms of the number interested, recruited and completion of the intervention.
timeFrame: 3 months post workshop
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey
state: Surrey
Study officials:
affiliation: University of Surrey
name: Holly Tallentire, BSc
role: PRINCIPAL_INVESTIGATOR
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