CBT Group Intervention for Children With Food Allergy and Anxiety

August 5, 2022 updated by: University of Surrey

Feasibility of a Group Intervention Using Cognitive Behavioural Therapy (CBT) to Reduce Anxiety for Children Aged 12-17 With Food Allergy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XH
        • University of Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Workshop Intervention
A psychoeducation workshop will be provided alongside a workbook containing the content to review and refresh skills learnt. The psychoeducational intervention will be delivered by trainee clinical psychologists with interests in food allergy and delivered in line with a protocol.
Behavioral: CBT workshop
The CBT based intervention for adolescents will include psychoeducation on food allergy and anxiety and also focus on providing skills, knowledge and support.
No Intervention: Treatment as usual
Adolescents randomised to the control arm will continue treatment as usual and receive the workshop materials after the active treatment group have completed their final follow-up at 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Food Allergy Quality of Life Questionnaire (FAQLQ-CF) - Child Form (8-12 years) or Teenager Form (13-17 years)
Time Frame: Baseline, 1 month & 3 month post follow ups
Child reported quality of life measure specific to food allergy. The FAQLQ-CF provides a self-report on the child's Health Related Quality of Life and contains 24 items and four domains (Risk of Accidental Exposure, Emotional Impact, Allergen Avoidance and Dietary Restrictions) Items were scored on a seven-point scale ranging from not troubled to extremely troubled. For the child form, in order to improve understanding, the scale was illustrated by drawings of faces ('smileys'), ranging from a smiling face to a sad face. The total FAQLQ score is the sum of all the items divided by the number of items and ranges from 1 (minimal impairment) to 7 (maximal impairment).
Baseline, 1 month & 3 month post follow ups
Change in Penn State Worry Questionnaire for Children (PSWQ-C)
Time Frame: Baseline, 1 month & 3 month post follow ups
Child reported worry measure. Respondents are asked to rate how often each item applies to them by choosing from a 4-point Likert scale consisting of never (0), sometimes (1), often (2) and always (3). The scores from each item are summed together to yield a total score that ranges from 0-42, with higher scores reflecting higher levels of worry.
Baseline, 1 month & 3 month post follow ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Coping Strategies Inventory (CSI)
Time Frame: Baseline, 1 month & 3 month post follow ups
Assesses coping thoughts and behaviours in response to a specific stressor (food allergy). After describing a stressful situation, persons taking the CSI are asked to respond to 32 questions in a 5-item Likert format. Respondents indicate for each item the extent to which they performed that particular coping response in dealing with the previously described situation (not at all, a little, somewhat, much, very much). Current scoring practices for the CSI involve giving all items in a particular subscale equalweights. To obtain the raw score for a subscale, simply add the item scores. With the higher score suggesting more use of that strategy.
Baseline, 1 month & 3 month post follow ups
Change in Adherence to food allergy specific self-care behaviours
Time Frame: Baseline, 1 month & 3 month post follow ups
Assessment of adherence to food allergy specific self-care behaviours. Questionnaire. Five items. Responses are measured on a 6-point scale (0-5) how much each statement applies to them. Higher the score suggests poorer self-care behaviours.
Baseline, 1 month & 3 month post follow ups
Change in Food Allergy Quality of Life Questionnaire (FAQLQ-PF)- Parent Form (8-12 years) or Parent Form (13-17 years)
Time Frame: Baseline, 1 month & 3 month post follow ups
Parent reported survey of child quality of life. The FAQLQ-PF provides a parent report on the child's Health related quality of life and contains 30 items for children aged 0-12 (child form) and 13-17 (teenager form) years. Items are divided into three domains (Emotional Impact, Food Anxiety and Social & Dietary Limitations) and scored in the same way as the FAQLQ-CF.
Baseline, 1 month & 3 month post follow ups
Intervention Feedback Survey
Time Frame: 3 month post workshop
Satisfaction and experience with intervention, Client Change Interview Schedule
3 month post workshop
Change in Goals based outcome measure
Time Frame: Baseline, 1 month & 3 month post follow ups
Goals from workshop and success at achieving on a scale from 0 (Goal not at all met) to 10 (Goal achieved). The higher the score, the better the outcome.
Baseline, 1 month & 3 month post follow ups

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: Baseline
Food allergy and anxiety characteristics
Baseline
Feasibility of the intervention in terms of the number interested, recruited and completion of the intervention.
Time Frame: 3 months post workshop
Number of children invited to the study, number of children interested in participating in the study, number of children meeting eligibility criteria, number of children recruited and participating in the intervention, number of children that completed the intervention.
3 months post workshop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Investigators

  • Principal Investigator: Holly Tallentire, BSc, University of Surrey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHMS 20-21 002 EGA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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