CBT Group Intervention for Children With Food Allergy and Anxiety

NCT04770727 | Completed DMC

• 1 other identifier: FHMS 20-21 002 EGA
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy in Children

Keywords

Food Allergy; Anxiety; Young People

Outcome Measures

Primary Outcomes (2)

• Change in Food Allergy Quality of Life Questionnaire (FAQLQ-CF) - Child Form (8-12 years) or Teenager Form (13-17 years)

  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)

  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 Outcomes (5)

• Change in Coping Strategies Inventory (CSI)

  Baseline, 1 month & 3 month post follow ups

• Change in Adherence to food allergy specific 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)

  Baseline, 1 month & 3 month post follow ups

• Intervention Feedback Survey

  3 month post workshop

• Change in Goals based outcome measure

  Baseline, 1 month & 3 month post follow ups

Other Outcomes (2)

• Demographics

  Baseline

• Feasibility of the intervention in terms of the number interested, recruited and completion of the intervention.

  3 months post workshop

Study Arms (2)

Workshop Intervention

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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.

Interventions

CBT workshop BEHAVIORAL

The CBT based intervention for adolescents will include psychoeducation on food allergy and anxiety and also focus on providing skills, knowledge and support.

Workshop Intervention

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

Related Publications (26)

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  PMID: 39069154 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity; Anxiety Disorders

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mental Disorders

Study Officials

• Holly Tallentire, BSc

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 25, 2021
• Study Start: February 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

GB (1)