Food Allergy in ChildrenNCT04770727
CBT Group Intervention for Children With Food Allergy and Anxiety
A study testing CBT workshop in people with Food Allergy in Children, run by University of Surrey at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy in Children
- What is being tested?
- CBT workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 31 Jan 2022
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Food Allergy in Children
- Being tested
- CBT workshop
- Keywords
- Food Allergy, Anxiety, Young People
- 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.
CBT workshopBehavioural
The CBT based intervention for adolescents will include psychoeducation on food allergy and anxiety and also focus on providing skills, knowledge and support.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline, 1 month & 3 month post follow ups
Secondary outcomes (5)
Change in Coping Strategies Inventory (CSI)
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.
Measured: Baseline, 1 month & 3 month post follow ups
Change in Adherence to food allergy specific self-care behaviours
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.
Measured: 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)
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.
Measured: Baseline, 1 month & 3 month post follow ups
Intervention Feedback Survey
Satisfaction and experience with intervention, Client Change Interview Schedule
Measured: 3 month post workshop
Change in Goals based outcome measure
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.
Measured: Baseline, 1 month & 3 month post follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Feb 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Food Allergy in ChildrenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Tallentire, BSc, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770727
- Sponsor's protocol ID
- FHMS 20-21 002 EGA
- Status last verified
- Aug 2022
- First submitted
- 18 Feb 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loh W, Tang MLK. The Epidemiology of Food Allergy in the Global Context. Int J Environ Res Public Health. 2018 Sep 18;15(9):2043. doi: 10.3390/ijerph15092043.
PubMed 30231558Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Host A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9.
PubMed 24909706Avery NJ, King RM, Knight S, Hourihane JO. Assessment of quality of life in children with peanut allergy. Pediatr Allergy Immunol. 2003 Oct;14(5):378-82. doi: 10.1034/j.1399-3038.2003.00072.x.
PubMed 14641608Cummings AJ, Knibb RC, Erlewyn-Lajeunesse M, King RM, Roberts G, Lucas JS. Management of nut allergy influences quality of life and anxiety in children and their mothers. Pediatr Allergy Immunol. 2010 Jun;21(4 Pt 1):586-94. doi: 10.1111/j.1399-3038.2009.00975.x. Epub 2010 Jan 14.
PubMed 20088863Ravid NL, Annunziato RA, Ambrose MA, Chuang K, Mullarkey C, Sicherer SH, Shemesh E, Cox AL. Mental health and quality-of-life concerns related to the burden of food allergy. Psychiatr Clin North Am. 2015 Mar;38(1):77-89. doi: 10.1016/j.psc.2014.11.004. Epub 2014 Dec 20.
PubMed 25725570Muraro A, Polloni L, Lazzarotto F, Toniolo A, Baldi I, Bonaguro R, Gini G, Masiello M. Comparison of bullying of food-allergic versus healthy schoolchildren in Italy. J Allergy Clin Immunol. 2014 Sep;134(3):749-51. doi: 10.1016/j.jaci.2014.05.043. Epub 2014 Jul 18. No abstract available.
PubMed 25042742Gross C, Hen R. The developmental origins of anxiety. Nat Rev Neurosci. 2004 Jul;5(7):545-52. doi: 10.1038/nrn1429. No abstract available.
PubMed 15208696Mandell D, Curtis R, Gold M, Hardie S. Anaphylaxis: how do you live with it? Health Soc Work. 2005 Nov;30(4):325-35. doi: 10.1093/hsw/30.4.325.
PubMed 16323724Klinnert MD, Robinson JL. Addressing the psychological needs of families of food-allergic children. Curr Allergy Asthma Rep. 2008 May;8(3):195-200. doi: 10.1007/s11882-008-0033-7.
PubMed 18589837Polloni L, Toniolo A, Lazzarotto F, Baldi I, Foltran F, Gregori D, Muraro A. Nutritional behavior and attitudes in food allergic children and their mothers. Clin Transl Allergy. 2013 Dec 10;3(1):41. doi: 10.1186/2045-7022-3-41.
PubMed 24325875Walkner M, Warren C, Gupta RS. Quality of Life in Food Allergy Patients and Their Families. Pediatr Clin North Am. 2015 Dec;62(6):1453-61. doi: 10.1016/j.pcl.2015.07.003. Epub 2015 Sep 8.
PubMed 26456443Turner PJ, Gowland MH, Sharma V, Ierodiakonou D, Harper N, Garcez T, Pumphrey R, Boyle RJ. Increase in anaphylaxis-related hospitalizations but no increase in fatalities: an analysis of United Kingdom national anaphylaxis data, 1992-2012. J Allergy Clin Immunol. 2015 Apr;135(4):956-963.e1. doi: 10.1016/j.jaci.2014.10.021. Epub 2014 Nov 25.
PubMed 25468198Ferro MA, Van Lieshout RJ, Scott JG, Alati R, Mamun AA, Dingle K. Condition-specific associations of symptoms of depression and anxiety in adolescents and young adults with asthma and food allergy. J Asthma. 2016;53(3):282-8. doi: 10.3109/02770903.2015.1104694. Epub 2016 Jan 21.
PubMed 26539899MacKenzie H, Roberts G, van Laar D, Dean T. Teenagers' experiences of living with food hypersensitivity: a qualitative study. Pediatr Allergy Immunol. 2010 Jun;21(4 Pt 1):595-602. doi: 10.1111/j.1399-3038.2009.00938.x. Epub 2009 Aug 21.
PubMed 19702674DunnGalvin A, Gaffney A, Hourihane JO. Developmental pathways in food allergy: a new theoretical framework. Allergy. 2009 Apr;64(4):560-8. doi: 10.1111/j.1398-9995.2008.01862.x. Epub 2009 Jan 9.
PubMed 19154549
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Group Intervention Using Cognitive Behavioural Therapy (CBT) to Reduce Anxiety for Children Aged 12-17 With Food Allergy.
- ClinicalTrials.gov ID
- NCT04770727
- Acronym / sponsor ID
- FHMS 20-21 002 EGA
- Conditions
- Food Allergy in Children
- Keywords
- Food Allergy, Anxiety, Young People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 25 Feb 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workshop Intervention | Experimental | Behavioral: CBT workshopA 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. |
| 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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| CBT workshopThe CBT based intervention for adolescents will include psychoeducation on food allergy and anxiety and also focus on providing skills, knowledge and support. | Behavioural | Workshop Intervention |
Primary outcome
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).
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.
5 secondary outcomes
Change in Coping Strategies Inventory (CSI)
Time frame: 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
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
Intervention Feedback Survey
Time frame: 3 month post workshop
Change in Goals based outcome measure
Time frame: Baseline, 1 month & 3 month post follow ups
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 10 Aug 2022.
- Background: PubMed 30231558Loh W, Tang MLK. The Epidemiology of Food Allergy in the Global Context. Int J Environ Res Public Health. 2018 Sep 18;15(9):2043. doi: 10.3390/ijerph15092043.
- Background: PubMed 24909706Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Host A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9.
- Background: PubMed 14641608Avery NJ, King RM, Knight S, Hourihane JO. Assessment of quality of life in children with peanut allergy. Pediatr Allergy Immunol. 2003 Oct;14(5):378-82. doi: 10.1034/j.1399-3038.2003.00072.x.
- Background: PubMed 20088863Cummings AJ, Knibb RC, Erlewyn-Lajeunesse M, King RM, Roberts G, Lucas JS. Management of nut allergy influences quality of life and anxiety in children and their mothers. Pediatr Allergy Immunol. 2010 Jun;21(4 Pt 1):586-94. doi: 10.1111/j.1399-3038.2009.00975.x. Epub 2010 Jan 14.
- Background: PubMed 25725570Ravid NL, Annunziato RA, Ambrose MA, Chuang K, Mullarkey C, Sicherer SH, Shemesh E, Cox AL. Mental health and quality-of-life concerns related to the burden of food allergy. Psychiatr Clin North Am. 2015 Mar;38(1):77-89. doi: 10.1016/j.psc.2014.11.004. Epub 2014 Dec 20.
- Background: PubMed 25042742Muraro A, Polloni L, Lazzarotto F, Toniolo A, Baldi I, Bonaguro R, Gini G, Masiello M. Comparison of bullying of food-allergic versus healthy schoolchildren in Italy. J Allergy Clin Immunol. 2014 Sep;134(3):749-51. doi: 10.1016/j.jaci.2014.05.043. Epub 2014 Jul 18. No abstract available.
- Background: PubMed 15208696Gross C, Hen R. The developmental origins of anxiety. Nat Rev Neurosci. 2004 Jul;5(7):545-52. doi: 10.1038/nrn1429. No abstract available.
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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.
Holly Tallentire, BSc principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT workshop in people with Food Allergy in Children, run by University of Surrey at 1 site in United Kingdom.
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 4 inclusion and 4 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 10 Aug 2022. 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 United Kingdom. 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?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04770727, which also lists 26 linked publications.
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 10 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.