Group CBT Intervention for Parents of Children With Food Allergy

NCT04774796 | Completed

• 1 other identifier: FHMS 20-21 005 EGA
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Food allergy has been found to have a profound impact on parents of children with food allergy, with caregivers experiencing poorer psychological outcomes such as increased stress, anxiety, worry and depression than parents of non-allergic children. Furthermore, they report poorer quality of life (QoL) due to the psychosocial impact of looking after a child with food allergy, identifying the need for parental interventions aimed at improving these outcomes. There has generally been a paucity of research in this area, but there has recently been encouraging evidence to suggest that interventions involving Cognitive Behavioural Therapy (CBT) have the potential to improve the lives of those parents impacted by a child's food allergy. This study aims to add to this emerging evidence base by reporting on the feasibility of a brief, group CBT intervention for parents of children with food allergy. This small, proof of concept study also aims to report on a range of psychological measures to see if there is any evidence that this intervention may be effective in improving outcomes. Thirty to forty parents of children with food allergy will be recruited to the study and randomised to receive either a one-day or two half-day group CBT intervention or treatment as usual. Measures of a range of psychological outcomes, food allergy specific QoL and goal-based outcomes will be taken at baseline and at one and three-month follow ups. Participants will be asked for their feedback so that researchers can report on the acceptability of the intervention for those involved. This study is also interested in hearing about the parental experience of accessing psychological therapies as it is still not clear why some parents may require psychological intervention whilst others may not; participants in the intervention group will be invited to take part in interviews in order to share their experiences. It is hoped that this set of findings will help to determine if a brief group CBT intervention could be recommended for efficacy testing as part of a wider effort to provide evidence-based treatments for parents of children with food allergy experiencing poor psychological outcomes and poor food allergic-specific QoL.

Conditions

Allergy;Food; Parents; Psychological Distress

Outcome Measures

Primary Outcomes (4)

• Change in Food Allergy Quality of Life - Parental Burden Scale (Cohen et al., 2004)

  17-item self-report scale which utilises a 7-point Likert scale in order to assess the burden of food allergy felt on the family. Higher scores represent greater parental burden.

  Baseline, and 1 & 3 month follow ups

• Change in Depression, Anxiety and Stress Scales; short form version (Lovibond & Lovibond, 1995)

  21-item self-report scale that is made up of three individual seven-item scales that measure depression, anxiety and stress. Higher scores represent higher levels of depression, anxiety and stress.

  Baseline, and 1 & 3 month follow ups

• Change in Penn State Worry Questionnaire (Meyer et al., 1990)

  16-item self-report scale to measure worry. Higher scores indicate greater worry.

  Baseline, and 1 & 3 month follow ups

• Feedback questionnaire (researcher developed)

  Participants in the intervention group will be asked to complete a feedback questionnaire, in order for researchers to evaluate the CBT intervention and assess acceptability and feasibility.

  3 month follow up

Secondary Outcomes (2)

• Change in Food Allergy Self-Efficacy Scale for Parents (Knibb, 2015)

  Baseline, and 1 & 3 month follow ups

• Change in Goal-Based Outcomes (researcher developed)

  1 & 3 month follow ups

Other Outcomes (1)

• Demographic Questionnaire (researcher developed)

  Baseline

Study Arms (2)

Cognitive Behavioural Therapy

EXPERIMENTAL

Participants in this group will take part in a group CBT workshop for parents of children with food allergy. They will also have access to a self-help booklet in order to reinforce the learning that has taken place during the workshop.

Other: Cognitive Behavioural Therapy

Treatment as usual

NO INTERVENTION

Participants in the control group will not take part in the group CBT workshop, but will have access to any treatment as usual relating to their child's food allergy. They will have access to the CBT self-help booklet after the all data collection has been finalised.

Interventions

Cognitive Behavioural Therapy OTHER

Participants will take part in a one day, or two half-day group CBT workshop for parents of children with food allergy. The workshop will included understanding difficulties using a CBT model, psychoeducation on common psychological issues (e.g. anxiety) and the development of skills to help deal with maladaptive cognitions and behaviours relating to managing a child's food allergy.

Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals must be the parent of at least one child with a diagnosed food allergy aged 0-17 years, currently experiencing difficulties with their wellbeing, in relation to their child's food allergy.

You may not qualify if:

• Individuals under the current care of a mental health care team or receiving any form of psychological intervention/treatment.
• Individuals taking part in another research study involving psychological intervention
• Individuals who do not have the capacity to provide informed consent
• Individuals who are not able to understand written and spoken English
• Individuals not able to access workshop materials (e.g. do not have an internet connection to take part in online workshops).

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

Related Publications (26)

• Akeson N, Worth A, Sheikh A. The psychosocial impact of anaphylaxis on young people and their parents. Clin Exp Allergy. 2007 Aug;37(8):1213-20. doi: 10.1111/j.1365-2222.2007.02758.x.

  PMID: 17651152 BACKGROUND

• Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM; NIAID-Sponsored Expert Panel. Guidelines for the Diagnosis and Management of Food Allergy in the United States: Summary of the NIAID-Sponsored Expert Panel Report. J Allergy Clin Immunol. 2010 Dec;126(6):1105-18. doi: 10.1016/j.jaci.2010.10.008. No abstract available.

  PMID: 21134568 BACKGROUND

• Boyle RJ, Umasunthar T, Smith JG, Hanna H, Procktor A, Phillips K, Pinto C, Gore C, Cox HE, Warner JO, Vickers B, Hodes M. A brief psychological intervention for mothers of children with food allergy can change risk perception and reduce anxiety: Outcomes of a randomized controlled trial. Clin Exp Allergy. 2017 Oct;47(10):1309-1317. doi: 10.1111/cea.12981. Epub 2017 Aug 10.

  PMID: 28710902 BACKGROUND

• Cartwright-Hatton S, Ewing D, Dash S, Hughes Z, Thompson EJ, Hazell CM, Field AP, Startup H. Preventing family transmission of anxiety: Feasibility RCT of a brief intervention for parents. Br J Clin Psychol. 2018 Sep;57(3):351-366. doi: 10.1111/bjc.12177. Epub 2018 Mar 25.

  PMID: 29575043 BACKGROUND

• Cohen BL, Noone S, Munoz-Furlong A, Sicherer SH. Development of a questionnaire to measure quality of life in families with a child with food allergy. J Allergy Clin Immunol. 2004 Nov;114(5):1159-63. doi: 10.1016/j.jaci.2004.08.007.

  PMID: 15536425 BACKGROUND

• Cummings 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.

  PMID: 20088863 BACKGROUND

• Gillespie CA, Woodgate RL, Chalmers KI, Watson WT. "Living with risk": mothering a child with food-induced anaphylaxis. J Pediatr Nurs. 2007 Feb;22(1):30-42. doi: 10.1016/j.pedn.2006.05.007.

  PMID: 17234496 BACKGROUND

• Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

  PMID: 16004657 BACKGROUND

• Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

  PMID: 18183564 BACKGROUND

• King RM, Knibb RC, Hourihane JO. Impact of peanut allergy on quality of life, stress and anxiety in the family. Allergy. 2009 Mar;64(3):461-8. doi: 10.1111/j.1398-9995.2008.01843.x. Epub 2008 Dec 4.

  PMID: 19076542 BACKGROUND

• Knibb RC. Effectiveness of Cognitive Behaviour Therapy for Mothers of Children with Food Allergy: A Case Series. Healthcare (Basel). 2015 Nov 25;3(4):1194-211. doi: 10.3390/healthcare3041194.

  PMID: 27417820 BACKGROUND

• Knibb RC, Barnes C, Stalker C. Parental confidence in managing food allergy: development and validation of the Food Allergy Self-Efficacy Scale for Parents (FASE-P). Clin Exp Allergy. 2015 Nov;45(11):1681-9. doi: 10.1111/cea.12599.

  PMID: 26215853 BACKGROUND

• Knibb RC, Semper H. Impact of suspected food allergy on emotional distress and family life of parents prior to allergy diagnosis. Pediatr Allergy Immunol. 2013 Dec;24(8):798-803. doi: 10.1111/pai.12176.

  PMID: 24329879 BACKGROUND

• Knibb R, Halsey M, James P, du Toit G, Young J. Psychological services for food allergy: The unmet need for patients and families in the United Kingdom. Clin Exp Allergy. 2019 Nov;49(11):1390-1394. doi: 10.1111/cea.13488. Epub 2019 Sep 8.

  PMID: 31454459 BACKGROUND

• Lau GY, Patel N, Umasunthar T, Gore C, Warner JO, Hanna H, Phillips K, Zaki AM, Hodes M, Boyle RJ. Anxiety and stress in mothers of food-allergic children. Pediatr Allergy Immunol. 2014 May;25(3):236-42. doi: 10.1111/pai.12233.

  PMID: 24750570 BACKGROUND

• LeBovidge JS, Timmons K, Rich C, Rosenstock A, Fowler K, Strauch H, Kalish LA, Schneider LC. Evaluation of a group intervention for children with food allergy and their parents. Ann Allergy Asthma Immunol. 2008 Aug;101(2):160-5. doi: 10.1016/S1081-1206(10)60204-9.

  PMID: 18727471 BACKGROUND

• Lopez-Lopez JA, Davies SR, Caldwell DM, Churchill R, Peters TJ, Tallon D, Dawson S, Wu Q, Li J, Taylor A, Lewis G, Kessler DS, Wiles N, Welton NJ. The process and delivery of CBT for depression in adults: a systematic review and network meta-analysis. Psychol Med. 2019 Sep;49(12):1937-1947. doi: 10.1017/S003329171900120X. Epub 2019 Jun 10.

  PMID: 31179960 BACKGROUND

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

• Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.

  PMID: 2076086 BACKGROUND

• Roy KM, Roberts MC. Peanut allergy in children: relationships to health-related quality of life, anxiety, and parental stress. Clin Pediatr (Phila). 2011 Nov;50(11):1045-51. doi: 10.1177/0009922811412584. Epub 2011 Jun 17.

  PMID: 21685213 BACKGROUND

• Sicherer SH, Sampson HA. Food allergy. J Allergy Clin Immunol. 2010 Feb;125(2 Suppl 2):S116-25. doi: 10.1016/j.jaci.2009.08.028. Epub 2009 Dec 29.

  PMID: 20042231 BACKGROUND

• Sugunasingha N, Jones FW, Jones CJ. Interventions for caregivers of children with food allergy: A systematic review. Pediatr Allergy Immunol. 2020 Oct;31(7):805-812. doi: 10.1111/pai.13255. Epub 2020 Jun 24.

  PMID: 32311157 BACKGROUND

• Turner 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.

  PMID: 25468198 BACKGROUND

• Valentine AZ, Knibb RC. Exploring quality of life in families of children living with and without a severe food allergy. Appetite. 2011 Oct;57(2):467-74. doi: 10.1016/j.appet.2011.06.007. Epub 2011 Jun 25.

  PMID: 21708202 BACKGROUND

• van Dis EAM, van Veen SC, Hagenaars MA, Batelaan NM, Bockting CLH, van den Heuvel RM, Cuijpers P, Engelhard IM. Long-term Outcomes of Cognitive Behavioral Therapy for Anxiety-Related Disorders: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2020 Mar 1;77(3):265-273. doi: 10.1001/jamapsychiatry.2019.3986.

  PMID: 31758858 BACKGROUND

• Jones CJ, Tallentire H, Edgecumbe R, Sherlock G, Hale L. Online, group, low-intensity psychological intervention for adults, children, and parents with food allergy. Ann Allergy Asthma Immunol. 2024 Oct;133(4):453-461. doi: 10.1016/j.anai.2024.07.025. Epub 2024 Jul 26.

  PMID: 39069154 DERIVED

Related Links

• The Natasha Allergy Research Foundation (2019). The Allergy Explosion. Retrieved from https://www.narf.org.uk/the-allergy-explosion.

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gina Sherlock

  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: March 1, 2021
• Study Start: February 1, 2021
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: July 6, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)