Supporting Children and Young People to Live Well with Coeliac Disease

NCT06007898 | Completed

• 1 other identifier: SPON-023-17
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

Brief Summary

Managing a strict gluten-free diet is crucial for children and young people with coeliac disease. However, this can have adverse effects on psychological well-being and quality of life. Despite appeals from families, clinicians, and researchers, psychological support is not routinely provided to these families. This project aims to adapt existing self-help psychological resources used for food allergy, gastrointestinal disease, and type one diabetes to cater to families dealing with coeliac disease. The process involves collaboration with families and clinicians to modify these resources. Subsequently, a feasibility randomised controlled trial will be conducted to assess the viability and acceptability of these resources. In the trial, 50 families will complete well-being and quality of life questionnaires, along with assessments of their child's gluten-free dietary management. Families will be divided into groups receiving the psychological resources either immediately or after a two-month delay. Follow-up questionnaires will be administered at one and two months for all families, regardless of intervention access. Feedback on the resources and research participation will be gathered. The expectation is that these self-help psychological resources for parents will enhance gluten-free diet management, quality of life for coeliac children and young people, and well-being for parents.

Conditions

Celiac Disease; Celiac Disease in Children

Keywords

celiac; wellbeing; quality of life

Outcome Measures

Primary Outcomes (1)

• Warwick-Edinburgh Mental Wellbeing scale

  The scale has 14 items assessing various aspects of mental wellbeing. Scores range from 14 to 70, reflecting greater mental wellbeing with higher scores. The scale has 14 items assessing various aspects of mental wellbeing. Scores range from 14 to 70, reflecting greater mental wellbeing with higher scores.

  Baseline, 1-month, 2-months

Secondary Outcomes (5)

• Knowledge about the gluten-free diet assessment

  Baseline, 1-month, 2-months

• The Pediatric Quality of Life scale (parent-report)

  Baseline, 1-month, 2-months

• Gluten-free diet adherence (parent-report)

  Baseline, 1-month, 2-months

• The Celiac Disease Quality of Life measure (child-report)

  Baseline, 1-month, 2-months

• Gluten-free diet adherence (child-report) Gluten-free diet adherence (child-report, Biagi et al., 2009).

  Baseline, 1-month, 2-months

Other Outcomes (6)

• Number of parents invited to the study

  2-months

• Number of parents interested in participating in the study

  2-months

• Number of parents meeting eligibility criteria

  2-months

Study Arms (2)

Parent self-help psychological resource

EXPERIMENTAL

A self-help psychological resource will be provided for parents to use with their CYP in the home.

Behavioral: Parent self-help psychological resource

Wait list control

NO INTERVENTION

Parents randomised to the control arm will be put on the waiting list (wait-list controls) to receive the group intervention after they have completed their final follow-up at 2 months.

Interventions

Parent self-help psychological resource BEHAVIORAL

A self-help psychological resource designed alongside families and clinicians, to be delivered to parents of CYP with coeliac disease. The resource will focus on providing psychoeducation on the gluten-free diet, concerns around dietary management, using family's strengths to support dietary management, managing outside the home, and transition to independent management of the gluten-free diet.

Parent self-help psychological resource

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Caregiver(s) with a CYP between 8-11 years of age who report a diagnosis of coeliac disease
• Willingness to take part in a self-help psychological intervention
• Participant must have the ability to provide informed consent/assent. Caregiver(s) who consent to the study will still be able to take part, even if their CYP does not provide assent to complete outcome measures

You may not qualify if:

• Families participating in another intervention-based research will not be eligible
• Participant identified by clinical team as not appropriate (e.g. undergoing treatment for other complex difficulties)
• English proficiency unsuitable for participation in self-help psychological intervention and/ or online survey.

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (3)

Bristol Royal Hospital for Children

Bristol, United Kingdom

Location

Royal Surrey County Hospital

Guildford, United Kingdom

Location

Oxford Children's Hospital

Oxford, United Kingdom

Location

Related Publications (14)

• Biagi F, Andrealli A, Bianchi PI, Marchese A, Klersy C, Corazza GR. A gluten-free diet score to evaluate dietary compliance in patients with coeliac disease. Br J Nutr. 2009 Sep;102(6):882-7. doi: 10.1017/S0007114509301579. Epub 2009 Mar 31.

  PMID: 19331704 BACKGROUND

• Guedes NG, Silva LAD, Bessa CC, Santos JCD, Silva VMD, Lopes MVO. Anxiety and depression: a study of psychoaffective, family-related, and daily-life factors in celiac individuals. Rev Bras Enferm. 2020 Sep 21;73Suppl 1(Suppl 1):e20200086. doi: 10.1590/0034-7167-2020-0086. eCollection 2020. English, Portuguese.

  PMID: 32965317 BACKGROUND

• Jones CJ, O'Donnell N, John M, Cooke D, Stewart R, Hale L, Skene SS, Kanumakala S, Harrington M, Satherley RM. PaRent InterventiOn to pRevent dIsordered eating in children with TYpe 1 diabetes (PRIORITY): Study protocol for a feasibility randomised controlled trial. Diabet Med. 2022 Apr;39(4):e14738. doi: 10.1111/dme.14738. Epub 2021 Nov 12.

  PMID: 34741779 BACKGROUND

• Jordan NE, Li Y, Magrini D, Simpson S, Reilly NR, Defelice AR, Sockolow R, Green PH. Development and validation of a celiac disease quality of life instrument for North American children. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):477-86. doi: 10.1097/MPG.0b013e31829b68a1.

  PMID: 23689265 BACKGROUND

• Mazzone L, Reale L, Spina M, Guarnera M, Lionetti E, Martorana S, Mazzone D. Compliant gluten-free children with celiac disease: an evaluation of psychological distress. BMC Pediatr. 2011 May 27;11:46. doi: 10.1186/1471-2431-11-46.

  PMID: 21619651 BACKGROUND

• Olsson C, Lyon P, Hornell A, Ivarsson A, Sydner YM. Food that makes you different: the stigma experienced by adolescents with celiac disease. Qual Health Res. 2009 Jul;19(7):976-84. doi: 10.1177/1049732309338722.

  PMID: 19556403 BACKGROUND

• Russo C, Wolf RL, Leichter HJ, Lee AR, Reilly NR, Zybert P, Green PHR, Lebwohl B. Impact of a Child's Celiac Disease Diagnosis and Management on the Family. Dig Dis Sci. 2020 Oct;65(10):2959-2969. doi: 10.1007/s10620-020-06316-0. Epub 2020 May 15.

  PMID: 32415563 BACKGROUND

• Satherley RM, Coburn SS, Germone M. The Impact of Celiac Disease on Caregivers' Well-being: An Integrative Review. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):295-303. doi: 10.1097/MPG.0000000000002572.

  PMID: 31789773 BACKGROUND

• Silvester JA, Weiten D, Graff LA, Walker JR, Duerksen DR. Living gluten-free: adherence, knowledge, lifestyle adaptations and feelings towards a gluten-free diet. J Hum Nutr Diet. 2016 Jun;29(3):374-82. doi: 10.1111/jhn.12316. Epub 2015 Apr 20.

  PMID: 25891988 BACKGROUND

• Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

  PMID: 18042300 BACKGROUND

• Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.

  PMID: 11468499 BACKGROUND

• Vreeken-Ross SC, Cartwright-Hatton S, Harris SA, Hanna P, Jones CJ. Feasibility of an online CBT group intervention for parents of children with food allergy. Clin Exp Allergy. 2022 Jan;52(1):171-175. doi: 10.1111/cea.13970. Epub 2021 Jun 26. No abstract available.

  PMID: 34143528 BACKGROUND

• White LE, Bannerman E, Gillett PM. Coeliac disease and the gluten-free diet: a review of the burdens; factors associated with adherence and impact on health-related quality of life, with specific focus on adolescence. J Hum Nutr Diet. 2016 Oct;29(5):593-606. doi: 10.1111/jhn.12375. Epub 2016 May 23.

  PMID: 27214084 BACKGROUND

• Wood JJ, McLeod BD, Sigman M, Hwang WC, Chu BC. Parenting and childhood anxiety: theory, empirical findings, and future directions. J Child Psychol Psychiatry. 2003 Jan;44(1):134-51. doi: 10.1111/1469-7610.00106.

  PMID: 12553416 BACKGROUND

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rose-Marie Satherley

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 23, 2023
• Study Start: May 2, 2024
• Primary Completion: October 9, 2024
• Study Completion: October 9, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)