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Supporting Children and Young People to Live Well With Coeliac Disease

Primary Purpose

Celiac Disease, Celiac Disease in Children

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Parent self-help psychological resource
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Celiac Disease focused on measuring celiac, wellbeing, quality of life

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Bristol Royal Hospital for Children
  • Royal Surrey County Hospital
  • Oxford Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parent self-help psychological resource

Wait list control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Knowledge about the gluten-free diet assessment
A bespoke measure developed for this project, in consultation with people with coeliac disease and dietitians, to assess parent knowledge of the gluten-free diet. Scores range from 0-12, with higher scores indicating greater knowledge.
The Pediatric Quality of Life scale (parent-report)
Parent reported measure to assess children's quality of life. Scores are converted to a 0 to 100 scale, with higher scores indicating better quality of life.
Gluten-free diet adherence (parent-report)
Parent reported measure to assess children's gluten-free diet adherence, consisting of five levels (0-4). Levels 0 or 1 indicate poor diet adherence, 2 indicates moderate adherence, and 3-4 indicates strict adherence.
The Celiac Disease Quality of Life measure (child-report)
Child reported measure to assess children's quality of life (optional). Scores range from 0-52, with higher scores indicating greater quality of life.
Gluten-free diet adherence (child-report) Gluten-free diet adherence (child-report, Biagi et al., 2009).
Child reported measure to assess children's gluten-free diet adherence (optional) consisting of five levels (0-4). Levels 0 or 1 indicate poor diet adherence, 2 indicates moderate adherence, and 3-4 indicates strict adherence.

Full Information

First Posted
August 8, 2023
Last Updated
August 24, 2023
Sponsor
University of Surrey
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1. Study Identification

Unique Protocol Identification Number
NCT06007898
Brief Title
Supporting Children and Young People to Live Well With Coeliac Disease
Official Title
Development and Feasibility of a Self-help Psychological Intervention to Support Gluten-free Diet Management, Psychological Wellbeing and Quality-of-life in Children and Young People With Coeliac Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Coeliac disease is a common autoimmune condition in children, estimated to affect 1 in 100 in the UK. Coeliac disease can occur at any age and is treated with a lifelong gluten-free diet. When someone with coeliac disease eats gluten (a protein found in wheat, barley and rye), their immune system attacks itself and causes damage to the gut. If left undiagnosed and untreated long term, the disease can cause complications like growth problems, delayed puberty, tooth enamel defects, iron deficiency anaemia, chronic fatigue and, over time, osteoporosis. The good news is, these potential complications can be avoided with early diagnosis and treatment. While strict management of the gluten-free diet has been linked to improvements in intestinal damage and quality of life, the relentless behavioural and social demands of detecting gluten is challenging. Often, families report concerns around attending family gatherings, school trips, and eating out at restaurants due to the potential for accidental gluten consumption. To manage these concerns, some families avoid social events entirely, which can affect school attendance and participation in normal childhood activities such as birthday parties and sleepovers. Children and young people (CYP) with coeliac disease have described feeling like a "nuisance" and may experience social stigma associated with their need to eat different food, frustration and isolation, and a higher probability of developing mental health conditions, such as depression, anxiety, or eating disorders. A large body of research suggests that exposure to parental anxiety increases the risk of similar problems in CYP. CYP can learn that certain situations lead their parents to feel anxious, which may lead to them feeling threatened, and cope (usually by avoidance) in a similar manner. The same appears true for families with coeliac disease, where caregiver(s) with high levels of anxiety, have CYP with higher levels of anxiety. Whilst the gluten-free diet is essential for the management of coeliac disease, it is not enough to only address foods that must that be avoided in coeliac disease. Support must also address how to navigate a gluten-free diet that does not require social isolation and over-restriction. For CYP with coeliac disease, management of the gluten-free diet often relies on the caregiver(s), and so, intervention components must support the whole family system. Self-help psychological interventions (interactive websites and books) for families of CYP with food allergy and type one diabetes already exist. These interventions appear impactful when embedded alongside routine care for CYP with food allergy, and looks promising for CYP with type one diabetes. These findings suggest that these psychological interventions reduce anxiety and increase wellbeing in caregiver(s), as well as their CYP. In line with family desires and health system policy, this project will adapt these existing self-help psychological interventions to support families of CYP with coeliac disease, and test the impact on caregiver(s) wellbeing, and CYP gluten-free diet management and wellbeing. The anticipation is that the development and delivery of effective self-help psychological interventions for caregiver(s) of CYP with coeliac disease will support appropriate management of the gluten-free diet, alongside psychological wellbeing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease, Celiac Disease in Children
Keywords
celiac, wellbeing, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parent self-help psychological resource
Arm Type
Experimental
Arm Description
A self-help psychological resource will be provided for parents to use with their CYP in the home.
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent self-help psychological resource
Intervention Description
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.
Primary Outcome Measure Information:
Title
Warwick-Edinburgh Mental Wellbeing scale
Description
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.
Time Frame
Baseline, 1-month, 2-months
Secondary Outcome Measure Information:
Title
Knowledge about the gluten-free diet assessment
Description
A bespoke measure developed for this project, in consultation with people with coeliac disease and dietitians, to assess parent knowledge of the gluten-free diet. Scores range from 0-12, with higher scores indicating greater knowledge.
Time Frame
Baseline, 1-month, 2-months
Title
The Pediatric Quality of Life scale (parent-report)
Description
Parent reported measure to assess children's quality of life. Scores are converted to a 0 to 100 scale, with higher scores indicating better quality of life.
Time Frame
Baseline, 1-month, 2-months
Title
Gluten-free diet adherence (parent-report)
Description
Parent reported measure to assess children's gluten-free diet adherence, consisting of five levels (0-4). Levels 0 or 1 indicate poor diet adherence, 2 indicates moderate adherence, and 3-4 indicates strict adherence.
Time Frame
Baseline, 1-month, 2-months
Title
The Celiac Disease Quality of Life measure (child-report)
Description
Child reported measure to assess children's quality of life (optional). Scores range from 0-52, with higher scores indicating greater quality of life.
Time Frame
Baseline, 1-month, 2-months
Title
Gluten-free diet adherence (child-report) Gluten-free diet adherence (child-report, Biagi et al., 2009).
Description
Child reported measure to assess children's gluten-free diet adherence (optional) consisting of five levels (0-4). Levels 0 or 1 indicate poor diet adherence, 2 indicates moderate adherence, and 3-4 indicates strict adherence.
Time Frame
Baseline, 1-month, 2-months
Other Pre-specified Outcome Measures:
Title
Number of parents invited to the study
Description
Number of parents invited to the study
Time Frame
2-months
Title
Number of parents interested in participating in the study
Description
Number of parents interested in participating in the study
Time Frame
2-months
Title
Number of parents meeting eligibility criteria
Description
Number of parents meeting eligibility criteria
Time Frame
2-months
Title
Number of parents participating in the intervention
Description
Number of parents participating in the intervention
Time Frame
Baseline
Title
Number of parents recruited to the intervention
Description
Number of parents recruited to the intervention
Time Frame
Baseline
Title
Number of parents completing the intervention
Description
Number of parents completing the intervention
Time Frame
2-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rose-Marie Satherley
Phone
+44 (0)1483 684518
Email
r.satherley@surrey.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rose-Marie Satherley
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bristol Royal Hospital for Children
City
Bristol
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Velleman
Facility Name
Royal Surrey County Hospital
City
Guildford
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozan Hanci
Facility Name
Oxford Children's Hospital
City
Oxford
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annabel David

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19331704
Citation
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Results Reference
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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.
Results Reference
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34741779
Citation
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.
Results Reference
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Citation
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Citation
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Supporting Children and Young People to Live Well With Coeliac Disease

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