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Supporting Children and Young People to Live Well With Coeliac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06007898
Recruitment Status : Recruiting
First Posted : August 23, 2023
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
University of Surrey

Study Description
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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.

Condition or disease Intervention/treatment Phase
Celiac Disease Celiac Disease in Children Behavioral: Parent self-help psychological resource Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : May 2, 2024
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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Arm Intervention/treatment
Experimental: Parent self-help psychological resource
A self-help psychological resource will be provided for parents to use with their CYP in the home.
 Behavioral: Parent self-help psychological resource
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.
No Intervention: Wait list control
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.


Outcome Measures
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Primary Outcome Measures :
  1. Warwick-Edinburgh Mental Wellbeing scale [ Time Frame: Baseline, 1-month, 2-months ]

    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 :
  1. Knowledge about the gluten-free diet assessment [ Time Frame: Baseline, 1-month, 2-months ]
    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.

  2. The Pediatric Quality of Life scale (parent-report) [ Time Frame: Baseline, 1-month, 2-months ]
    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.

  3. Gluten-free diet adherence (parent-report) [ Time Frame: Baseline, 1-month, 2-months ]
    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.

  4. The Celiac Disease Quality of Life measure (child-report) [ Time Frame: Baseline, 1-month, 2-months ]
    Child reported measure to assess children's quality of life (optional). Scores range from 0-52, with higher scores indicating greater quality of life.

  5. Gluten-free diet adherence (child-report) Gluten-free diet adherence (child-report, Biagi et al., 2009). [ Time Frame: Baseline, 1-month, 2-months ]
    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.


Other Outcome Measures:
  1. Number of parents invited to the study [ Time Frame: 2-months ]
    Number of parents invited to the study

  2. Number of parents interested in participating in the study [ Time Frame: 2-months ]
    Number of parents interested in participating in the study

  3. Number of parents meeting eligibility criteria [ Time Frame: 2-months ]
    Number of parents meeting eligibility criteria

  4. Number of parents participating in the intervention [ Time Frame: Baseline ]
    Number of parents participating in the intervention

  5. Number of parents recruited to the intervention [ Time Frame: Baseline ]
    Number of parents recruited to the intervention

  6. Number of parents completing the intervention [ Time Frame: 2-months ]
    Number of parents completing the intervention


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06007898


Contacts
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Contact: Rose-Marie Satherley +44 (0)1483 684518 r.satherley@surrey.ac.uk

Locations
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United Kingdom
Bristol Royal Hospital for Children Recruiting
Bristol, United Kingdom
Contact: Sophie Velleman         
Royal Surrey County Hospital Not yet recruiting
Guildford, United Kingdom
Contact: Ozan Hanci         
Oxford Children's Hospital Recruiting
Oxford, United Kingdom
Contact: Annabel David         
Sponsors and Collaborators
University of Surrey
Investigators
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Principal Investigator: Rose-Marie Satherley University of Surrey
More Information
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Publications:

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Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT06007898    
Other Study ID Numbers: SPON-023-17
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Surrey:
celiac
wellbeing
quality of life
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases