Clinical trial NCT06930924: Supporting Children and Young People to Live Well With Coeliac Disease: A RCT
Official title: Evaluation of a Self-help Psychological Intervention to Support Gluten-free Diet Management, Psychological Wellbeing and Quality-of-life in Children and Young People (Aged 7-11) With Coeliac Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coeliac Disease
Celiac Disease in Children
Keywords: Coeliac disease
celiac disease
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: Coeliac UK
First posted: 2025-04-16
Enrollment: 350
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

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. A feasibility project (NCT06007898) adapted existing self-help psychological resources used for food allergy, gastrointestinal disease, and type one diabetes to cater to families dealing with coeliac disease. This feasibility randomised controlled trial was conducted with 100 families and highlighted the viability and acceptability of this self-help resource. This pilot study was conducted in consultation with caregiver(s), clinicians, and CYP living with coeliac disease. These consultations confirmed a lack of support in this area and the enthusiasm for self-help psychological interventions. We will now run a full randomised controlled trial to evaluate the effectiveness of the intervention for caregiver(s) of CYP with coeliac disease in supporting the appropriate management of the gluten-free diet, alongside psychological wellbeing.

For this trial, 172 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 five-month delay. Follow-up questionnaires will be administered at one, two, and five 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.

Our research team have already developed self-help psychological interventions (interactive websites and books) for families of CYP with food allergy and type one diabetes. We have demonstrated the impact of embedding these interventions alongside routine care for CYP with food allergy, and we are currently testing this approach in type one diabetes. Our findings suggest that these interventions reduce anxiety and increase wellbeing in caregiver(s), as well as their CYP.

We have also completed a pilot RCT of a self-help psychological intervention for families of CYP with coeliac disease (publication in preparation). This pilot study was conducted in consultation with caregiver(s), clinicians, and CYP living with coeliac disease. These consultations confirmed a lack of support in this area and the enthusiasm for self-help psychological interventions. This enthusiasm was reflected in the high participant demand and intervention engagement observed during the pilot study, along with qualitative feedback from families and the NHS Long Term Plan, indicates that self-help psychological interventions for CD are warranted. We will now run a full randomised controlled trial to evaluate the effectiveness of our intervention for caregiver(s) of CYP with coeliac disease in supporting the appropriate management of the gluten-free diet, alongside psychological wellbeing.

Eligibility criteria: Inclusion Criteria:

Caregiver(s) with a CYP between 7-11 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.

Primary outcomes:
measure: The Pediatric Quality of Life scale (parent-report)
timeFrame: Baseline, 1-month, 2-months, 5-months
Secondary outcomes:
measure: Knowledge about the gluten-free diet assessment
timeFrame: Baseline, 1-month, 2-months, 5-months
measure: Gluten-free diet adherence (parent-report)
timeFrame: Baseline, 1-month, 2-months, 5-months
measure: Gluten-free diet adherence (child-report, Biagi et al., 2009).
timeFrame: Baseline, 1-month, 2-months, 5-months
measure: Warwick-Edinburgh Mental Wellbeing scale
timeFrame: Baseline, 1-month, 2-months, 5-months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
Study officials:
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