About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Parent self-help psychological resource
BehavioralA 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. Parents will also attend a 60-minute online peer support and information workshop
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Knowledge about the gluten-free diet assessment
A bespoke measure developed for this project and the feasibility 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.
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.
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.
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.
Sponsors and contacts
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University of Surrey
Lead sponsor
Coeliac UK
Collaborator
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