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Supporting Children and Young People to Live Well With Coeliac Disease: A RCT

NCT06930924 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-04-16

No results posted yet for this study

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.

Conditions

  • Coeliac Disease
  • Celiac Disease in Children

Interventions

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. Parents will also attend a 60-minute online peer support and information workshop

Sponsors & Collaborators

  • Coeliac UK

    collaborator UNKNOWN

  • University of Surrey

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-02-01
Completion
2026-03-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06930924 on ClinicalTrials.gov