Supporting Children and Young People to Live Well with Coeliac Disease
Key facts
- Who runs it
- University of Surrey
- Where
- United Kingdom3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 95 people enrolled
- Started
- 2 May 2024
- Ended
- 9 Oct 2024
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Parent self-help psychological resource
- Record updated
- 16 December 2024
Who can take part
- Age
- 8 years to 11 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Parent self-help psychological resourceTreatment being tested
A self-help psychological resource will be provided for parents to use with their CYP in the home.
- Wait list controlNo study treatment, for comparison
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 16 December 2024