[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587633":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":24,"responsibleParty":36,"collaborators":38,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":18,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":18,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":65,"whyStopped":18,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"University of Surrey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Parent self-help psychological resource","EXPERIMENTAL","A self-help psychological resource will be provided for parents to use with their CYP in the home. Parents can also attend an online peer support information workshop.",[13],"Behavioral: Parent self-help psychological resource",{"label":15,"type":16,"description":17,"interventionNames":18},"Wait list control","NO_INTERVENTION","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 5 months.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","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",[9],[25],{"facility":26,"status":18,"city":27,"state":18,"zip":18,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":18},"Royal Surrey County Hospital","Guildford","United Kingdom","UK",{"type":31,"coordinates":32},"Point",[33,34],-0.57427,51.23536,{"lat":34,"lon":33},{"type":37,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[39],{"name":40,"class":41},"Coeliac UK","UNKNOWN","100587633","supporting-children-and-young-people-to-live-well-with-coeliac-disease-a-rct-100587633",false,"NCT06930924","Supporting Children and Young People to Live Well With Coeliac Disease: A RCT","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","Inclusion Criteria:\n\nCaregiver(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\u002Fassent. 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\n\nExclusion Criteria:\n\nFamilies 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\u002F or online survey.","ALL","7 Years","11 Years",{"count":53,"type":54},350,"ESTIMATED","INTERVENTIONAL",[57],"NA","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.\n\nFor 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.",[60,61],"Coeliac Disease","Celiac Disease in Children",[63,64],"Coeliac disease","celiac disease","NOT_YET_RECRUITING","2025-04-08",{"date":68,"type":69},"2025-04-16","ACTUAL",{"date":71,"type":54},"2025-05-01",{"date":73,"type":54},"2026-03-01",{"name":5,"class":6},1]