Coeliac DiseaseNCT06930924
Supporting Children and Young People to Live Well With Coeliac Disease: A RCT
A study testing Parent self-help psychological resource in people with Coeliac Disease and Celiac Disease in Children, run by University of Surrey at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Coeliac Disease, Celiac Disease in Children
- What is being tested?
- Parent self-help psychological resource
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Coeliac Disease, Celiac Disease in Children
- Being tested
- Parent self-help psychological resource
- Keywords
- Coeliac disease, celiac disease
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent self-help psychological resourceBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parent self-help psychological resource |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1-month, 2-months, 5-months
Secondary outcomes (4)
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.
Measured: Baseline, 1-month, 2-months, 5-months
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.
Measured: Baseline, 1-month, 2-months, 5-months
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.
Measured: Baseline, 1-month, 2-months, 5-months
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.
Measured: Baseline, 1-month, 2-months, 5-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Coeliac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Coeliac UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930924
- Sponsor's protocol ID
- SPON-2024-28
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wood JJ, McLeod BD, Sigman M, Hwang WC, Chu BC. Parenting and childhood anxiety: theory, empirical findings, and future directions. J Child Psychol Psychiatry. 2003 Jan;44(1):134-51. doi: 10.1111/1469-7610.00106.
PubMed 12553416White LE, Bannerman E, Gillett PM. Coeliac disease and the gluten-free diet: a review of the burdens; factors associated with adherence and impact on health-related quality of life, with specific focus on adolescence. J Hum Nutr Diet. 2016 Oct;29(5):593-606. doi: 10.1111/jhn.12375. Epub 2016 May 23.
PubMed 27214084Majewska Z, Dilling-Ostrowska E. [Speech disorders in childhood]. Psychiatr Neurol Med Psychol Beih. 1970;13-14:94-9. German.
PubMed 4143528Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
PubMed 18042300Silvester JA, Weiten D, Graff LA, Walker JR, Duerksen DR. Living gluten-free: adherence, knowledge, lifestyle adaptations and feelings towards a gluten-free diet. J Hum Nutr Diet. 2016 Jun;29(3):374-82. doi: 10.1111/jhn.12316. Epub 2015 Apr 20.
PubMed 25891988Satherley RM, Coburn SS, Germone M. The Impact of Celiac Disease on Caregivers' Well-being: An Integrative Review. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):295-303. doi: 10.1097/MPG.0000000000002572.
PubMed 31789773Russo C, Wolf RL, Leichter HJ, Lee AR, Reilly NR, Zybert P, Green PHR, Lebwohl B. Impact of a Child's Celiac Disease Diagnosis and Management on the Family. Dig Dis Sci. 2020 Oct;65(10):2959-2969. doi: 10.1007/s10620-020-06316-0. Epub 2020 May 15.
PubMed 32415563Guedes NG, Silva LAD, Bessa CC, Santos JCD, Silva VMD, Lopes MVO. Anxiety and depression: a study of psychoaffective, family-related, and daily-life factors in celiac individuals. Rev Bras Enferm. 2020 Sep 21;73Suppl 1(Suppl 1):e20200086. doi: 10.1590/0034-7167-2020-0086. eCollection 2020. English, Portuguese.
PubMed 32965317Jones CJ, Read R, O'Donnell N, Wakelin K, John M, Skene SS, Stewart R, Hale L, Cooke D, Kanumakala S, Satherley RM. PRIORITY Trial: Results from a feasibility randomised controlled trial of a psychoeducational intervention for parents to prevent disordered eating in children and young people with type 1 diabetes. Diabet Med. 2024 Apr;41(4):e15263. doi: 10.1111/dme.15263. Epub 2023 Dec 15.
PubMed 38100228Jones CJ, O'Donnell N, John M, Cooke D, Stewart R, Hale L, Skene SS, Kanumakala S, Harrington M, Satherley RM. PaRent InterventiOn to pRevent dIsordered eating in children with TYpe 1 diabetes (PRIORITY): Study protocol for a feasibility randomised controlled trial. Diabet Med. 2022 Apr;39(4):e14738. doi: 10.1111/dme.14738. Epub 2021 Nov 12.
PubMed 34741779Jordan NE, Li Y, Magrini D, Simpson S, Reilly NR, Defelice AR, Sockolow R, Green PH. Development and validation of a celiac disease quality of life instrument for North American children. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):477-86. doi: 10.1097/MPG.0b013e31829b68a1.
PubMed 23689265Mazzone L, Reale L, Spina M, Guarnera M, Lionetti E, Martorana S, Mazzone D. Compliant gluten-free children with celiac disease: an evaluation of psychological distress. BMC Pediatr. 2011 May 27;11:46. doi: 10.1186/1471-2431-11-46.
PubMed 21619651Olsson C, Lyon P, Hornell A, Ivarsson A, Sydner YM. Food that makes you different: the stigma experienced by adolescents with celiac disease. Qual Health Res. 2009 Jul;19(7):976-84. doi: 10.1177/1049732309338722.
PubMed 19556403Biagi F, Andrealli A, Bianchi PI, Marchese A, Klersy C, Corazza GR. A gluten-free diet score to evaluate dietary compliance in patients with coeliac disease. Br J Nutr. 2009 Sep;102(6):882-7. doi: 10.1017/S0007114509301579. Epub 2009 Mar 31.
PubMed 19331704
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06930924
- Acronym / sponsor ID
- SPON-2024-28
- Conditions
- Coeliac Disease, Celiac Disease in Children
- Keywords
- Coeliac disease, celiac disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Coeliac UK
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Parent self-help psychological resource | Experimental | Behavioral: Parent self-help psychological resourceA 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. |
| 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent self-help psychological resourceA 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 | Behavioural | Parent self-help psychological resource |
Primary outcome
The Pediatric Quality of Life scale (parent-report)
Time frame: Baseline, 1-month, 2-months, 5-months
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.
4 secondary outcomes
Knowledge about the gluten-free diet assessment
Time frame: Baseline, 1-month, 2-months, 5-months
Gluten-free diet adherence (parent-report)
Time frame: Baseline, 1-month, 2-months, 5-months
Gluten-free diet adherence (child-report, Biagi et al., 2009).
Time frame: Baseline, 1-month, 2-months, 5-months
Warwick-Edinburgh Mental Wellbeing scale
Time frame: Baseline, 1-month, 2-months, 5-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Background: PubMed 12553416Wood JJ, McLeod BD, Sigman M, Hwang WC, Chu BC. Parenting and childhood anxiety: theory, empirical findings, and future directions. J Child Psychol Psychiatry. 2003 Jan;44(1):134-51. doi: 10.1111/1469-7610.00106.
- Background: PubMed 27214084White LE, Bannerman E, Gillett PM. Coeliac disease and the gluten-free diet: a review of the burdens; factors associated with adherence and impact on health-related quality of life, with specific focus on adolescence. J Hum Nutr Diet. 2016 Oct;29(5):593-606. doi: 10.1111/jhn.12375. Epub 2016 May 23.
- Background: PubMed 4143528Majewska Z, Dilling-Ostrowska E. [Speech disorders in childhood]. Psychiatr Neurol Med Psychol Beih. 1970;13-14:94-9. German.
- Background: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Background: PubMed 18042300Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
- Background: PubMed 25891988Silvester JA, Weiten D, Graff LA, Walker JR, Duerksen DR. Living gluten-free: adherence, knowledge, lifestyle adaptations and feelings towards a gluten-free diet. J Hum Nutr Diet. 2016 Jun;29(3):374-82. doi: 10.1111/jhn.12316. Epub 2015 Apr 20.
- Background: PubMed 31789773Satherley RM, Coburn SS, Germone M. The Impact of Celiac Disease on Caregivers' Well-being: An Integrative Review. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):295-303. doi: 10.1097/MPG.0000000000002572.
- Background: PubMed 32415563Russo C, Wolf RL, Leichter HJ, Lee AR, Reilly NR, Zybert P, Green PHR, Lebwohl B. Impact of a Child's Celiac Disease Diagnosis and Management on the Family. Dig Dis Sci. 2020 Oct;65(10):2959-2969. doi: 10.1007/s10620-020-06316-0. Epub 2020 May 15.
- Background: PubMed 32965317Guedes NG, Silva LAD, Bessa CC, Santos JCD, Silva VMD, Lopes MVO. Anxiety and depression: a study of psychoaffective, family-related, and daily-life factors in celiac individuals. Rev Bras Enferm. 2020 Sep 21;73Suppl 1(Suppl 1):e20200086. doi: 10.1590/0034-7167-2020-0086. eCollection 2020. English, Portuguese.
- Background: PubMed 38100228Jones CJ, Read R, O'Donnell N, Wakelin K, John M, Skene SS, Stewart R, Hale L, Cooke D, Kanumakala S, Satherley RM. PRIORITY Trial: Results from a feasibility randomised controlled trial of a psychoeducational intervention for parents to prevent disordered eating in children and young people with type 1 diabetes. Diabet Med. 2024 Apr;41(4):e15263. doi: 10.1111/dme.15263. Epub 2023 Dec 15.
- Background: PubMed 34741779Jones CJ, O'Donnell N, John M, Cooke D, Stewart R, Hale L, Skene SS, Kanumakala S, Harrington M, Satherley RM. PaRent InterventiOn to pRevent dIsordered eating in children with TYpe 1 diabetes (PRIORITY): Study protocol for a feasibility randomised controlled trial. Diabet Med. 2022 Apr;39(4):e14738. doi: 10.1111/dme.14738. Epub 2021 Nov 12.
- Background: PubMed 23689265Jordan NE, Li Y, Magrini D, Simpson S, Reilly NR, Defelice AR, Sockolow R, Green PH. Development and validation of a celiac disease quality of life instrument for North American children. J Pediatr Gastroenterol Nutr. 2013 Oct;57(4):477-86. doi: 10.1097/MPG.0b013e31829b68a1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent self-help psychological resource in people with Coeliac Disease and Celiac Disease in Children, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pediatric Quality of Life scale (parent-report) (time frame: Baseline, 1-month, 2-months, 5-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06930924, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.