xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06007898</url>
    </required_header>
    <id_info>
      <org_study_id>SPON-023-17</org_study_id>
      <nct_id>NCT06007898</nct_id>
    </id_info>
    <brief_title>Supporting Children and Young People to Live Well With Coeliac Disease</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Surrey</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Surrey</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Managing a strict gluten-free diet is crucial for children and young people with coeliac&#xD;
        disease. However, this can have adverse effects on psychological well-being and quality of&#xD;
        life. Despite appeals from families, clinicians, and researchers, psychological support is&#xD;
        not routinely provided to these families. This project aims to adapt existing self-help&#xD;
        psychological resources used for food allergy, gastrointestinal disease, and type one&#xD;
        diabetes to cater to families dealing with coeliac disease. The process involves&#xD;
        collaboration with families and clinicians to modify these resources. Subsequently, a&#xD;
        feasibility randomised controlled trial will be conducted to assess the viability and&#xD;
        acceptability of these resources. In the trial, 50 families will complete well-being and&#xD;
        quality of life questionnaires, along with assessments of their child's gluten-free dietary&#xD;
        management. Families will be divided into groups receiving the psychological resources either&#xD;
        immediately or after a two-month delay. Follow-up questionnaires will be administered at one&#xD;
        and two months for all families, regardless of intervention access. Feedback on the resources&#xD;
        and research participation will be gathered. The expectation is that these self-help&#xD;
        psychological resources for parents will enhance gluten-free diet management, quality of life&#xD;
        for coeliac children and young people, and well-being for parents.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Coeliac disease is a common autoimmune condition in children, estimated to affect 1 in 100 in&#xD;
        the UK. Coeliac disease can occur at any age and is treated with a lifelong gluten-free diet.&#xD;
        When someone with coeliac disease eats gluten (a protein found in wheat, barley and rye),&#xD;
        their immune system attacks itself and causes damage to the gut. If left undiagnosed and&#xD;
        untreated long term, the disease can cause complications like growth problems, delayed&#xD;
        puberty, tooth enamel defects, iron deficiency anaemia, chronic fatigue and, over time,&#xD;
        osteoporosis. The good news is, these potential complications can be avoided with early&#xD;
        diagnosis and treatment.&#xD;
  &#xD;
        While strict management of the gluten-free diet has been linked to improvements in intestinal&#xD;
        damage and quality of life, the relentless behavioural and social demands of detecting gluten&#xD;
        is challenging. Often, families report concerns around attending family gatherings, school&#xD;
        trips, and eating out at restaurants due to the potential for accidental gluten consumption.&#xD;
        To manage these concerns, some families avoid social events entirely, which can affect school&#xD;
        attendance and participation in normal childhood activities such as birthday parties and&#xD;
        sleepovers. Children and young people (CYP) with coeliac disease have described feeling like&#xD;
        a &quot;nuisance&quot; and may experience social stigma associated with their need to eat different&#xD;
        food, frustration and isolation, and a higher probability of developing mental health&#xD;
        conditions, such as depression, anxiety, or eating disorders.&#xD;
  &#xD;
        A large body of research suggests that exposure to parental anxiety increases the risk of&#xD;
        similar problems in CYP. CYP can learn that certain situations lead their parents to feel&#xD;
        anxious, which may lead to them feeling threatened, and cope (usually by avoidance) in a&#xD;
        similar manner. The same appears true for families with coeliac disease, where caregiver(s)&#xD;
        with high levels of anxiety, have CYP with higher levels of anxiety. Whilst the gluten-free&#xD;
        diet is essential for the management of coeliac disease, it is not enough to only address&#xD;
        foods that must that be avoided in coeliac disease. Support must also address how to navigate&#xD;
        a gluten-free diet that does not require social isolation and over-restriction. For CYP with&#xD;
        coeliac disease, management of the gluten-free diet often relies on the caregiver(s), and so,&#xD;
        intervention components must support the whole family system.&#xD;
  &#xD;
        Self-help psychological interventions (interactive websites and books) for families of CYP&#xD;
        with food allergy and type one diabetes already exist. These interventions appear impactful&#xD;
        when embedded alongside routine care for CYP with food allergy, and looks promising for CYP&#xD;
        with type one diabetes. These findings suggest that these psychological interventions reduce&#xD;
        anxiety and increase wellbeing in caregiver(s), as well as their CYP. In line with family&#xD;
        desires and health system policy, this project will adapt these existing self-help&#xD;
        psychological interventions to support families of CYP with coeliac disease, and test the&#xD;
        impact on caregiver(s) wellbeing, and CYP gluten-free diet management and wellbeing.&#xD;
  &#xD;
        The anticipation is that the development and delivery of effective self-help psychological&#xD;
        interventions for caregiver(s) of CYP with coeliac disease will support appropriate&#xD;
        management of the gluten-free diet, alongside psychological wellbeing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Warwick-Edinburgh Mental Wellbeing scale</measure>
      <time_frame>Baseline, 1-month, 2-months</time_frame>
      <description>The scale has 14 items assessing various aspects of mental wellbeing. Scores range from 14 to 70, reflecting greater mental wellbeing with higher scores.&#xD;
  The scale has 14 items assessing various aspects of mental wellbeing. Scores range from 14 to 70, reflecting greater mental wellbeing with higher scores.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Knowledge about the gluten-free diet assessment</measure>
      <time_frame>Baseline, 1-month, 2-months</time_frame>
      <description>A bespoke measure developed for this 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Pediatric Quality of Life scale (parent-report)</measure>
      <time_frame>Baseline, 1-month, 2-months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gluten-free diet adherence (parent-report)</measure>
      <time_frame>Baseline, 1-month, 2-months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Celiac Disease Quality of Life measure (child-report)</measure>
      <time_frame>Baseline, 1-month, 2-months</time_frame>
      <description>Child reported measure to assess children's quality of life (optional). Scores range from 0-52, with higher scores indicating greater quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gluten-free diet adherence (child-report) Gluten-free diet adherence (child-report, Biagi et al., 2009).</measure>
      <time_frame>Baseline, 1-month, 2-months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Number of parents invited to the study</measure>
      <time_frame>2-months</time_frame>
      <description>Number of parents invited to the study</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of parents interested in participating in the study</measure>
      <time_frame>2-months</time_frame>
      <description>Number of parents interested in participating in the study</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of parents meeting eligibility criteria</measure>
      <time_frame>2-months</time_frame>
      <description>Number of parents meeting eligibility criteria</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of parents participating in the intervention</measure>
      <time_frame>Baseline</time_frame>
      <description>Number of parents participating in the intervention</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of parents recruited to the intervention</measure>
      <time_frame>Baseline</time_frame>
      <description>Number of parents recruited to the intervention</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of parents completing the intervention</measure>
      <time_frame>2-months</time_frame>
      <description>Number of parents completing the intervention</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Celiac Disease</condition>
    <condition>Celiac Disease in Children</condition>
    <arm_group>
      <arm_group_label>Parent self-help psychological resource</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A self-help psychological resource will be provided for parents to use with their CYP in the home.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wait list control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Parent self-help psychological resource</intervention_name>
      <description>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.</description>
      <arm_group_label>Parent self-help psychological resource</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Caregiver(s) with a CYP between 8-11 years of age who report a diagnosis of coeliac&#xD;
               disease&#xD;
  &#xD;
            -  Willingness to take part in a self-help psychological intervention&#xD;
  &#xD;
            -  Participant must have the ability to provide informed consent/assent. Caregiver(s) who&#xD;
               consent to the study will still be able to take part, even if their CYP does not&#xD;
               provide assent to complete outcome measures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Families participating in another intervention-based research will not be eligible&#xD;
  &#xD;
            -  Participant identified by clinical team as not appropriate (e.g. undergoing treatment&#xD;
               for other complex difficulties)&#xD;
  &#xD;
            -  English proficiency unsuitable for participation in self-help psychological&#xD;
               intervention and/ or online survey.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>11 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rose-Marie Satherley</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Surrey</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rose-Marie Satherley</last_name>
      <phone>+44 (0)1483 684518</phone>
      <email>r.satherley@surrey.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bristol Royal Hospital for Children</name>
        <address>
          <city>Bristol</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Sophie Velleman</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Royal Surrey County Hospital</name>
        <address>
          <city>Guildford</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Ozan Hanci</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Oxford Children's Hospital</name>
        <address>
          <city>Oxford</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <contact>
        <last_name>Annabel David</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <reference>
      <citation>Biagi 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.</citation>
      <PMID>19331704</PMID>
    </reference>
    <reference>
      <citation>Guedes 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.</citation>
      <PMID>32965317</PMID>
    </reference>
    <reference>
      <citation>Jones 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.</citation>
      <PMID>34741779</PMID>
    </reference>
    <reference>
      <citation>Jordan 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.</citation>
      <PMID>23689265</PMID>
    </reference>
    <reference>
      <citation>Mazzone 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.</citation>
      <PMID>21619651</PMID>
    </reference>
    <reference>
      <citation>Olsson 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.</citation>
      <PMID>19556403</PMID>
    </reference>
    <reference>
      <citation>Russo 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.</citation>
      <PMID>32415563</PMID>
    </reference>
    <reference>
      <citation>Satherley 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.</citation>
      <PMID>31789773</PMID>
    </reference>
    <reference>
      <citation>Silvester 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.</citation>
      <PMID>25891988</PMID>
    </reference>
    <reference>
      <citation>Tennant 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.</citation>
      <PMID>18042300</PMID>
    </reference>
    <reference>
      <citation>Varni 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.</citation>
      <PMID>11468499</PMID>
    </reference>
    <reference>
      <citation>Vreeken-Ross SC, Cartwright-Hatton S, Harris SA, Hanna P, Jones CJ. Feasibility of an online CBT group intervention for parents of children with food allergy. Clin Exp Allergy. 2022 Jan;52(1):171-175. doi: 10.1111/cea.13970. Epub 2021 Jun 26. No abstract available.</citation>
      <PMID>34143528</PMID>
    </reference>
    <reference>
      <citation>White 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.</citation>
      <PMID>27214084</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>12553416</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>celiac</keyword>
    <keyword>wellbeing</keyword>
    <keyword>quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Celiac Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06007898
  org study id: SPON-023-17
  nct id: NCT06007898
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  
        Self-help psychological interventions (interactive websites and books) for families of CYP
        with food allergy and type one diabetes already exist. These interventions appear impactful
        when embedded alongside routine care for CYP with food allergy, and looks promising for CYP
        with type one diabetes. These findings suggest that these psychological interventions reduce
        anxiety and increase wellbeing in caregiver(s), as well as their CYP. In line with family
        desires and health system policy, this project will adapt these existing self-help
        psychological interventions to support families of CYP with coeliac disease, and test the
        impact on caregiver(s) wellbeing, and CYP gluten-free diet management and wellbeing.
  
        The anticipation is that the development and delivery of effective self-help psychological
        interventions for caregiver(s) of CYP with coeliac disease will support appropriate
        management of the gluten-free diet, alongside psychological wellbeing.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Warwick-Edinburgh Mental Wellbeing scale
  time frame: Baseline, 1-month, 2-months
  description: The scale has 14 items assessing various aspects of mental wellbeing. Scores range from 14 to 70, reflecting greater mental wellbeing with higher scores.
  The scale has 14 items assessing various aspects of mental wellbeing. Scores range from 14 to 70, reflecting greater mental wellbeing with higher scores.
  measure: Knowledge about the gluten-free diet assessment
  time frame: Baseline, 1-month, 2-months
  description: A bespoke measure developed for this 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.
  measure: The Pediatric Quality of Life scale (parent-report)
  time frame: Baseline, 1-month, 2-months
  description: 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.
  measure: Gluten-free diet adherence (parent-report)
  time frame: Baseline, 1-month, 2-months
  description: 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.
  measure: The Celiac Disease Quality of Life measure (child-report)
  time frame: Baseline, 1-month, 2-months
  description: Child reported measure to assess children's quality of life (optional). Scores range from 0-52, with higher scores indicating greater quality of life.
  measure: Gluten-free diet adherence (child-report) Gluten-free diet adherence (child-report, Biagi et al., 2009).
  time frame: Baseline, 1-month, 2-months
  description: 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.
  measure: Number of parents invited to the study
  time frame: 2-months
  description: Number of parents invited to the study
  measure: Number of parents interested in participating in the study
  time frame: 2-months
  description: Number of parents interested in participating in the study
  measure: Number of parents meeting eligibility criteria
  time frame: 2-months
  description: Number of parents meeting eligibility criteria
  measure: Number of parents participating in the intervention
  time frame: Baseline
  description: Number of parents participating in the intervention
  measure: Number of parents recruited to the intervention
  time frame: Baseline
  description: Number of parents recruited to the intervention
  measure: Number of parents completing the intervention
  time frame: 2-months
  description: Number of parents completing the intervention
  arm group label: Parent self-help psychological resource
  arm group type: Experimental
  description: A self-help psychological resource will be provided for parents to use with their CYP in the home.
  arm group label: Wait list control
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Parent self-help psychological resource
  description: 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.
  arm group label: Parent self-help psychological resource
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 11 Years
  healthy volunteers: No
  last name: Rose-Marie Satherley
  role: Principal Investigator
  affiliation: University of Surrey
  last name: Rose-Marie Satherley
  phone: +44 (0)1483 684518
  email: r.satherley@surrey.ac.uk
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: United Kingdom
  citation: Biagi 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.
  PMID: 19331704
  citation: Guedes 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.
  PMID: 32965317
  citation: Jones 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.
  PMID: 34741779
  citation: Jordan 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.
  PMID: 23689265
  citation: Mazzone 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.
  PMID: 21619651
  citation: Olsson 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.
  PMID: 19556403
  citation: Russo 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.
  PMID: 32415563
  citation: Satherley 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.
  PMID: 31789773
  citation: Silvester 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.
  PMID: 25891988
  citation: Tennant 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.
  PMID: 18042300
  citation: Varni 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.
  PMID: 11468499
  citation: Vreeken-Ross SC, Cartwright-Hatton S, Harris SA, Hanna P, Jones CJ. Feasibility of an online CBT group intervention for parents of children with food allergy. Clin Exp Allergy. 2022 Jan;52(1):171-175. doi: 10.1111/cea.13970. Epub 2021 Jun 26. No abstract available.
  PMID: 34143528
  citation: White 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.
  PMID: 27214084
  citation: 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.
  PMID: 12553416
  responsible party type: Sponsor
  mesh term: Celiac Disease
  sharing ipd: No