Clinical Trials Logo

Clinical Trial Summary

Celiac disease (CD) is a chronic autoimmune condition whose only currently available treatment is a strict, burdensome gluten-free diet (GFD). The current proposal uses a theory-driven empirical approach for optimizing the GFD for teens and their parents by targeting knowledge, behavior, and coping skills through educational and cognitive-behavioral techniques. Integration with telehealth and SMS (short message service; "text") technology for delivering the intervention has the potential to reduce barriers to specialized treatment at both early and later stages of implementation. The proposed research will refine and test a behavioral intervention for teens with CD and their parents using an iterative stakeholder-centered design. It will consist of a small pilot randomized control trial (RCT) (n=60 dyads). Proof of concept testing will examine intervention feasibility, acceptability, impact, and lead to further refinements based on feedback. The RCT will examine the preliminary efficacy of the intervention and its impact on quality of life and GFD management by targeting self-efficacy, illness identity, and food-related activities. This work has the potential to make a lasting impact on the standards of care and available treatments to optimize CD management in youth and their families.


Clinical Trial Description

Celiac Disease (CD) is an increasingly common disease with significant morbidities if treatment is not achieved. The incidence and prevalence of CD has been increasing in children and teens over the past 15 years in the United States, with prevalence rates nearly tripling from approximately one in 133 to one in fifty children, according to regional population cohort studies. Untreated CD is associated with risks for non-Hodgkin's lymphoma, intestinal cancers, inflammatory bowel disease, diabetes mellitus, and a twofold increase in risks for mortality. The only treatment for CD is a strict Gluten-Free Diet (GFD), which is complex, expensive, tiring, and anxiety-provoking. CD is also associated with impaired quality of life (QOL) and burdensome treatment. Impaired QOL, including poor psychological well-being and functioning, occurs more frequently in CD compared with the general population, likely due to physiological vulnerabilities associated with CD as well as the social impact of the GFD. Teens with CD may experience psychosocial difficulties associated with the GFD due to negative perceptions about reasons for requesting gluten-free foods. Therefore, despite advances in palatable gluten-free products and their availability, youth with CD continue to struggle with GFD management and face new sources of misinformation and misperceptions by others. Like their children, parents are also at risk for poorer QOL resulting from the challenges associated with the treatment of CD in their children. Parents may experience social isolation and stress associated with caring for a child with CD, which can impact family dynamics and the daily tasks of following the GFD. Caregivers who assume responsibility for their children's care report increased depressive symptoms, family stress, and higher burden. According to Social Cognitive Theory, effective support from parents is crucial for successfully managing childhood chronic illnesses and in facilitating the transition to adult medical care, including GFD management. A review of adherence interventions for youth with CD concluded that there is a significant need for evidence-based interventions to support GFD management, and that potential targets should incorporate considerations of the individual, family, community, and health system. The authors also emphasized the promise of novel technologies as a potentially useful and accessible approach for intervention delivery. The Current Study The current study includes three phases of data collection with human subjects: (1) focus groups, (2) proof-of-concept testing of an intervention, and (3) a randomized controlled trial. In total the investigators will recruit and enroll a sample of 80 parent-teen dyads (ages 12-16 years and a primary caregiver) from our celiac disease clinics in the Division of Gastroenterology Children's National Hospital (CNH) over the course of this 5-year project. Dr. Coburn is an integrated member of the Celiac Disease Program Clinical Team, and has met with colleagues, including the gastroenterologist (Dr. Kerzner, Scientific Advisor), nurse, and dietitian, to discuss the proposed study and all team members have expressed their support for this proposal. Participants will total 70 teens (ages 12 to 16) with celiac disease (CD) and their parents or legal guardians (referred to as "parents" throughout this application) who receive medical care from Children's National Hospital (CNH). In Aim 1, the investigators propose to first refine an intervention modeled after Bread 'N Butter (BNB), an online 6-module intervention for adults with CD. In Aim 2, five parent-teen dyads (n=5 teens and n=5 parents) will complete the intervention to establish proof-of-concept of the intervention and to facilitate additional refinement as needed. In Aim 3, participants will be randomized as dyads into either the intervention group or the control group. Teen participants will be enrolled across the Aims during Years 1 to 4 and follow-up assessments will be completed into Year 5. For Aim 1, n=5 parent-teen dyads will be recruited for focus groups. For Aim 2, n=5 new parent-teen dyads will be recruited for proof-of-concept testing. For Aim 3, n=60 parent-teen dyads will be recruited for the randomized controlled trial (RCT; 30 in the intervention group and 30 in the care-as-usual control group). Participants will be recruited over the course of the study continuously in cohorts for Aims 1, 2, and 3, with active recruitment in the investigators' Celiac Disease Clinic as well as through the existing patient database. Currently, since its inception 3 years ago, the patient database has over 300 patients with CD (89 currently eligible, ages 12-16) and continues to grow by approximately 16 patients per month (4-6 eligible patients on average). After parent-teen dyads have met inclusion criteria, given consent and assent for the RCT, and completed their baseline assessments, the participants will be randomized into either the intervention group or the care-as-usual control group. Assignments will be made using block randomization, stratified by the 4 intervention cohorts of 6-8 dyads each. Considering the significant challenges faced by teens with celiac disease and their families, there is an urgent need to develop tailored, innovative interventions that are appealing to this age group and potentially efficacious in improving celiac disease-related physiologic and psychosocial functioning. The minimal risks of completing data collection and a 6-week behavioral intervention are reasonable to justify the proposed study, which will minimally provide knowledge on behavioral intervention techniques for teens with CD and their parents and could also lead to improved scientific clarity on the mechanisms that underlie management of special diets in youth. In addition, collection of the psychosocial and clinical data may provide information for health professionals to promote optimal clinical care in youth with celiac disease, with the ultimate goal of reducing risk for long term negative health outcomes. The proposed study has the potential to ultimately result in the availability and implementation of an efficacious intervention for a large community of youth with CD and their families throughout the United States and may have utility in other chronic illness populations as well. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05204446
Study type Interventional
Source Children's National Research Institute
Contact
Status Enrolling by invitation
Phase N/A
Start date June 7, 2022
Completion date October 1, 2026

See also
  Status Clinical Trial Phase
Completed NCT04349904 - Near-Focus NBI Classification of Villous Atrophy in Suspected Coeliac Disease: International Development and Validation
Recruiting NCT04593251 - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis Phase 1
Recruiting NCT05555446 - Bovine Colostrum to Prevent Absorption of Gluten Early Phase 1
Completed NCT02754609 - Hookworm Therapy for Coeliac Disease Phase 1
Terminated NCT01902368 - Celiac Disease Screening N/A
Completed NCT02472704 - Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo N/A
Completed NCT02312349 - Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Recruiting NCT01172665 - Celiac Disease Database
Completed NCT01100099 - HLA-DQ2-gliadin Tetramer for Diagnosis of Celiac Disease Phase 2/Phase 3
Completed NCT00639444 - Risk of Celiac Disease and Age at Gluten Introduction N/A
Recruiting NCT05425446 - Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients Phase 1
Enrolling by invitation NCT02202681 - Imaging the Duodenum Using an Optical Frequency Domain Imaging OFDI Capsule N/A
Completed NCT00362856 - Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects Phase 2
Terminated NCT03866538 - Budesonide in Patients With Immune Mediated Enteropathies Phase 4
Recruiting NCT05135923 - Glutenfree, Gut Microbiota and Metabolic Regulation N/A
Completed NCT05052164 - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women N/A
Completed NCT03775499 - Probiotic BL NCC 2705 and Gluten Sensitivity N/A
Recruiting NCT03707730 - A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease Phase 2
Active, not recruiting NCT05548166 - Pediatric Celiac Disease Index: CELIAC-Q KIDS
Completed NCT02244047 - Cytokine Profile in Children With Celiac Disease Phase 1/Phase 2