Behavioral Intervention for Celiac Disease

NCT05204446 | Enrolling By Invitation

• 1 other identifier: Pro00015490
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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=96 dyads) that 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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (8)

• Teen quality of life as measured by Teen and parent-proxy report on PROMIS Pediatric Profile-37

  Anxiety, depressive symptoms, fatigue, pain interference, physical function-mobility, peer relationships, \& pain intensity

  Baseline, Immediately Post-Intervention, 3 Month Follow-Up

• Parent quality of life as measured by Parent PROMIS Adult Profile-43

  Parent anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item

  Baseline, Immediately Post-Intervention, 3 Month Follow-Up

• Parent health-related quality of life as measured by Parent report PedsQL 2.0 Family Impact Module

  Parent impact of child health on quality of life

  Baseline, Immediately Post-Intervention, 3 Month Follow-Up

• Teen celiac disease health-related quality of life as measured by Teen self-report on Celiac Disease Quality of Life (CDLIFE)

  A validated measure of health-related quality of life in children ages 8-18 living with celiac disease in the United States. 22 items rated 1 (never) to 5 (almost always) for a total possible score ranging from 0-88, with a higher score indicating better health-related quality of life.

  Baseline, Immediately Post-Intervention, 3 Month Follow-Up

• Gluten-Free Diet Management (expert) as measured by Expert GFD Adherence Rating (SDE)

  Structured global rating by gluten-free diet expert based on dietary recall for potential sources of gluten using online GlutenFreeDiet program.

  Baseline, Immediately Post-Intervention, 3 Month Follow-Up

• Gluten-free diet management as measured by Teen & Parent-report Celiac Dietary Adherence Test

  Survey measure on symptoms and behavior associated with gluten-free diet management

  Baseline, Immediately Post-Intervention, 3 Month Follow-Up

• Gluten Immunogenic Peptides as measured by GlutenDetect

  At-home Gluten Detective kit to detect gluten ingested within 24 hours in teen's urine or stool. Teens will be prompted via SMS text message and will be given a 24-hour window to complete the test and send a photo of the results.

  Baseline, Weekly Intervention, Immediately Post-Intervention, 3 Month Follow-Up

• Gluten-Free Diet Experiences as assessed by qualitative interview about perceived QOL and GFD management experiences

  Semi-structured qualitative interview about current experiences with GFD management for teen/parent.

  Baseline, Immediately Post-Intervention, 3 Month Follow-Up

Secondary Outcomes (2)

• Self-Efficacy as measured by the Celiac-SE

  Baseline, Immediately Post-Intervention, 3 Month Follow-Up

• Illness Identity as measured by the Illness Identity Questionnaire

  Baseline, Immediately Post-Intervention, 3 Month Follow-Up

Study Arms (3)

GROW Project

EXPERIMENTAL

("GROW" Group): Live interactive telehealth-based group meetings will be held for 60 minutes per week over six weeks using Zoom for Telehealth, a HIPAA-compliant platform provided by the PI's institution. A teen group (n=8 per cohort) and a parent group (n=8 per cohort) will be run concurrently but separately, with coordinating topics. Each group meeting will introduce and facilitate discussion of information and CBT-oriented topics for coping and management of CD. Participants will be encouraged to use their audio and video to engage with the interventionist and each other. Between sessions, resources sent through text-based SMS messages using Twilio HIPAA-compliant software 3x/week as reminders of skills and goals for the week.

Behavioral: GROW Project

Care-As-Usual

NO INTERVENTION

Participants assigned to the control group (n=32 dyads) will receive care as usual, which consists of appointments in the Celiac Disease Clinic (at diagnosis, 3 months post-diagnosis, 6 months post-diagnosis, and annually after diagnosis thereafter). These appointments consist of a gastrointestinal physician or nurse practitioner, dietitian, GFD educator, and psychologist for 40-minute consultations each.

GROW+ Project

EXPERIMENTAL

("GROW+" Group): Will include the GROW Project with enhanced behavioral strategies and materials identified from phase 2 data (e.g., group discussion about GIP testing, text-based check-ins, etc.) In addition, teens in GROW+ will be encouraged to complete a minimum of 2 GlutenDetect tests per week (12 total) and report results in REDCap (Research Electronic Data Capture, a secure, web-based survey application) throughout the intervention.

Behavioral: GROW+ Project

Interventions

GROW+ Project BEHAVIORAL

("GROW+" Group): Will include the GROW Project with enhanced behavioral strategies and materials identified from phase 2 data (e.g., group discussion about GIP testing, text-based check-ins, etc.) In addition, teens in GROW+ will be encouraged to complete a minimum of 2 GlutenDetect tests per week (12 total) and report results in REDCap (Research Electronic Data Capture, a secure, web-based survey application) throughout the intervention.

GROW+ Project

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Teens with a physician- confirmed CD diagnosis and one parent or guardian.
• Teens 12-16 years at the time of enrollment.
• Proficient in written and spoken English.
• Have regular access to a device enabled for video conferencing (Zoom) and receiving SMS messages.

You may not qualify if:

• The teen's CD diagnosis is questioned or revoked at any time during the study period;
• Another member of their household is already enrolled in the study;
• The teen has a developmental disability or major neuropsychological condition that, in the opinion of the investigators, would impair communication and engagement with the other participants and intervention material.

Sponsors & Collaborators

• Children's National Research Institute: lead
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Shayna Coburn, PhD. Assistant Professor and Attending Psychologist Division of Gastroenterology, Children's National Hospital, George Washington School of Medicine and Health Sciences

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: January 24, 2022
• Study Start: June 7, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)