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NCT05204446

Behavioral Intervention for Celiac Disease

Enrolling by Invitation
NAAges 12–16InterventionalSupportive care
Children's National Research Institute
~96 participants
Updated 2025-07-11 on ClinicalTrials.gov
What's tested:GROW ProjectGROW+ Project

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Teen quality of life as measured by Teen and parent-proxy report on PROMIS Pediatric Profile-37
Measured over Baseline, Immediately Post-Intervention, 3 Month Follow-Up
+7 more outcomes measured

Conditions

Celiac Disease

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Celiac Disease

NCT05204446

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's National Hospital

    Washington D.C., District of Columbiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • Teen quality of life as measured by Teen and parent-proxy report on PROMIS Pediatric Profile-37Baseline, Immediately Post-Intervention, 3 Month Follow-Up

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

  • Parent quality of life as measured by Parent PROMIS Adult Profile-43Baseline, Immediately Post-Intervention, 3 Month Follow-Up

    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

  • Parent health-related quality of life as measured by Parent report PedsQL 2.0 Family Impact ModuleBaseline, Immediately Post-Intervention, 3 Month Follow-Up

    Parent impact of child health on quality of life

  • Teen celiac disease health-related quality of life as measured by Teen self-report on Celiac Disease Quality of Life (CDLIFE)Baseline, Immediately Post-Intervention, 3 Month Follow-Up

    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.

  • Gluten-Free Diet Management (expert) as measured by Expert GFD Adherence Rating (SDE)Baseline, Immediately Post-Intervention, 3 Month Follow-Up

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

  • Gluten-free diet management as measured by Teen & Parent-report Celiac Dietary Adherence TestBaseline, Immediately Post-Intervention, 3 Month Follow-Up

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

  • Gluten Immunogenic Peptides as measured by GlutenDetectBaseline, Weekly Intervention, Immediately Post-Intervention, 3 Month Follow-Up

    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.

  • Gluten-Free Diet Experiences as assessed by qualitative interview about perceived QOL and GFD management experiencesBaseline, Immediately Post-Intervention, 3 Month Follow-Up

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