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Behavioral Intervention for Celiac Disease

Key facts

Where
Washington D.C., United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 12 and 16 years old?

Source: NCT05204446, who can take part

Where in United States

  • Children's National HospitalWashington D.C., United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Children's National Research Institute
Trial code
NCT05204446
Record updated
11 July 2025
Original description
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.Read full original descriptionShow less

Testing a Behavioral Intervention in Pediatric Celiac Disease

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.

Inclusion: 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.

Exclusion: 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; 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.

ClinicalTrials.gov NCT05204446