Behavioral Intervention for Celiac Disease

Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Children's National Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for teens aged 12-16 with a confirmed diagnosis of Celiac Disease, along with one parent or guardian. They must be able to use video conferencing and SMS messaging, speak English fluently, and receive care from the Children's National Hospital's celiac clinic. Teens with developmental disabilities or major neuropsychological conditions that could affect participation are not eligible.

Inclusion Criteria

I am between 12 and 16 years old.

I am a teenager diagnosed with Crohn's disease and have a parent or guardian.

Treatment Details

The GROW Project aims to help teens with Celiac Disease and their parents manage a gluten-free diet by improving knowledge, behavior, and coping skills through educational and cognitive-behavioral techniques delivered via telehealth and text messages. The study will test this intervention in a small pilot randomized control trial to see if it improves quality of life and diet management.

3Treatment groups

Experimental Treatment

Active Control

Group I: GROW+ ProjectExperimental Treatment1 Intervention

("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.

Group II: GROW ProjectExperimental Treatment1 Intervention

("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.

Group III: Care-As-UsualActive Control1 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.