Children's National Research Institute
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.
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 Glut…
Inclusion Criteria: 1. Teens with a physician- confirmed CD diagnosis and one parent or guardian. 2. Teens 12-16 years at the time of enrollment. 3. Proficient in written and spoken English. 4. Have regular access to a device enabled for video conferencing (Zoom) and receiving SMS messages. Exclusion Criteria: 1. The teen's CD diagnosis is questioned or revoked at any time during the study period; 2. Another member of their household is already enrolled in the study; 3. The teen has a developmental disability or major neuropsychological condition that, in the opinion of the investigators, w…
("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.
("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.
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