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Behavioral Intervention for Celiac Disease

N/A

Waitlist Available

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Teens 12-16 years at the time of enrollment

Teens with a physician-confirmed CD diagnosis and one parent or guardian

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediately post-intervention, 3 month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to help people with celiac disease who have to follow a strict gluten-free diet. The trial is testing a new intervention delivered through text messages and telehealth to help teens with celiac disease and their parents. The goal is to improve quality of life and management of the gluten-free diet by targeting self-efficacy, illness identity, and food-related activities.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a behavioral intervention focusing on education and coping strategies rather than medication or medical procedures, there are no direct physical side effects expected from participating in the GROW Project.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 16 years old.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediately post-intervention, 3 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediately post-intervention, 3 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately post-intervention, 3 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gluten Immunogenic Peptides as measured by GlutenDetect

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

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

+5 more

Secondary study objectives

Illness Identity as measured by the Illness Identity Questionnaire

Self-Efficacy as measured by the Celiac-SE

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met