Inclusion Criteria:

1. Teens with a physician- confirmed CD diagnosis and one parent or guardian. 2. Teens 12-16 years at baseline. 3. Proficient in written and spoken English. 4. Parent consent and teen assent must be provided. 5. Must also 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.

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 Gluten-Free Diet (GFD), which is complex, expensive, tiring, and anxiety-provoking. CD is also associated with impaired quality of life (QOL) and burdensome treatment. Impaired QOL, including poor psychological well-being and functioning, occurs more frequently in CD compared with the general population, likely due to physiological vulnerabilities associated with CD as well as the social impact of the GFD. Teens with CD may experience psychosocial difficulties associated with the GFD due to negative perceptions about reasons for requesting gluten-free foods. Therefore, despite advances in palatable gluten-free products and their availability, youth with CD continue to struggle with GFD management and face new sources of misinformation and misperceptions by others. Like their children, parents are also at risk for poorer QOL resulting from the challenges associated with the treatment of CD in their children. Parents may experience social isolation and stress associated with caring for a child with CD, which can impact family dynamics and the daily tasks of following the GFD. Caregivers who assume responsibility for their children's care report increased depressive symptoms, family stress, and higher burden. According to Social Cognitive Theory, effective support from parents is crucial for successfully managing childhood chronic illnesses and in facilitating the transition to adult medical care, including GFD management. A review of adherence interventions for youth with CD concluded that there is a significant need for evidence-based interventions to support GFD management, and that potential targets should incorporate considerations of the individual, family, community, and health system. The authors also emphasized the promise of novel technologies as a potentially useful and accessible approach for intervention delivery. The Current Study. The current study includes three phases of data collection with human subjects:

• (1) focus groups, (2) proof-of-concept testing of an intervention, and (3) a randomized controlled trial.

In total the investigators will recruit and enroll a sample of 80 parent-teen dyads (ages 12-16 years and a primary caregiver) from our celiac disease clinics in the Division of Gastroenterology Children's National Hospital (CNH) over the course of this 5-year project. Dr. Coburn is an integrated member of the Celiac Disease Program Clinical Team, and has met with colleagues, including the gastroenterologist (Dr. Kerzner, Scientific Advisor), nurse, and dietitian, to discuss the proposed study and all team members have expressed their support for this proposal. Participants will total 70 teens (ages 12 to 16) with celiac disease (CD) and their parents or legal guardians (referred to as "parents" throughout this application) who receive medical care from Children's National Hospital (CNH). In Aim 1, the investigators propose to first refine an intervention modeled after Bread 'N Butter (BNB), an online 6-module intervention for adults with CD. In Aim 2, five parent-teen dyads (n=5 teens and n=5 parents) will complete the intervention to establish proof-of-concept of the intervention and to facilitate additional refinement as needed. In Aim 3, participants will be randomized as dyads into either the intervention group or the control group. Teen participants will be enrolled across the Aims during Years 1 to 4 and follow-up assessments will be completed into Year 5. For Aim 1, n=5 parent-teen dyads will be recruited for focus groups. For Aim 2, n=5 new parent-teen dyads will be recruited for proof-of-concept testing. For Aim 3, n=60 parent-teen dyads will be recruited for the randomized controlled trial (RCT; 30 in the intervention group and 30 in the care-as-usual control group). Participants will be recruited over the course of the study continuously in cohorts for Aims 1, 2, and 3, with active recruitment in the investigators' Celiac Disease Clinic as well as through the existing patient database. Currently, since its inception 3 years ago, the patient database has over 300 patients with CD (89 currently eligible, ages 12-16) and continues to grow by approximately 16 patients per month (4-6 eligible patients on average). After parent-teen dyads have met inclusion criteria, given consent and assent for the RCT, and completed their baseline assessments, the participants will be randomized into either the intervention group or the care-as-usual control group. Assignments will be made using block randomization, stratified by the 4 intervention cohorts of 6-8 dyads each. Considering the significant challenges faced by teens with celiac disease and their families, there is an urgent need to develop tailored, innovative interventions that are appealing to this age group and potentially efficacious in improving celiac disease-related physiologic and psychosocial functioning. The minimal risks of completing data collection and a 6-week behavioral intervention are reasonable to justify the proposed study, which will minimally provide knowledge on behavioral intervention techniques for teens with CD and their parents and could also lead to improved scientific clarity on the mechanisms that underlie management of special diets in youth. In addition, collection of the psychosocial and clinical data may provide information for health professionals to promote optimal clinical care in youth with celiac disease, with the ultimate goal of reducing risk for long term negative health outcomes. The proposed study has the potential to ultimately result in the availability and implementation of an efficacious intervention for a large community of youth with CD and their families throughout the United States and may have utility in other chronic illness populations as well.

Arms

Experimental: Experimental

Live interactive telehealth-based group meetings will be held for 30 minutes per week over six weeks using Zoom for Telehealth, a HIPAA-compliant platform provided by the PI's institution. A teen group (n=6-8 per cohort) and a parent group (n=6-8 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.

No Intervention: Control Group

(Care-As-Usual): Participants assigned to the control group (n=30 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.

Interventions

Behavioral: - Food for Thought

A total of up to four sequential cohorts (n=30 teen-parent dyads total) will complete the intervention. Participants assigned to the intervention group will be placed into groups of 6-8 teens and 6-8 parents to participate in parallel group sessions.