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. GIP testing is a
promising technology for detecting gluten ingestion, but clinical recommendations and
support for GIP testing are needed. GIP testing has demonstrated reliable and valid
detection of gluten in relation to histological lesions found via duodenal biopsy as well
as high acceptability and feasibility in children and adults. Given the public
availability and potential future affordability of GIP test kits, insight into the
effects of their use on clinically relevant outcomes is crucial. Additionally, enthusiasm
about the potential for accurate biometric assessment of adherence in outcomes research
must also be tempered with the possibility that GIP testing may modify behavior and other
patient-reported outcomes, with potential benefits or iatrogenic effects. Accordingly,
there is an unmet need to counsel patients, particularly teens, on strategies for
proactively using at-home GIP tests and optimize outcomes such as QOL and GFD
self-management.
The Current Study
The current study is a randomized controlled trial. Participants will total 96 teens
(ages 12 to 16 with celiac disease (CD) and their parents or legal guardians (referred to
as "parents") who receive medical care from our celiac disease clinics in the Division of
Gastroenterology Children's National Hospital (CNH). 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.
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 as
dyads into either the "GROW" intervention group, the enhanced "GROW+" intervention group,
or the control group. Assignments will be made using block randomization, stratified by
the 4 intervention cohorts of 8 dyads each. N=96 parent-teen dyads will be recruited
(RCT; 32 in the "GROW" intervention group, 32 in the enhanced "GROW+" intervention group,
and 32 in the care-as-usual control group) over the course of the study continuously in
cohorts with active recruitment in the investigators' Celiac Disease Clinic as well as
through the existing patient database.
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.