Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05204446 |
| Other study ID # |
Pro00015490 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 7, 2022 |
| Est. completion date |
October 1, 2026 |
Study information
| Verified date |
October 2023 |
| Source |
Children's National Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
