Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05204446
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-19
First Post:
2021-06-14
Brief Title:
Behavioral Intervention for Celiac Disease
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Testing a Behavioral Intervention in Pediatric Celiac Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 n96 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
Detailed 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-Hodgkins 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 childrens 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 Childrens 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 N96 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
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 Childrens 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 N96 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None