Ignite Creation Date:
2024-05-06 @ 3:34 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02327377
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2014-12-10
Brief Title:
Web-based Management of Pediatric Functional Abdominal Pain
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Predicting Treatment Outcomes in Pediatric Functional Abdominal Pain
Status:
COMPLETED
Status Verified Date:
2019-03
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:
Functional abdominal pain FAP a pediatric pain condition without significant organic pathology is a precursor to chronic pain and high healthcare utilization in young adulthood This project aims to identify child and family characteristics that predict differential responses to a Cognitive Behavior Therapy intervention administered online to patients with FAP and their parents The goal is to acquire scientific knowledge to guide individualized treatment of patients with FAP
Detailed Description:
The goal of our research is to identify individual differences in pediatric functional abdominal pain FAP that predict differential health outcomes and can be used to develop tailored approaches to the evaluation and treatment of FAP Effective treatment of FAP is a critical public health issue because it is among the most common pain problems during childhood and prospectively predicts risk for chronic pain disability and frequent health service utilization HSU in early adulthood Although cognitive behavior therapy CBT delivered by highly trained professionals in face-to-face sessions has been found to reduce pain in some FAP patients such intensive resources are not generally available to the large population of FAP patients This study will evaluate an alternative more efficient approach to treating pediatric FAP The study builds on and integrates recent work by two leading investigators in pediatric pain First in a prospective natural history study of pediatric onset FAP patients followed into late adolescenceearly adulthood PI Walker and colleagues identified three distinct patient profiles ie Low Pain Adaptive High Pain Adaptive High Pain Dysfunctional comprised of pain severity pain cognitions and affect at the time of the initial FAP evaluation in childhood These profiles predicted chronic pain and related health outcomes at follow-up FU nearly a decade later Patients with the High Pain Dysfunctional profile at baseline had the poorest symptom outcomes and also exhibited pro-nociceptive central pain modulation in laboratory pain testing at FU The heterogeneity of the FAP pain profile groups suggests that they may differ in treatment needs and in the extent to which they benefit significantly more from adjunctive behavioral treatment as compared to usual care alone Second Co-Investigator Palermo developed and tested a CBT intervention delivered online Web-based Management of Adolescent Pain Web-MAP which is an efficient easily disseminated treatment that significantly reduced pain and disability in youth with a variety of chronic pain diagnoses in comparison to youth randomized to a usual care wait-list control group This study merges these lines of research into an innovative study that will for the first time Aim 1 evaluate the efficacy of WebMAP administered to FAP patients and their parents Aim 2 evaluate baseline moderators of treatment response including our previously validated FAP pain profiles pro-nociceptive central pain modulation and parent characteristics protectiveness modeling pain behavior catastrophizing about the childs pain and Aim 3 evaluate potential mediators of the effect of WebMAP on health outcomes Pediatric patients n 300 ages 11-17 years will be randomized to either WebMAP or a Usual Care UC control group following their initial subspecialty FAP evaluation Assessments will be at baseline mid- and post-treatment and at 6- and 12-months post baseline Study results will produce knowledge that can be used to more efficiently target interventions to FAP patients according to their individual needs and thereby extend evidence-based care to more patients and ultimately reduce overall costs of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None