Web-based Management of Pediatric Functional Abdominal Pain

March 25, 2019 updated by: Lynn Walker, Vanderbilt University Medical Center

Predicting Treatment Outcomes in Pediatric Functional Abdominal Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 adolescence/early adulthood, PI Walker and colleagues identified three distinct patient profiles (i.e., 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 child's 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 Type

Interventional

Enrollment (Actual)

344

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Referred for medical evaluation of abdominal pain of more than 3 months duration
  • No prior diagnosis of organic disease that explains the pain
  • Access to a computer and the internet

Exclusion Criteria:

  • Presence of major medical condition (e.g., diabetes)
  • Does not speak English
  • Has a disability that precludes participation
  • Does not have a participating parent/guardian
  • Found to have significant organic disease (e.g., ulcerative colitis) in the medical evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online Cognitive Behavior Therapy
Online cognitive behavior therapy for coping with pain
Behavioral: Online Cognitive Behavior Therapy
Active Comparator: Online Education
Educational information about pain
Behavioral: Online Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline somatic symptoms
Time Frame: 2 months after baseline
Change from baseline somatic symptoms as measured by the Children's Somatization Inventory
2 months after baseline
Change from baseline abdominal pain
Time Frame: long-term follow-up (6 and 12 months after baseline)
Change from baseline abdominal pain as measured by Abdominal Pain Index
long-term follow-up (6 and 12 months after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline activity limitations
Time Frame: 2 months after baseline
Change from baseline activity limitations as measured by the Patient Reported Outcomes Measurement Information System Pain Interference Scale
2 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

Seattle Children's Hospital

Investigators

  • Principal Investigator: Lynn Walker, PhD, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

January 16, 2019

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

December 10, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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