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Web-based Management of Pediatric Functional Abdominal Pain

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ClinicalTrials.gov Identifier: NCT02327377
Recruitment Status : Active, not recruiting
First Posted : December 30, 2014
Last Update Posted : March 20, 2018
Seattle Children's Hospital
Information provided by (Responsible Party):
Lynn Walker, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment
Gastrointestinal Disorders, Functional Behavioral: Online Cognitive Behavior Therapy Behavioral: Online Education

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  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Predicting Treatment Outcomes in Pediatric Functional Abdominal Pain
Study Start Date : April 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Change from baseline somatic symptoms [ Time Frame: 2 months after baseline ]
    Change from baseline somatic symptoms as measured by the Children's Somatization Inventory

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327377

United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Seattle Children's Hospital
Principal Investigator: Lynn Walker, PhD Vanderbilt University

Responsible Party: Lynn Walker, Professor of Pediatrics; Division Director, Adolescent & Young Adult Health, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02327377     History of Changes
Other Study ID Numbers: 140559
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lynn Walker, Vanderbilt University Medical Center:
Irritable bowel syndrome
Intervention studies
Visceral pain
Chronic pain
Abdominal pain
Coping behavior
Reinforcement (psychology)
Self efficacy
Health services overutilization
Self report
Health surveys
Prospective studies
Adolescent health
Mental health services
Health services accessibility
Health diaries
National Institute of Child Health & Human Development (US.)
Web-based intervention
Parenting education

Additional relevant MeSH terms:
Abdominal Pain
Digestive System Diseases
Gastrointestinal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive