Web-based Management of Pediatric Functional Abdominal Pain

NCT02327377 | Completed

• 1 other identifier: 140559
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Disorders, Functional

Keywords

Irritable bowel syndrome; Intervention studies; Visceral pain; Chronic pain; Abdominal pain; Dyspepsia; Nausea; Nociception; Parents; Coping behavior; Anxiety; Depression; Catastrophization; Reinforcement (psychology); Self efficacy; Health services overutilization; Questionnaires; Self report; Health surveys; Prospective studies; Adolescent health; Mental health services; Health services accessibility; Health diaries; National Institute of Child Health & Human Development (US.); Telemedicine; E-Health; Web-based intervention; Parenting education

Outcome Measures

Primary Outcomes (2)

• Change from baseline somatic symptoms

  Change from baseline somatic symptoms as measured by the Children's Somatization Inventory

  2 months after baseline

• Change from baseline abdominal pain

  Change from baseline abdominal pain as measured by Abdominal Pain Index

  long-term follow-up (6 and 12 months after baseline)

Secondary Outcomes (1)

• Change from baseline activity limitations

  2 months after baseline

Study Arms (2)

Online Cognitive Behavior Therapy

EXPERIMENTAL

Online cognitive behavior therapy for coping with pain

Behavioral: Online Cognitive Behavior Therapy

Online Education

ACTIVE COMPARATOR

Educational information about pain

Behavioral: Online Education

Interventions

Online Cognitive Behavior Therapy BEHAVIORAL

Online Cognitive Behavior Therapy

Online Education BEHAVIORAL

Online Education

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Seattle Children's Hospital: collaborator

Study Sites (1)

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Walker LS, Stone AL, Han GT, Garber J, Bruehl S, Smith CA, Anderson J, Palermo TM. Internet-delivered cognitive behavioral therapy for youth with functional abdominal pain: a randomized clinical trial testing differential efficacy by patient subgroup. Pain. 2021 Dec 1;162(12):2945-2955. doi: 10.1097/j.pain.0000000000002288.

  PMID: 34793406 DERIVED

MeSH Terms

Conditions

Gastrointestinal Diseases; Irritable Bowel Syndrome; Visceral Pain; Chronic Pain; Abdominal Pain; Dyspepsia; Nausea; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lynn Walker, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics; Division Director, Adolescent & Young Adult Health

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 30, 2014
• Study Start: April 1, 2014
• Primary Completion: January 16, 2019
• Study Completion: January 28, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

US (1)