Managing Recurrent Abdominal Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00494260
First received: June 28, 2007
Last updated: July 2, 2007
Last verified: July 2007
  Purpose

The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).


Condition Intervention Phase
Abdominal Pain
Behavioral: social learning and cognitive behavioral therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Intergenerational Transmission of Illness Behavior

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • symptoms of recurrent abdominal pain [ Time Frame: measured one week following treatment and again in 3, 6 and 12 months ]
  • disability [ Time Frame: measured one week following treatment and again in 3, 6 and 12 months ]

Secondary Outcome Measures:
  • parent behaviors [ Time Frame: measured one week following treatment and again in 3, 6 and 12 months ]
  • child coping behaviors [ Time Frame: measured one week following treatment and again in 3, 6 and 12 months ]

Estimated Enrollment: 200
Study Start Date: November 2003
Estimated Study Completion Date: October 2008
Detailed Description:

Recurrent Abdominal Pain (RAP) is one of many disorders in adults and children for which there is no identifiable organic or physiological cause, yet which is associated with illness behavior that has significant societal and personal costs. Although 10-15% of children have RAP, there is at present no accepted medical or behavioral treatment for it. We have conducted a series of studies that suggests that illness behavior is, at least in part, learned during childhood when parents model sick role behavior or respond to their children's somatic complaints in a way that encourages or reinforces sick role behavior. The goal of this project is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with RAP.

The study is a randomized clinical trial. Children with RAP are assigned to one of two treatment conditions: 1) a social learning and cognitive behavior therapy condition (SLCBT) or 2) an education and support condition (ES). The SLCBT protocol teaches parents and children cognitive-behavioral methods such as relaxation and coping for managing RAP pain and stress. Patients and parents in the ES condition receive educational information regarding nutrition and the gastrointestinal system. Both treatment arms consist of three sessions with a mental health professional, each one week apart.

Study families are recruited from physicians in the community and through community flyers and newsletters. Outcome measures are collected at baseline, end of treatment, and at follow-up evaluations conducted three, six and 12 months later. Measures are designed to assess: RAP symptoms, health care utilization, psychological symptoms, school absences, functional disabilities, and family stress).

Primary Hypothesis: Children in the SLCBT condition will exhibit a greater decrease in symptoms of RAP and related maladaptive behaviors and cognitions than children in a comparison condition.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • child experienced at least 3 episodes of abdominal pain over a 3-month period which affected his/her activities
  • primary caregiver willing and able to complete questionnaires
  • child aged 7-17
  • child has lived with the primary caregiver full-time for at least the past 5 years and for at least half of his/her lifetime

Exclusion Criteria:

  • positive physical or laboratory findings which would explain the child's abdominal pain
  • chronic disease
  • major surgery in past year
  • developmental disabilities that require full-time special education or impair ability to respond
  • inability to comprehend English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494260

Contacts
Contact: Rona Levy, PhD 206.543.5917 rlevy@u.washington.edu

Locations
United States, New Jersey
Goryeb Children's Hospital/ Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07962
Contact: Nader Youssef, MD    973-971-5676    Nader.Youssef@ahsys.org   
Principal Investigator: Nader Youssef, PhD         
United States, Washington
University of Washington/ Children's Hospital and Regional Medical Center Recruiting
Seattle, Washington, United States, 98105
Contact: Rona Levy, PhD    206-543-5917    rlevy@u.washington.edu   
Principal Investigator: Rona Levy, PhD         
Sub-Investigator: Joan Romano, PhD         
Sub-Investigator: Shelby Langer, PhD         
Sub-Investigator: Andrew Feld, MD         
Sub-Investigator: Dennis Christie, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Rona Levy, PhD School of Social Work, University of Washington
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00494260     History of Changes
Other Study ID Numbers: R01 HD 36069-07
Study First Received: June 28, 2007
Last Updated: July 2, 2007
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
recurrent abdominal pain
illness behavior
social learning
cognitive behavioral therapy

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on April 17, 2014