Managing Recurrent Abdominal Pain - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00494260

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 II

MedlinePlus related topics: Abdominal Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Intergenerational Transmission of Illness Behavior

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Rona Levy, PhD

School of Social Work, University of Washington

More Information

study overview for patients, families and providers This link exits the ClinicalTrials.gov site

Publications:

Levy RL, Whitehead WE, Walker LS, Von Korff M, Feld AD, Garner M, Christie D. Increased somatic complaints and health-care utilization in children: effects of parent IBS status and parent response to gastrointestinal symptoms. Am J Gastroenterol. 2004 Dec;99(12):2442-51.

Levy RL, Whitehead WE, Von Korff MR, Feld AD. Intergenerational transmission of gastrointestinal illness behavior. Am J Gastroenterol. 2000 Feb;95(2):451-6.

Study ID Numbers:	R01 HD 36069-07
Study First Received:	June 28, 2007
Last Updated:	July 2, 2007
ClinicalTrials.gov Identifier:	NCT00494260
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

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Abdominal Pain
Pain
Recurrence

ClinicalTrials.gov processed this record on January 16, 2009