Managing Recurrent Abdominal Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00494260
First received: June 28, 2007
Last updated: March 30, 2016
Last verified: March 2016
  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 (SLCBT)
Behavioral: Education Support (ES)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
  • disability [ Time Frame: measured one week following treatment and again in 3, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • parent behaviors [ Time Frame: measured one week following treatment and again in 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • child coping behaviors [ Time Frame: measured one week following treatment and again in 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: November 2003
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social learning and cognitive behavioral therapy (SLCBT)
The SLCBT condition consists of 3 main components: 1.) relaxation training, 2.) working with parent and child to modify family responses to illness and wellness behaviors, and 3.) cognitive restructuring to address and alter dysfunctional cognitions regarding symptoms and their implications for functioning through cognitive therapy techniques.
Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT)
The SLCBT condition consists of 3 main components: 1.) relaxation training, 2.) working with parent and child to modify family responses to illness and wellness behaviors, and 3.) cognitive restructuring to address and alter dysfunctional cognitions regarding symptoms and their implications for functioning through cognitive therapy techniques
Active Comparator: Education Support (ES)
The ES condition focuses on education about GI system anatomy and function, information about the United States Department of Agriculture nutrition guidelines, and additional food-related information such as how to read food product labels. The ES condition was developed to provide a credible alternative condition that would control for therapist and patient time and attention.
Behavioral: Education Support (ES)
The ES condition focuses on education about GI system anatomy and function, information about the United States Department of Agriculture nutrition guidelines, and additional food-related information such as how to read food product labels. The ES condition was developed to provide a credible alternative condition that would control for therapist and patient time and attention.

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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00494260

Locations
United States, New Jersey
Goryeb Children's Hospital/ Atlantic Health System
Morristown, New Jersey, United States, 07962
United States, Washington
University of Washington/ Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00494260     History of Changes
Other Study ID Numbers: R01HD036069-07 
Study First Received: June 28, 2007
Last Updated: March 30, 2016
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
Illness Behavior
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on August 22, 2016