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Managing Recurrent Abdominal Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00494260
First Posted: June 29, 2007
Last Update Posted: March 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
June 28, 2007
June 29, 2007
March 31, 2016
November 2003
June 2010   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00494260 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Managing Recurrent Abdominal Pain
Intergenerational Transmission of Illness Behavior
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).

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Abdominal Pain
  • 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
  • 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.
  • 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.
    Intervention: Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT)
  • 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.
    Intervention: Behavioral: Education Support (ES)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
7 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00494260
R01HD036069-07( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Rona Levy, PhD School of Social Work, University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP