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

June 28, 2007
March 30, 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 ] [ 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 ]
  • 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 ]
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 ] [ 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 ]
  • 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 ]
Not Provided
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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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
Both
7 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00494260
R01HD036069-07
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