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).

Study Overview

• Status: Completed
• Conditions: Abdominal Pain
• Intervention / Treatment: Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT); Behavioral: Education Support (ES)

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
symptoms of recurrent abdominal pain	measured one week following treatment and again in 3, 6 and 12 months
disability	measured one week following treatment and again in 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
parent behaviors	measured one week following treatment and again in 3, 6 and 12 months
child coping behaviors	measured one week following treatment and again in 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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. doi: 10.1111/j.1572-0241.2004.40478.x.
• Levy RL, Whitehead WE, Von Korff MR, Feld AD. Intergenerational transmission of gastrointestinal illness behavior. Am J Gastroenterol. 2000 Feb;95(2):451-6. doi: 10.1111/j.1572-0241.2000.01766.x.
• Levy RL, Langer SL, Walker LS, Romano JM, Christie DL, Youssef N, DuPen MM, Ballard SA, Labus J, Welsh E, Feld LD, Whitehead WE. Twelve-month follow-up of cognitive behavioral therapy for children with functional abdominal pain. JAMA Pediatr. 2013 Feb;167(2):178-84. doi: 10.1001/2013.jamapediatrics.282.

Helpful Links

• study overview for patients, families and providers

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 28, 2007
• First Submitted That Met QC Criteria: June 28, 2007
• First Posted (Estimate): June 29, 2007

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; recurrent abdominal pain; social learning; illness behavior
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Illness Behavior
• Other Study ID Numbers: R01HD036069-07 (U.S. NIH Grant/Contract)