Managing Recurrent Abdominal Pain

Abdominal Pain Clinical Trial

Official title:

Intergenerational Transmission of Illness Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494260
• Other study ID #: R01HD036069-07
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2007
• Last updated: March 30, 2016
• Start date: November 2003
• Est. completion date: June 2010

Study information

• Verified date: March 2016
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Illness Behavior

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Goryeb Children's Hospital/ Atlantic Health System	Morristown	New Jersey
United States	University of Washington/ Children's Hospital and Regional Medical Center	Seattle	Washington

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms of recurrent abdominal pain		measured one week following treatment and again in 3, 6 and 12 months	No
Primary	disability		measured one week following treatment and again in 3, 6 and 12 months	No
Secondary	parent behaviors		measured one week following treatment and again in 3, 6 and 12 months	No
Secondary	child coping behaviors		measured one week following treatment and again in 3, 6 and 12 months	No