Managing Recurrent Abdominal Pain

United States Department of Health and Human Services (HHS)

Status and phase: Completed; Phase 2

Conditions: Abdominal Pain

Treatments: Behavioral: Education Support (ES); Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT)

Study type: Interventional

Funder types: NIH

Identifiers

NCT00494260

R01HD036069-07

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Social learning and cognitive behavioral therapy (SLCBT)

Experimental group

Description:

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.

Treatment:

Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT)

Education Support (ES)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Education Support (ES)