Clinical trial NCT00494260: Managing Recurrent Abdominal Pain
Official title: Intergenerational Transmission of Illness Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abdominal Pain
Keywords: recurrent abdominal pain
illness behavior
social learning
cognitive behavioral therapy
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2007-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: symptoms of recurrent abdominal pain
timeFrame: measured one week following treatment and again in 3, 6 and 12 months
measure: disability
timeFrame: measured one week following treatment and again in 3, 6 and 12 months
Secondary outcomes:
measure: parent behaviors
timeFrame: measured one week following treatment and again in 3, 6 and 12 months
measure: child coping behaviors
timeFrame: measured one week following treatment and again in 3, 6 and 12 months
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Goryeb Children's Hospital/ Atlantic Health System
state: New Jersey
city: Seattle
country: United States
facility: University of Washington/ Children's Hospital and Regional Medical Center
state: Washington
Study officials:
affiliation: School of Social Work, University of Washington
name: Rona Levy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1572-0241.2004.40478.x.
citation: 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.
citation: 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.