Managing Recurrent Abdominal Pain
Recruitment status was Recruiting
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).
Behavioral: social learning and cognitive behavioral therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Intergenerational Transmission of Illness Behavior|
- 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 ]
- 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 ]
|Study Start Date:||November 2003|
|Estimated Study Completion Date:||October 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494260
|Contact: Rona Levy, PhDfirstname.lastname@example.org|
|United States, New Jersey|
|Goryeb Children's Hospital/ Atlantic Health System||Recruiting|
|Morristown, New Jersey, United States, 07962|
|Contact: Nader Youssef, MD 973-971-5676 Nader.Youssef@ahsys.org|
|Principal Investigator: Nader Youssef, PhD|
|United States, Washington|
|University of Washington/ Children's Hospital and Regional Medical Center||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Rona Levy, PhD 206-543-5917 email@example.com|
|Principal Investigator: Rona Levy, PhD|
|Sub-Investigator: Joan Romano, PhD|
|Sub-Investigator: Shelby Langer, PhD|
|Sub-Investigator: Andrew Feld, MD|
|Sub-Investigator: Dennis Christie, MD|
|Principal Investigator:||Rona Levy, PhD||School of Social Work, University of Washington|