Managing Recurrent Abdominal Pain
Intergenerational Transmission of Illness Behavior
1 other identifier
interventional
200
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2003
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 28, 2007
CompletedFirst Posted
Study publicly available on registry
June 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedMarch 31, 2016
March 1, 2016
6.6 years
June 28, 2007
March 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (2)
Social learning and cognitive behavioral therapy (SLCBT)
EXPERIMENTALThe 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)
ACTIVE COMPARATORThe 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.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Goryeb Children's Hospital/ Atlantic Health System
Morristown, New Jersey, 07962, United States
University of Washington/ Children's Hospital and Regional Medical Center
Seattle, Washington, 98105, United States
Related Publications (3)
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.
PMID: 15571594BACKGROUNDLevy 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.
PMID: 10685749BACKGROUNDLevy 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.
PMID: 23277304DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rona Levy, PhD
School of Social Work, University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2007
First Posted
June 29, 2007
Study Start
November 1, 2003
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
March 31, 2016
Record last verified: 2016-03