Managing Childhood Abdominal Pain (MCAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Washington
Sponsor:
Collaborators:
University of North Carolina
Mary Bridge Children's Hospital
Information provided by (Responsible Party):
Rona Levy, University of Washington
ClinicalTrials.gov Identifier:
NCT01620606
First received: February 14, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

Functional abdominal pain (FAP) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. The study will test a treatment approach which, if successful, would substantially change the treatment for FAP and potentially for a wide range of childhood medical problems where parental responses to symptoms contribute to these adverse effects. The study would also provide a model which would be much more accessible than traditional face-to-face therapies to a broader range of families in need than are currently served.


Condition Intervention
Pediatric Abdominal Pain
Behavioral: Cognitive Behavioral Therapy & Social Learning
Behavioral: Education and Support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Parent Training to Address Pediatric Functional Abdominal Pain

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Abdominal Pain Index [ Time Frame: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adults' Responses to Children's Symptoms [ Time Frame: Baseline, 1-3 days post treatment session 1, 1-3 days post treatment session 2,1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3 ] [ Designated as safety issue: No ]
  • Pain Response Inventory [ Time Frame: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3 ] [ Designated as safety issue: No ]
  • Pain Beliefs Questionnaire [ Time Frame: Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3 ] [ Designated as safety issue: No ]
  • Pain Catastrophizing Scale [ Time Frame: Baseline, 1-3 days post treatment session 1, 1-3 days post treatment session 2,1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SLCBT
Social Learning and Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy & Social Learning
Cognitive Behavioral Therapy & Social Learning
Experimental: SLCBT-R
Phone-based Social Learning and Cognitive Behavioral Therapy
Behavioral: Cognitive Behavioral Therapy & Social Learning
Cognitive Behavioral Therapy & Social Learning
Active Comparator: ES
Education and Support
Behavioral: Education and Support
Education about the GI system, nutrition and food safety

Detailed Description:

Functional Abdominal Pain (FAP) affects 10 to 15% of children and has significant social, emotional, and financial costs, but no known organic cause and no accepted medical or behavioral treatment. The researchers have conducted studies that provide support for a theoretical model in which cognitive-behavioral and social learning processes (modeling and/or potentially reinforcing responses by parents) may contribute to the maintenance of illness behaviors and functional disability in children with FAP. The researchers subsequently tested a social learning and cognitive-behavioral intervention for parent-child dyads which focused on changing these parent behaviors as well as teaching coping skills to children. Results support the effectiveness of the intervention and the explanatory value of the theory, demonstrating that parental change is a key element in reducing children's symptoms. The proposed study will build on these findings by evaluating a parent-only intervention. Furthermore, our experience and that of other investigators indicates that alternative intervention models are needed for wider accessibility to the intervention for families in need. While a parent-only format is expected to increase accessibility, we will also evaluate the use of a remote telephone intervention.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The child is 7 to 12 years old
  • The child experienced at least three episodes of unexplained abdominal pain over a three month period which affected the child's activities
  • The child lived with the primary caregiver for at least the last 3 months
  • The child and the parent agree to the conditions of study participation, including randomization, participation in intervention and follow-up evaluations
  • The parent and child comprehend and speak English without assistance

Exclusion Criteria:

  • The child has positive physical or laboratory findings which would explain the abdominal pain
  • The child has a chronic disease (e.g. Crohn's, ulcerative colitis, pancreatitis, diabetes, epilepsy, etc.)
  • The child is lactose intolerant
  • The child had major surgery in the past year
  • The parent or child has developmental disabilities that require full-time special education or that impair ability to respond to assessment measures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620606

Contacts
Contact: Sheri Ballard, BA 206-616-2358 mcap@uw.edu

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States
Contact: Miranda vanTilburg, PhD    919-843-0688      
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Heather Vendettuoli    206-987-0055    heather.vendettuoli@seattlechildrens.org   
Principal Investigator: Dennis Christie, MD         
Mary Bridge Children's Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Mohammed El-Majzoub    253-403-3131    mo.elmajzoub@gmail.com   
Sponsors and Collaborators
University of Washington
University of North Carolina
Mary Bridge Children's Hospital
Investigators
Principal Investigator: Rona L Levy, MSW, MPH, PhD University of Washington
Principal Investigator: Miranda vanTilburg, PhD University of North Carolina
  More Information

No publications provided

Responsible Party: Rona Levy, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01620606     History of Changes
Other Study ID Numbers: CHRMC13744
Study First Received: February 14, 2012
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
FAP
RAP
Abdominal Pain
IBS

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014