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Managing Childhood Abdominal Pain (MCAP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Rona Levy, University of Washington.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01620606
First Posted: June 15, 2012
Last Update Posted: October 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of North Carolina
MultiCare Mary Bridge Children's Hospital & Health Center
Information provided by (Responsible Party):
Rona Levy, University of Washington
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Parent Training to Address Pediatric Functional Abdominal Pain

Resource links provided by NLM:


Further study details as provided by Rona Levy, 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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620606


Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Mary Bridge Children's Hospital
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
University of Washington
University of North Carolina
MultiCare Mary Bridge Children's Hospital & Health Center
Investigators
Principal Investigator: Rona L Levy, MSW, MPH, PhD University of Washington
Principal Investigator: Miranda vanTilburg, PhD University of North Carolina
  More Information

Responsible Party: Rona Levy, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01620606     History of Changes
Other Study ID Numbers: CHRMC13744
First Submitted: February 14, 2012
First Posted: June 15, 2012
Last Update Posted: October 7, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive