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Managing Childhood Abdominal Pain (MCAP)

Primary Purpose

Pediatric Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy & Social Learning
Education and Support
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Abdominal Pain focused on measuring FAP, RAP, Abdominal Pain, IBS

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of North Carolina
  • Seattle Children's Hospital
  • Mary Bridge Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

SLCBT

SLCBT-R

ES

Arm Description

Social Learning and Cognitive Behavioral Therapy

Phone-based Social Learning and Cognitive Behavioral Therapy

Education and Support

Outcomes

Primary Outcome Measures

Abdominal Pain Index

Secondary Outcome Measures

Adults' Responses to Children's Symptoms
Pain Response Inventory
Pain Beliefs Questionnaire
Pain Catastrophizing Scale

Full Information

First Posted
February 14, 2012
Last Updated
April 26, 2021
Sponsor
University of Washington
Collaborators
University of North Carolina, MultiCare Mary Bridge Children's Hospital & Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01620606
Brief Title
Managing Childhood Abdominal Pain
Acronym
MCAP
Official Title
Parent Training to Address Pediatric Functional Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
University of North Carolina, MultiCare Mary Bridge Children's Hospital & Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Abdominal Pain
Keywords
FAP, RAP, Abdominal Pain, IBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLCBT
Arm Type
Experimental
Arm Description
Social Learning and Cognitive Behavioral Therapy
Arm Title
SLCBT-R
Arm Type
Experimental
Arm Description
Phone-based Social Learning and Cognitive Behavioral Therapy
Arm Title
ES
Arm Type
Active Comparator
Arm Description
Education and Support
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy & Social Learning
Intervention Description
Cognitive Behavioral Therapy & Social Learning
Intervention Type
Behavioral
Intervention Name(s)
Education and Support
Intervention Description
Education about the GI system, nutrition and food safety
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rona L Levy, MSW, MPH, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Miranda vanTilburg, PhD
Organizational Affiliation
University of North Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Mary Bridge Children's Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28301859
Citation
Levy RL, Langer SL, van Tilburg MAL, Romano JM, Murphy TB, Walker LS, Mancl LA, Claar RL, DuPen MM, Whitehead WE, Abdullah B, Swanson KS, Baker MD, Stoner SA, Christie DL, Feld AD. Brief telephone-delivered cognitive behavioral therapy targeted to parents of children with functional abdominal pain: a randomized controlled trial. Pain. 2017 Apr;158(4):618-628. doi: 10.1097/j.pain.0000000000000800.
Results Reference
derived

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Managing Childhood Abdominal Pain

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