Managing Childhood Abdominal Pain (MCAP)

Parent Training to Address Pediatric Functional Abdominal Pain

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Abdominal Pain
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy & Social Learning; Behavioral: Education and Support

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.

• Study Type: Interventional
• Enrollment (Actual): 316
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • University of North Carolina
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Tacoma, Washington, United States, 98405
      • Mary Bridge Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Abdominal Pain Index	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

Outcome Measure	Time Frame
Adults' Responses to Children's Symptoms	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 14, 2012
• First Submitted That Met QC Criteria: June 12, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Abdominal Pain; IBS; FAP; RAP
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: 13744 SCH