Parent Training to Address Pediatric Functional Abdominal Pain

Managing Childhood Abdominal Pain

Sponsors

Lead sponsor: University of Washington

Collaborator: University of North Carolina
MultiCare Mary Bridge Children's Hospital & Health Center

Source University of Washington
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.

Overall Status Unknown status
Start Date September 2011
Completion Date May 2016
Primary Completion Date May 2016
Phase N/A
Study Type Interventional
Primary 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
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
Enrollment 300
Condition
Intervention

Intervention type: Behavioral

Intervention name: Cognitive Behavioral Therapy & Social Learning

Description: Cognitive Behavioral Therapy & Social Learning

Intervention type: Behavioral

Intervention name: Education and Support

Description: Education about the GI system, nutrition and food safety

Arm group label: ES

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

Gender: All

Minimum age: 7 Years

Maximum age: 12 Years

Healthy volunteers: No

Overall Official
Location
facility
University of North Carolina | Chapel Hill, North Carolina, United States
Seattle Children's Hospital | Seattle, Washington, 98105, United States
Mary Bridge Children's Hospital | Tacoma, Washington, 98405, United States
Location Countries

United States

Verification Date

October 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Washington

Investigator full name: Rona Levy

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: SLCBT

Arm group type: Experimental

Description: Social Learning and Cognitive Behavioral Therapy

Arm group label: SLCBT-R

Arm group type: Experimental

Description: Phone-based Social Learning and Cognitive Behavioral Therapy

Arm group label: ES

Arm group type: Active Comparator

Description: Education and Support

Acronym MCAP
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov