Overview

This trial is active, not recruiting.

Condition pediatric abdominal pain
Treatments cognitive behavioral therapy & social learning, education and support
Sponsor University of Washington
Collaborator University of North Carolina
Start date September 2011
End date May 2016
Trial size 300 participants
Trial identifier NCT01620606, CHRMC13744

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Social Learning and Cognitive Behavioral Therapy
cognitive behavioral therapy & social learning
Cognitive Behavioral Therapy & Social Learning
(Experimental)
Phone-based Social Learning and Cognitive Behavioral Therapy
cognitive behavioral therapy & social learning
Cognitive Behavioral Therapy & Social Learning
(Active Comparator)
Education and Support
education and support
Education about the GI system, nutrition and food safety

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 7 years up to 12 years old.

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

Additional Information

Official title Parent Training to Address Pediatric Functional Abdominal Pain
Principal investigator Rona L Levy, MSW, MPH, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Washington.