Managing Childhood Abdominal Pain

Pediatric Abdominal Pain Clinical Trial

— MCAP  

Official title:

Parent Training to Address Pediatric Functional Abdominal Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620606
• Other study ID #: 13744 SCH
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: May 2017

Study information

• Verified date: April 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Pediatric Abdominal Pain

Intervention

Behavioral:
• Cognitive Behavioral Therapy & Social Learning
Cognitive Behavioral Therapy & Social Learning
• Education and Support
Education about the GI system, nutrition and food safety

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Seattle Children's Hospital	Seattle	Washington
United States	Mary Bridge Children's Hospital	Tacoma	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	MultiCare Mary Bridge Children's Hospital & Health Center, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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