Managing Childhood Abdominal Pain (MCAP)

University of Washington

Status: Completed

Conditions: Pediatric Abdominal Pain

Treatments: Behavioral: Cognitive Behavioral Therapy & Social Learning; Behavioral: Education and Support

Study type: Interventional

Funder types: Other

Identifiers

NCT01620606

13744 SCH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 316 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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316 participants in 3 patient groups

SLCBT

Experimental group

Description:

Social Learning and Cognitive Behavioral Therapy

Treatment:

Behavioral: Cognitive Behavioral Therapy & Social Learning

SLCBT-R

Experimental group

Description:

Phone-based Social Learning and Cognitive Behavioral Therapy

Treatment:

Behavioral: Cognitive Behavioral Therapy & Social Learning

ES

Active Comparator group

Description:

Education and Support

Treatment:

Behavioral: Education and Support