Managing Childhood Abdominal Pain

Not Applicable

Completed

Interventions: Behavioral: Cognitive Behavioral Therapy & Social Learning
Behavioral: Education and Support

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
SLCBT	Cognitive Behavioral Therapy & Social Learning	Social Learning and Cognitive Behavioral Therapy
ES	Education and Support	Education and Support
SLCBT-R	Cognitive Behavioral Therapy & Social Learning	Phone-based Social Learning and Cognitive Behavioral Therapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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

Locations (3): Seattle Children's Hospital
🇺🇸
Seattle, Washington, United States
Mary Bridge Children's Hospital
🇺🇸
Tacoma, Washington, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States