Managing Childhood Abdominal Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parent Training to Address Pediatric Functional Abdominal Pain

Conditions
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Pediatric Abdominal Pain

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy & Social Learning
* Behavioral: Education and Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLCBT<br>Social Learning and Cognitive Behavioral Therapy | Behavioral: Cognitive Behavioral Therapy & Social Learning<br>* Cognitive Behavioral Therapy & Social Learning<br>|
| Experimental: SLCBT-R<br>Phone-based Social Learning and Cognitive Behavioral Therapy | Behavioral: Cognitive Behavioral Therapy & Social Learning<br>* Cognitive Behavioral Therapy & Social Learning<br>|
| Active Comparator: ES<br>Education and Support | Behavioral: Education and Support<br>* Education about the GI system, nutrition and food safety<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FAP, RAP, Abdominal Pain, IBS