Pediatric Abdominal Pain
Conditions
Keywords
FAP, RAP, Abdominal Pain, IBS
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy & Social Learning
Cognitive Behavioral Therapy & Social Learning
BEHAVIORALEducation and Support
Education about the GI system, nutrition and food safety
Sponsors
University of North Carolina
MultiCare Mary Bridge Children's Hospital & Health Center
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed