Clinical trial NCT01620606: Managing Childhood Abdominal Pain
Official title: Parent Training to Address Pediatric Functional Abdominal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Abdominal Pain
Keywords: FAP
RAP
Abdominal Pain
IBS
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: MultiCare Mary Bridge Children's Hospital & Health Center
First posted: 2012-06-15
Enrollment: 316
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Abdominal Pain Index
timeFrame: 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 outcomes:
measure: Adults' Responses to Children's Symptoms
timeFrame: 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
measure: Pain Response Inventory
timeFrame: 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
measure: Pain Beliefs Questionnaire
timeFrame: 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
measure: Pain Catastrophizing Scale
timeFrame: 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
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Tacoma
country: United States
facility: Mary Bridge Children's Hospital
state: Washington
Study officials:
affiliation: University of Washington
name: Rona L Levy, MSW, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Miranda vanTilburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy RL, Langer SL, van Tilburg MAL, Romano JM, Murphy TB, Walker LS, Mancl LA, Claar RL, DuPen MM, Whitehead WE, Abdullah B, Swanson KS, Baker MD, Stoner SA, Christie DL, Feld AD. Brief telephone-delivered cognitive behavioral therapy targeted to parents of children with functional abdominal pain: a randomized controlled trial. Pain. 2017 Apr;158(4):618-628. doi: 10.1097/j.pain.0000000000000800.