Web-based Management of Pediatric Functional Abdominal Pain
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Pain, Digestive Disease |
Therapuetic Areas: | Gastroenterology, Musculoskeletal |
Healthy: | No |
Age Range: | 11 - 17 |
Updated: | 3/30/2019 |
Start Date: | April 2014 |
End Date: | January 28, 2019 |
Predicting Treatment Outcomes in Pediatric Functional Abdominal Pain
Functional abdominal pain (FAP), a pediatric pain condition without significant organic
pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood.
This project aims to identify child and family characteristics that predict differential
responses to a Cognitive Behavior Therapy intervention administered online to patients with
FAP and their parents. The goal is to acquire scientific knowledge to guide individualized
treatment of patients with FAP.
pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood.
This project aims to identify child and family characteristics that predict differential
responses to a Cognitive Behavior Therapy intervention administered online to patients with
FAP and their parents. The goal is to acquire scientific knowledge to guide individualized
treatment of patients with FAP.
The goal of our research is to identify individual differences in pediatric functional
abdominal pain (FAP) that predict differential health outcomes and can be used to develop
tailored approaches to the evaluation and treatment of FAP. Effective treatment of FAP is a
critical public health issue because it is among the most common pain problems during
childhood and prospectively predicts risk for chronic pain, disability, and frequent health
service utilization (HSU) in early adulthood. Although cognitive behavior therapy (CBT)
delivered by highly trained professionals in face-to-face sessions has been found to reduce
pain in some FAP patients, such intensive resources are not generally available to the large
population of FAP patients. This study will evaluate an alternative, more efficient approach
to treating pediatric FAP. The study builds on and integrates recent work by two leading
investigators in pediatric pain. First, in a prospective natural history study of pediatric
onset FAP patients followed into late adolescence/early adulthood, PI Walker and colleagues
identified three distinct patient profiles (i.e., Low Pain Adaptive, High Pain Adaptive, High
Pain Dysfunctional) comprised of pain severity, pain cognitions, and affect at the time of
the initial FAP evaluation in childhood. These profiles predicted chronic pain and related
health outcomes at follow-up (FU) nearly a decade later. Patients with the High Pain
Dysfunctional profile at baseline had the poorest symptom outcomes and also exhibited
pro-nociceptive central pain modulation in laboratory pain testing at FU. The heterogeneity
of the FAP pain profile groups suggests that they may differ in treatment needs and in the
extent to which they benefit significantly more from adjunctive behavioral treatment as
compared to usual care alone. Second, Co-Investigator Palermo developed and tested a CBT
intervention delivered online (Web-based Management of Adolescent Pain; Web-MAP) which is an
efficient, easily disseminated treatment that significantly reduced pain and disability in
youth with a variety of chronic pain diagnoses in comparison to youth randomized to a usual
care, wait-list control group. This study merges these lines of research into an innovative
study that will, for the first time: (Aim 1) evaluate the efficacy of WebMAP administered to
FAP patients and their parents; (Aim 2) evaluate baseline moderators of treatment response,
including our previously validated FAP pain profiles, pro-nociceptive central pain
modulation, and parent characteristics (protectiveness, modeling pain behavior,
catastrophizing about the child's pain); and (Aim 3) evaluate potential mediators of the
effect of WebMAP on health outcomes. Pediatric patients (n = 300) ages 11-17 years will be
randomized to either WebMAP or a Usual Care (UC) control group following their initial
subspecialty FAP evaluation. Assessments will be at baseline, mid- and post-treatment, and at
6- and 12-months post baseline. Study results will produce knowledge that can be used to more
efficiently target interventions to FAP patients according to their individual needs and
thereby extend evidence-based care to more patients and ultimately reduce overall costs of
care.
abdominal pain (FAP) that predict differential health outcomes and can be used to develop
tailored approaches to the evaluation and treatment of FAP. Effective treatment of FAP is a
critical public health issue because it is among the most common pain problems during
childhood and prospectively predicts risk for chronic pain, disability, and frequent health
service utilization (HSU) in early adulthood. Although cognitive behavior therapy (CBT)
delivered by highly trained professionals in face-to-face sessions has been found to reduce
pain in some FAP patients, such intensive resources are not generally available to the large
population of FAP patients. This study will evaluate an alternative, more efficient approach
to treating pediatric FAP. The study builds on and integrates recent work by two leading
investigators in pediatric pain. First, in a prospective natural history study of pediatric
onset FAP patients followed into late adolescence/early adulthood, PI Walker and colleagues
identified three distinct patient profiles (i.e., Low Pain Adaptive, High Pain Adaptive, High
Pain Dysfunctional) comprised of pain severity, pain cognitions, and affect at the time of
the initial FAP evaluation in childhood. These profiles predicted chronic pain and related
health outcomes at follow-up (FU) nearly a decade later. Patients with the High Pain
Dysfunctional profile at baseline had the poorest symptom outcomes and also exhibited
pro-nociceptive central pain modulation in laboratory pain testing at FU. The heterogeneity
of the FAP pain profile groups suggests that they may differ in treatment needs and in the
extent to which they benefit significantly more from adjunctive behavioral treatment as
compared to usual care alone. Second, Co-Investigator Palermo developed and tested a CBT
intervention delivered online (Web-based Management of Adolescent Pain; Web-MAP) which is an
efficient, easily disseminated treatment that significantly reduced pain and disability in
youth with a variety of chronic pain diagnoses in comparison to youth randomized to a usual
care, wait-list control group. This study merges these lines of research into an innovative
study that will, for the first time: (Aim 1) evaluate the efficacy of WebMAP administered to
FAP patients and their parents; (Aim 2) evaluate baseline moderators of treatment response,
including our previously validated FAP pain profiles, pro-nociceptive central pain
modulation, and parent characteristics (protectiveness, modeling pain behavior,
catastrophizing about the child's pain); and (Aim 3) evaluate potential mediators of the
effect of WebMAP on health outcomes. Pediatric patients (n = 300) ages 11-17 years will be
randomized to either WebMAP or a Usual Care (UC) control group following their initial
subspecialty FAP evaluation. Assessments will be at baseline, mid- and post-treatment, and at
6- and 12-months post baseline. Study results will produce knowledge that can be used to more
efficiently target interventions to FAP patients according to their individual needs and
thereby extend evidence-based care to more patients and ultimately reduce overall costs of
care.
Inclusion Criteria:
- Referred for medical evaluation of abdominal pain of more than 3 months duration
- No prior diagnosis of organic disease that explains the pain
- Access to a computer and the internet
Exclusion Criteria:
- Presence of major medical condition (e.g., diabetes)
- Does not speak English
- Has a disability that precludes participation
- Does not have a participating parent/guardian
- Found to have significant organic disease (e.g., ulcerative colitis) in the medical
evaluation
We found this trial at
1
site
2200 Children's Way
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 936-1000
Phone: 615-936-8006
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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