Web-based Management of Pediatric Functional Abdominal Pain
Condition: Gastrointestinal Disorders, Functional
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Abdominal Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Online Cognitive Behavior Therapy; Online Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable bowel syndrome; Intervention studies; Visceral pain; Chronic pain; Abdominal pain; Dyspepsia; Nausea; Nociception; Parents; Coping behavior; Anxiety; Depression; Catastrophization; Reinforcement (psychology); Self efficacy; Health services overutilization; Questionnaires; Self report; Health surveys; Prospective studies; Adolescent health; Mental health services; Health services accessibility; Health diaries; National Institute of Child Health & Human Development (US.); Telemedicine; E-Health; Web-based intervention; Parenting education