Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach
Condition: Functional Abdominal Pain Syndrome; Anxiety
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      This project aims to test a stepped care behavioral intervention approach for youth with
      functional abdominal pain (FAP) that is feasible to administer in medical settings. Screening
      and a brief intervention (i.e. psychoeducation and relaxation training) are provided to youth
      with FAP with more than minimal functional disability (FDI score >7) during their medical
      visit as part of enhanced usual care (EUC). Patients are re-assessed after two weeks. Those
      that fail to respond to EUC (as evidenced by FDI score >7) are eligible to undergo a baseline
      assessment and then are randomized to receive either 1) a more intensive and tailored CBT
      approach, Aim to Decrease Anxiety and Pain Treatment (ADAPT), provided by a trained
      psychologist, or 2) medical treatment as usual (TAU). It is hypothesized that youth who
      participate in ADAPT will have lower average pain rating scores, less pain-related functional
      disability, and less anxiety symptoms (if elevated) at post-assessment as compared to youth
      receiving medical TAU.
    

Detailed description: 
      The goal of this project is to pilot test different levels of behavioral intervention for
      patients diagnosed with FAP who are presenting for pediatric gastroenterology care. Patients
      are screened during their medical visit. Those with more than minimal levels of functional
      disability (Functional Disability Inventory (FDI) score >7), receive Enhanced Usual Care
      (EUC), brief pain-focused psychoeducation administered as part of their medical visit. As
      part of EUC, patients receive access to a web module for home use that reiterates educational
      material and offers relaxation training tools for home practice (i.e., audio recordings). Two
      weeks following EUC, patient outcomes are re-assessed with a focus on pain-related
      disability. Those who fail to respond to EUC (i.e., FDI remains >7) are invited to complete
      the next phase of the study. Eligible participants undergo a baseline assessment consisting
      of a diagnostic interview and child measures pertaining to pain, anxiety, depressive
      symptoms, and pain-related worries. Caregivers complete forms about their child's pain
      history, child disability, and child worries. Caregivers also complete a form about their own
      stress symptoms. After baseline assessment, patients are randomized to medical treatment as
      usual (TAU) or ADAPT, a tailored CBT delivered by a trained psychologist. ADAPT content
      differs based on the individual needs of the patient (i.e., all patients receive 4
      pain-focused coping skills sessions, and those who present with clinical levels of anxiety
      receive 2 additional sessions to address anxiety symptoms). Participants complete 4 or 6
      sessions (2 in person sessions and 2-4 web modules with phone support). Approximately six
      weeks after randomization, the patient and caregiver undergo follow-up assessment to assess
      pain, anxiety, and disability. It is hypothesized that youth who participate in ADAPT will
      have lower average pain rating scores, less pain-related functional disability, and lower
      levels of anxiety symptoms (if elevated) at post-assessment as compared to youth receiving
      medical TAU.
    

Intervention name(s): ADAPT
Intervention type(s): Behavioral
Intervention description(s): Aim to Decrease Anxiety and Pain Treatment is a tailored CBT ranging from 4 sessions (pain-focused) to 6 sessions (blend of pain and anxiety coping strategies depending on the needs of the individual patients. The first 2 sessions will be in person with a trained psychologist and the following 2-4 sessions will be web-based. Each web-based session will be followed by phone support.
Other intervention name(s): Aim to Decrease Anxiety and Pain Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment