Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach
Completed · Not applicable
Conditions studied: Functional Abdominal Pain Syndrome, Anxiety
In brief
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.
Key facts
- Study ID
- NCT03134950
- Run by
- Michigan State University
- People needed
- 139
- Starts
- 2015-07-20
- Expected to finish
- 2018-02-08
- Last updated by the study team
- 2021-03-09
Who can join
Age: 9 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- diagnosed with functional abdominal pain by a pediatric gastroenterologist
- clinically significant disability evidenced by a total score of > 7 on the Functional Disability Inventory (FDI) that remains elevated (>2) after 2 weeks
You may not qualify if…
- significant medical condition(s) with an identifiable organic cause (e.g., Inflammatory Bowel Diseases such as Ulcerative Colitis and Chron's Disease)
- documented developmental delay, severe cognitive impairment, or a thought disorder
- evidence of severe depressive symptoms (CDI 2: T score >80) and/or active suicidal ideation
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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