Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach

Anxiety Clinical Trial

Official title:

Improving Care for Youth With Functional Abdominal Pain: A Stepped Care Cognitive Behavioral Therapy (CBT) Delivery Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134950
• Other study ID #: 2015-1388
• Status: Completed
• Phase: N/A
• Start date: July 20, 2015
• Est. completion date: February 8, 2018

Study information

• Verified date: March 2021
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 8, 2018
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Abdominal Pain
• Anxiety
• Functional Abdominal Pain Syndrome

Intervention

Behavioral:
• ADAPT
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Michigan State University	American Pain Society, Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Disability Inventory - Child Version (FDI-C)	A 15-item self report inventory measuring perceived pain-related disability	through study completion, an average of 8 weeks
Secondary	Screen for Child Anxiety Related Disorders - Child Report (SCARED-C)	Patient-reported measure of anxiety symptoms over the past 3 months	through study completion, an average of 8 weeks
Secondary	Pain Intensity via a Visual Analog Scale (VAS)	Average pain levels in the past 2 weeks using a 0 -10 scale	through study completion, an average of 8 weeks
Secondary	Anxiety Disorder Interview Schedule - Child Version (ADIS)	A validated interview conducted by a clinician to assess for childhood psychiatric disorders, with a focus on anxiety	through study completion, an average of 8 weeks
Secondary	Child Depression Inventory 2 Self Report (CDI-2)	A self report inventory measuring symptoms of depression in children and adolescents.	through study completion, an average of 8 weeks
Secondary	Pain Catastrophizing Scale for Children, Child Version (PCS-C)	An adaptation of the Pain Catastrophizing Scale used to study coping styles among child chronic pain patients.	through study completion, an average of 8 weeks
Secondary	Functional Gastrointestinal Disorders (FGIDs) Questionnaire	This questionnaire is based off of the ROME III diagnostic criteria and is used to validate patients' FGID diagnosis. Administered by research staff.	through study completion, an average of 8 weeks
Secondary	Children's Somatization Inventory (CSI-24)	A questionnaire that assesses the perceived severity of 24 nonspecific somatic symptoms. Items are based off of the symptom criteria for somatization disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM).	through study completion, an average of 8 weeks
Secondary	Depression Anxiety Stress Scales (DASS21)	A brief self-report measure to assess parent negative-emotional states of depression, anxiety, and tension/stress.	through study completion, an average of 8 weeks
Secondary	Children's Global Assessment Scale (C-GAS)	A 0-100 scale anchored with descriptors of the patient ranging from "extremely impaired" to "doing very well". The study clinician completes the C-GAS after the completion of the ADIS.	through study completion, an average of 8 weeks
Secondary	Affective Reactivity Index (ARI)	A validated measure of irritability in pediatric populations	through study completion, an average of 8 weeks