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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Functional Abdominal Pain Syndrome, Anxiety

Intervention / Treatment
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* Behavioral: ADAPT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADAPT<br>Aim to Decrease Anxiety and Pain Treatment (ADAPT) 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 are in person with a trained psychologist and the following 2-4 sessions are web-based. Each web-based session is followed by phone support. | Behavioral: ADAPT<br>* 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.<br>* Other names: Aim to Decrease Anxiety and Pain Treatment;|
| No Intervention: Medical Treatment as Usual<br>Medical treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Affective Reactivity Index (ARI) | A validated measure of irritability in pediatric populations | through study completion, an average of 8 weeks |