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

Primary Purpose

Functional Abdominal Pain Syndrome, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADAPT
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Abdominal Pain Syndrome

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ADAPT

Medical Treatment as Usual

Arm Description

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.

Medical treatment as usual

Outcomes

Primary Outcome Measures

Functional Disability Inventory - Child Version (FDI-C)
A 15-item self report inventory measuring perceived pain-related disability

Secondary Outcome Measures

Screen for Child Anxiety Related Disorders - Child Report (SCARED-C)
Patient-reported measure of anxiety symptoms over the past 3 months
Pain Intensity via a Visual Analog Scale (VAS)
Average pain levels in the past 2 weeks using a 0 -10 scale
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
Child Depression Inventory 2 Self Report (CDI-2)
A self report inventory measuring symptoms of depression in children and adolescents.
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.
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.
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).
Depression Anxiety Stress Scales (DASS21)
A brief self-report measure to assess parent negative-emotional states of depression, anxiety, and tension/stress.
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.
Affective Reactivity Index (ARI)
A validated measure of irritability in pediatric populations

Full Information

First Posted
April 12, 2017
Last Updated
March 5, 2021
Sponsor
Michigan State University
Collaborators
American Pain Society, Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03134950
Brief Title
Improving Care for Youth With FAP: A Stepped Care CBT Delivery Approach
Official Title
Improving Care for Youth With Functional Abdominal Pain: A Stepped Care Cognitive Behavioral Therapy (CBT) Delivery Approach
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2015 (Actual)
Primary Completion Date
February 8, 2018 (Actual)
Study Completion Date
February 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
American Pain Society, Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Abdominal Pain Syndrome, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADAPT
Arm Type
Experimental
Arm Description
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.
Arm Title
Medical Treatment as Usual
Arm Type
No Intervention
Arm Description
Medical treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
ADAPT
Other Intervention Name(s)
Aim to Decrease Anxiety and Pain Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional Disability Inventory - Child Version (FDI-C)
Description
A 15-item self report inventory measuring perceived pain-related disability
Time Frame
through study completion, an average of 8 weeks
Secondary Outcome Measure Information:
Title
Screen for Child Anxiety Related Disorders - Child Report (SCARED-C)
Description
Patient-reported measure of anxiety symptoms over the past 3 months
Time Frame
through study completion, an average of 8 weeks
Title
Pain Intensity via a Visual Analog Scale (VAS)
Description
Average pain levels in the past 2 weeks using a 0 -10 scale
Time Frame
through study completion, an average of 8 weeks
Title
Anxiety Disorder Interview Schedule - Child Version (ADIS)
Description
A validated interview conducted by a clinician to assess for childhood psychiatric disorders, with a focus on anxiety
Time Frame
through study completion, an average of 8 weeks
Title
Child Depression Inventory 2 Self Report (CDI-2)
Description
A self report inventory measuring symptoms of depression in children and adolescents.
Time Frame
through study completion, an average of 8 weeks
Title
Pain Catastrophizing Scale for Children, Child Version (PCS-C)
Description
An adaptation of the Pain Catastrophizing Scale used to study coping styles among child chronic pain patients.
Time Frame
through study completion, an average of 8 weeks
Title
Functional Gastrointestinal Disorders (FGIDs) Questionnaire
Description
This questionnaire is based off of the ROME III diagnostic criteria and is used to validate patients' FGID diagnosis. Administered by research staff.
Time Frame
through study completion, an average of 8 weeks
Title
Children's Somatization Inventory (CSI-24)
Description
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).
Time Frame
through study completion, an average of 8 weeks
Title
Depression Anxiety Stress Scales (DASS21)
Description
A brief self-report measure to assess parent negative-emotional states of depression, anxiety, and tension/stress.
Time Frame
through study completion, an average of 8 weeks
Title
Children's Global Assessment Scale (C-GAS)
Description
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.
Time Frame
through study completion, an average of 8 weeks
Title
Affective Reactivity Index (ARI)
Description
A validated measure of irritability in pediatric populations
Time Frame
through study completion, an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natoshia Cunningham, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34902549
Citation
Kalomiris AE, Ely SL, Love SC, Mara CA, Cunningham NR. Child-Focused Cognitive Behavioral Therapy for Pediatric Abdominal Pain Disorders Reduces Caregiver Anxiety in Randomized Clinical Trial. J Pain. 2022 May;23(5):810-821. doi: 10.1016/j.jpain.2021.12.001. Epub 2021 Dec 11.
Results Reference
derived
PubMed Identifier
33130153
Citation
Cunningham NR, Kalomiris A, Peugh J, Farrell M, Pentiuk S, Mallon D, Le C, Moorman E, Fussner L, Dutta RA, Kashikar-Zuck S. Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial. J Pediatr. 2021 Mar;230:62-70.e3. doi: 10.1016/j.jpeds.2020.10.060. Epub 2020 Oct 31.
Results Reference
derived

Learn more about this trial

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

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