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

March 5, 2021 updated by: Natoshia Cunningham, Michigan State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ADAPT
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
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 Names:
  • Aim to Decrease Anxiety and Pain Treatment
NO_INTERVENTION: Medical Treatment as Usual
Medical treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Disability Inventory - Child Version (FDI-C)
Time Frame: through study completion, an average of 8 weeks
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)
Time Frame: through study completion, an average of 8 weeks
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)
Time Frame: through study completion, an average of 8 weeks
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)
Time Frame: through study completion, an average of 8 weeks
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)
Time Frame: through study completion, an average of 8 weeks
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)
Time Frame: through study completion, an average of 8 weeks
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
Time Frame: through study completion, an average of 8 weeks
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)
Time Frame: through study completion, an average of 8 weeks
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)
Time Frame: through study completion, an average of 8 weeks
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)
Time Frame: through study completion, an average of 8 weeks
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)
Time Frame: through study completion, an average of 8 weeks
A validated measure of irritability in pediatric populations
through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

Children's Hospital Medical Center, Cincinnati
American Pain Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 20, 2015

Primary Completion (ACTUAL)

February 8, 2018

Study Completion (ACTUAL)

February 8, 2018

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (ACTUAL)

May 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 5, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1388

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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