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Completed

NCT Number: NCT03134950

Improving Care for Youth With FAP: A Stepped Care 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.

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Key information

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADAPT

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. Affective Reactivity Index (ARI)

    Time frame: through study completion, an average of 8 weeks

    A validated measure of irritability in pediatric populations

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • American Pain Society
  • Children's Hospital Medical Center, Cincinnati

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 1, 2017
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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