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

NCT03134950 | Completed

• 1 other identifier: 2015-1388
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Abdominal Pain Syndrome; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Screen for Child Anxiety Related Disorders - Child Report (SCARED-C)

  through study completion, an average of 8 weeks

• Pain Intensity via a Visual Analog Scale (VAS)

  through study completion, an average of 8 weeks

• Anxiety Disorder Interview Schedule - Child Version (ADIS)

  through study completion, an average of 8 weeks

• Child Depression Inventory 2 Self Report (CDI-2)

  through study completion, an average of 8 weeks

• Pain Catastrophizing Scale for Children, Child Version (PCS-C)

  through study completion, an average of 8 weeks

Study Arms (2)

ADAPT

EXPERIMENTAL

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

Medical Treatment as Usual

NO INTERVENTION

Medical treatment as usual

Interventions

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.

Also known as: Aim to Decrease Anxiety and Pain Treatment

ADAPT

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead
• American Pain Society: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

• 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.

  PMID: 34902549 DERIVED

• 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.

  PMID: 33130153 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Natoshia Cunningham, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: May 1, 2017
• Study Start: July 20, 2015
• Primary Completion: February 8, 2018
• Study Completion: February 8, 2018
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

US (1)