Managing Childhood Abdominal Pain

NCT01620606 | Completed DMC

• 1 other identifier: 13744 SCH
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 3

Brief Summary

Functional abdominal pain (FAP) is a common complaint of childhood, associated with considerable health care costs, disruption of normal activity, emotional distress, and long-term health effects. The study will test a treatment approach which, if successful, would substantially change the treatment for FAP and potentially for a wide range of childhood medical problems where parental responses to symptoms contribute to these adverse effects. The study would also provide a model which would be much more accessible than traditional face-to-face therapies to a broader range of families in need than are currently served.

Conditions

Pediatric Abdominal Pain

Keywords

FAP; RAP; Abdominal Pain; IBS

Outcome Measures

Primary Outcomes (1)

• Abdominal Pain Index

  Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3

Secondary Outcomes (4)

• Adults' Responses to Children's Symptoms

  Baseline, 1-3 days post treatment session 1, 1-3 days post treatment session 2,1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3

• Pain Response Inventory

  Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3

• Pain Beliefs Questionnaire

  Baseline, 1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3

• Pain Catastrophizing Scale

  Baseline, 1-3 days post treatment session 1, 1-3 days post treatment session 2,1 week post treatment session 3, 3 months post treatment session 3, 6 months post treatment session 3, 12 months post treatment session 3

Study Arms (3)

SLCBT

EXPERIMENTAL

Social Learning and Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy & Social Learning

SLCBT-R

EXPERIMENTAL

Phone-based Social Learning and Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy & Social Learning

ES

ACTIVE COMPARATOR

Education and Support

Behavioral: Education and Support

Interventions

Cognitive Behavioral Therapy & Social Learning BEHAVIORAL

Cognitive Behavioral Therapy \& Social Learning

SLCBT; SLCBT-R

Education and Support BEHAVIORAL

Education about the GI system, nutrition and food safety

ES

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child is 7 to 12 years old
• The child experienced at least three episodes of unexplained abdominal pain over a three month period which affected the child's activities
• The child lived with the primary caregiver for at least the last 3 months
• The child and the parent agree to the conditions of study participation, including randomization, participation in intervention and follow-up evaluations
• The parent and child comprehend and speak English without assistance

You may not qualify if:

• The child has positive physical or laboratory findings which would explain the abdominal pain
• The child has a chronic disease (e.g. Crohn's, ulcerative colitis, pancreatitis, diabetes, epilepsy, etc.)
• The child is lactose intolerant
• The child had major surgery in the past year
• The parent or child has developmental disabilities that require full-time special education or that impair ability to respond to assessment measures

Sponsors & Collaborators

• University of Washington: lead
• University of North Carolina: collaborator
• MultiCare Mary Bridge Children's Hospital & Health Center: collaborator

Study Sites (3)

University of North Carolina

Chapel Hill, North Carolina, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Mary Bridge Children's Hospital

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• Levy RL, Langer SL, van Tilburg MAL, Romano JM, Murphy TB, Walker LS, Mancl LA, Claar RL, DuPen MM, Whitehead WE, Abdullah B, Swanson KS, Baker MD, Stoner SA, Christie DL, Feld AD. Brief telephone-delivered cognitive behavioral therapy targeted to parents of children with functional abdominal pain: a randomized controlled trial. Pain. 2017 Apr;158(4):618-628. doi: 10.1097/j.pain.0000000000000800.

  PMID: 28301859 DERIVED

MeSH Terms

Conditions

Abdominal Pain

Interventions

Cognitive Behavioral Therapy; Educational Status; Palliative Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rona L Levy, MSW, MPH, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Miranda vanTilburg, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: June 15, 2012
• Study Start: September 1, 2011
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

US (3)