Managing Childhood Abdominal Pain

NCT ID: NCT01620606

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2017-05-31

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.

Detailed Description

Functional Abdominal Pain (FAP) affects 10 to 15% of children and has significant social, emotional, and financial costs, but no known organic cause and no accepted medical or behavioral treatment. The researchers have conducted studies that provide support for a theoretical model in which cognitive-behavioral and social learning processes (modeling and/or potentially reinforcing responses by parents) may contribute to the maintenance of illness behaviors and functional disability in children with FAP. The researchers subsequently tested a social learning and cognitive-behavioral intervention for parent-child dyads which focused on changing these parent behaviors as well as teaching coping skills to children. Results support the effectiveness of the intervention and the explanatory value of the theory, demonstrating that parental change is a key element in reducing children's symptoms. The proposed study will build on these findings by evaluating a parent-only intervention. Furthermore, our experience and that of other investigators indicates that alternative intervention models are needed for wider accessibility to the intervention for families in need. While a parent-only format is expected to increase accessibility, we will also evaluate the use of a remote telephone intervention.

Conditions

Pediatric Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SLCBT

Social Learning and Cognitive Behavioral Therapy

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy & Social Learning

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy \& Social Learning

SLCBT-R

Phone-based Social Learning and Cognitive Behavioral Therapy

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy & Social Learning

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy \& Social Learning

ES

Education and Support

Group Type: ACTIVE_COMPARATOR

Education and Support

Intervention Type: BEHAVIORAL

Education about the GI system, nutrition and food safety

Interventions

Cognitive Behavioral Therapy & Social Learning

Cognitive Behavioral Therapy \& Social Learning

Intervention Type: BEHAVIORAL

Education and Support

Education about the GI system, nutrition and food safety

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

MultiCare Mary Bridge Children's Hospital & Health Center

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Rona Levy

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rona L Levy, MSW, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Miranda vanTilburg, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Seattle Children's Hospital

Seattle, Washington, United States

Mary Bridge Children's Hospital

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28301859 (View on PubMed)

Other Identifiers

13744 SCH

Identifier Type: -

Identifier Source: org_study_id