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OpenTrials
Completed

NCT Number: NCT01620606

Managing Childhood Abdominal Pain

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cognitive Behavioral Therapy & Social Learning

Behavioral

Cognitive Behavioral Therapy & Social Learning

Education and Support

Behavioral

Education about the GI system, nutrition and food safety

Primary outcomes

  1. Abdominal Pain Index

    Time frame: 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

  1. Adults' Responses to Children's Symptoms

    Time frame: 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

  2. Pain Response Inventory

    Time frame: 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

  3. Pain Beliefs Questionnaire

    Time frame: 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

  4. Pain Catastrophizing Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • MultiCare Mary Bridge Children's Hospital & Health Center
  • University of North Carolina

Registry information

Official study title

Parent Training to Address Pediatric Functional Abdominal Pain

Acronym: MCAP

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2012
Registry last updated
Apr 27, 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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