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Managing Childhood Abdominal Pain (MCAP)

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ClinicalTrials.gov Identifier: NCT01620606
Recruitment Status : Unknown
Verified October 2015 by Rona Levy, University of Washington.
Recruitment status was:  Active, not recruiting
First Posted : June 15, 2012
Last Update Posted : October 7, 2015
Sponsor:
Collaborators:
University of North Carolina
MultiCare Mary Bridge Children's Hospital & Health Center
Information provided by (Responsible Party):
Rona Levy, University of Washington

Tracking Information
First Submitted Date  ICMJE February 14, 2012
First Posted Date  ICMJE June 15, 2012
Last Update Posted Date October 7, 2015
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Managing Childhood Abdominal Pain
Official Title  ICMJE Parent Training to Address Pediatric Functional Abdominal Pain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Abdominal Pain
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Therapy & Social Learning
    Cognitive Behavioral Therapy & Social Learning
  • Behavioral: Education and Support
    Education about the GI system, nutrition and food safety
Study Arms  ICMJE
  • Experimental: SLCBT
    Social Learning and Cognitive Behavioral Therapy
    Intervention: Behavioral: Cognitive Behavioral Therapy & Social Learning
  • Experimental: SLCBT-R
    Phone-based Social Learning and Cognitive Behavioral Therapy
    Intervention: Behavioral: Cognitive Behavioral Therapy & Social Learning
  • Active Comparator: ES
    Education and Support
    Intervention: Behavioral: Education and Support
Publications * Levy RL, Langer SL, van Tilburg MA, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 12, 2012)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01620606
Other Study ID Numbers  ICMJE CHRMC13744
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rona Levy, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • University of North Carolina
  • MultiCare Mary Bridge Children's Hospital & Health Center
Investigators  ICMJE
Principal Investigator: Rona L Levy, MSW, MPH, PhD University of Washington
Principal Investigator: Miranda vanTilburg, PhD University of North Carolina
PRS Account University of Washington
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP