Quality of Life And Psychological Symptoms In Children With Cyclic Vomiting Syndrome (CVS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00743665
First received: July 31, 2008
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

The primary aim of this study is to characterize the quality of life of youth with Cyclic Vomiting Syndrome (CVS) as well as the strategies they use to cope with stress, their strengths and vulnerabilities, and to assess symptoms of depression and anxiety in these at risk youth. The impact of CVS on the child's parent and family will also be assessed.

A second aim is to evaluate the associations among coping strategies, personal strengths and vulnerabilities and the frequency and intensity of CVS attacks to determine if particular coping styles and personal characteristics are associated illness severity, psychiatric co-morbidity and quality of life


Condition
Vomiting Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life And Psychological Symptoms In Children With Cyclic Vomiting Syndrome

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Estimated Enrollment: 75
Study Start Date: June 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Youth who meet consensus criteria for CVS as determined by Dr. B. Li and their parents will be recruited from those being seen in the weekly outpatient CVS clinic at Children's Hospital of Wisconsin

Criteria

Inclusion Criteria:

  • Diagnosis of CVS

Exclusion Criteria:

  • Children and parents who are not English speaking
  • Youth with significant developmental delay, mental retardation, psychotic symptoms, or other significant mental impairments and those with other major medical disorders such as IDDM, congenital heart disease, cystic fibrosis, etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743665

Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Sally E Tarbell, PhD Children's Hospital and Health System Foundation, Wisconsin
  More Information

No publications provided

Responsible Party: B Li, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00743665     History of Changes
Other Study ID Numbers: 07/130, GC 463
Study First Received: July 31, 2008
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Youth
consensus
criteria
CVS

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014