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Quality of Life (QOL), Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00728039
First Posted: August 5, 2008
Last Update Posted: September 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin
  Purpose
  1. Characterize the quality of life of young children with CVS (i.e., psychological, social, physical, school functioning) and the impact of the child's illness on the parent's and family's quality of life (i.e., emotional, social, cognitive functioning, communication, worry, daily activities and family relationships).
  2. Assess symptoms of depression, anxiety, ADHD and behavioral problems in what our preliminary data suggests is a psychiatrically vulnerable population.
  3. Evaluate the associations between quality of life and psychiatric symptoms and the frequency and intensity of CVS attacks.
  4. Use the data generated from this study to develop a psychosocial intervention targeted at young children with CVS and their families who evidence risk for functional disability, with the aim of intervening as early as possible to limit the psychological and social morbidity experienced by children with CVS and their and families.

Condition
Vomiting Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life, Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome

Resource links provided by NLM:


Further study details as provided by B Li, Medical College of Wisconsin:

Primary Outcome Measures:
  • Characterize the quality of life of youth with 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. [ Time Frame: Two years ]

Secondary Outcome Measures:
  • Evaluate the associations among coping strategies 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. [ Time Frame: Two years ]

Estimated Enrollment: 120
Study Start Date: April 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children aged 9-10 will complete 5 questionnaires Adolescents aged 11-18 will complete 6 questionnaires Youth aged 11-18 will fill out an additional questionnaire that asks how they cope with stress related to CVS symptoms Parents will complete 4 questionnaires
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728039


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

Responsible Party: B Li, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00728039     History of Changes
Other Study ID Numbers: 07/82
GC 399
First Submitted: July 31, 2008
First Posted: August 5, 2008
Last Update Posted: September 13, 2016
Last Verified: September 2016

Keywords provided by B Li, Medical College of Wisconsin:
Youth
Consensus
Criteria
CVS

Additional relevant MeSH terms:
Syndrome
Vomiting
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms