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:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00728039
First received: July 31, 2008
Last updated: October 10, 2013
Last verified: October 2013
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 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:   9 Years to 18 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
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 July 22, 2014