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

Purpose

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).
Assess symptoms of depression, anxiety, ADHD and behavioral problems in what our preliminary data suggests is a psychiatrically vulnerable population.
Evaluate the associations between quality of life and psychiatric symptoms and the frequency and intensity of CVS attacks.
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

MedlinePlus related topics:

Depression Nausea and Vomiting

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Quality of Life, Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	120
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2009

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728039

Locations


United States, Wisconsin
	Children's Hospital of Wisconsin
	Milwaukee, Wisconsin, United States, 53226

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:	Medical College of Wisconsin ( Sally Tarbell, PhD )
Study ID Numbers:	07/82, GC 399
First Received:	July 31, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00728039
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:

Youth

Consensus

Criteria

CVS

Study placed in the following topic categories:

Signs and Symptoms

Vomiting

Signs and Symptoms, Digestive

Cyclic vomiting syndrome

Quality of Life

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	Medical College of Wisconsin Children's Hospital and Health System Foundation, Wisconsin
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00728039