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Clinical Trials/NCT00728039
NCT00728039
Completed
Not Applicable

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

Medical College of Wisconsin0 sites61 target enrollmentApril 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vomiting Syndrome
Sponsor
Medical College of Wisconsin
Enrollment
61
Primary Endpoint
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.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

  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.
Registry
clinicaltrials.gov
Start Date
April 2007
End Date
July 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

B Li

Associate Professor

Medical College of Wisconsin

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • 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.(Two years)

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