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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00728039
First received: July 31, 2008
Last updated: July 15, 2009
Last verified: July 2009
History of Changes

July 31, 2008
July 15, 2009
April 2007
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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 ]
Same as current
Complete list of historical versions of study NCT00728039 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Quality of Life (QOL), Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome
Quality of Life, Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome
  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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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
Vomiting Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
April 2009
Not Provided

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.
Both
9 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00728039
07/82, GC 399
No
Sally Tarbell, PhD, Medical College of Wisconsin
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Principal Investigator: Sally E Tarbell, PhD Medical College of Wiconsin
Medical College of Wisconsin
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP