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

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ClinicalTrials.gov Identifier: NCT00728039
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : October 25, 2017
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin

Tracking Information
First Submitted Date July 31, 2008
First Posted Date August 5, 2008
Last Update Posted Date October 25, 2017
Study Start Date April 2007
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 4, 2008)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life (QOL), Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome
Official Title Quality of Life, Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Vomiting Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 23, 2017)
61
Original Estimated Enrollment
 (submitted: August 4, 2008)
120
Actual Study Completion Date July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 9 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00728039
Other Study ID Numbers 07/82
GC 399
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party B Li, Medical College of Wisconsin
Study Sponsor Medical College of Wisconsin
Collaborators Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Sally E Tarbell, PhD Medical College of Wiconsin
PRS Account Medical College of Wisconsin
Verification Date October 2017