NCT00743665

Brief Summary

The primary aim of this study is to characterize the quality of life of youth with Cyclic Vomiting Syndrome (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. The impact of CVS on the child's parent and family will also be assessed. A second aim is to evaluate the associations among coping strategies, personal strengths and vulnerabilities and 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

10.3 years

First QC Date

July 31, 2008

Last Update Submit

March 22, 2018

Conditions

Vomiting Syndrome

Keywords

YouthconsensuscriteriaCVS

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Youth who meet consensus criteria for CVS as determined by Dr. B. Li and their parents will be recruited from those being seen in the weekly outpatient CVS clinic at Children's Hospital of Wisconsin

You may qualify if:

  • Diagnosis of CVS

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sally E Tarbell, PhD

    Children's Hospital and Health System Foundation, Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 29, 2008

Study Start

June 1, 2007

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

March 23, 2018

Record last verified: 2018-03