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CompletedNCT00728039Updated Oct 25, 2017

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

An observational study in Vomiting Syndrome, sponsored by Medical College of Wisconsin. Completed. Open to participants aged 9 Years to 18 Years. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by Medical College of Wisconsin · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61
Ages
9 Years to 18 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Vomiting Syndrome

Keywords

  • Youth
  • Consensus
  • Criteria
  • CVS
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 61 is below the median of 102 across 2,209 observational studies indexed under Syndrome.

Browse Syndrome studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 18 Years
Sexes eligible
All
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

Inclusion criteria

  • Diagnosis of CVS

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
61 participants (actual)
06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00728039
Lead sponsor
Medical College of Wisconsin
Collaborators
Children's Hospital and Health System Foundation, Wisconsin
Responsible party
B Li (Associate Professor, Medical College of Wisconsin) — Principal investigator
First posted
Aug 5, 2008
Start date
Apr 2007
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Oct 25, 2017

Study contacts

Sally E Tarbell, PhD
principal investigator · Medical College of Wiconsin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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