Quality of Life (QOL), Coping and Psychological Symptoms... | NCT00728039

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

NCT00728039

Sponsor

Medical College of Wisconsin

Status

Completed

Last Update Posted

Oct 25, 2017Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Vomiting Syndrome

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GC 399

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Jul 31, 2008

First Submission Date that Met QC Criteria

Aug 4, 2008

First Posted Date

Aug 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2017

Last Update Posted Date

Oct 25, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

B Li, Associate Professor, Medical College of WisconsinPrincipal Investigator

Lead Sponsor

Medical College of WisconsinOTHER

Collaborators

Name	Class
Children's Hospital and Health System Foundation, Wisconsin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).
Assess symptoms of depression, anxiety, ADHD and behavioral problems in what our preliminary data suggests is a psychiatrically vulnerable population.
Evaluate the associations between quality of life and psychiatric symptoms and the frequency and intensity of CVS attacks.
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		Two years

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sally E Tarbell, PhD	Medical College of Wiconsin	Principal Investigator

Locations

Not provided