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

NCT ID: NCT00728039

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Vomiting Syndrome

Keywords

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Youth Consensus Criteria CVS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role collaborator

Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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B Li

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sally E Tarbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wiconsin

Countries

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United States

Other Identifiers

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GC 399

Identifier Type: -

Identifier Source: secondary_id

07/82

Identifier Type: -

Identifier Source: org_study_id