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

Vomiting Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728039
• Other study ID #: 07/82
• Secondary ID: GC 399
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: October 23, 2017
• Start date: April 2007
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Vomiting
• Vomiting Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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