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

NCT00728039 | Completed

• 2 other identifiers: 07/82GC 399
• Study Type: observational
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.Assess symptoms of depression, anxiety, ADHD and behavioral problems in what our preliminary data suggests is a psychiatrically vulnerable population.
3. 3.Evaluate the associations between quality of life and psychiatric symptoms and the frequency and intensity of CVS attacks.
4. 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.

Conditions

Vomiting Syndrome

Keywords

Youth; Consensus; Criteria; CVS

Outcome Measures

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.

  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.

  Two years

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Officials

• Sally E Tarbell, PhD

  Medical College of Wiconsin

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 5, 2008
• Study Start: April 1, 2007
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10