This trial is active, not recruiting.

Condition vomiting syndrome
Sponsor Medical College of Wisconsin
Collaborator Children's Hospital and Health System Foundation, Wisconsin
Start date April 2007
End date December 2016
Trial size 120 participants
Trial identifier NCT00728039, 07/82, GC 399


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

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

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

Eligibility Criteria

Male or female participants from 9 years up to 18 years old.

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.

Additional Information

Official title Quality of Life, Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome
Principal investigator Sally E Tarbell, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.