Quality of Life (QOL), Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome
This study is enrolling participants by invitation only.
Sponsor:
Medical College of Wisconsin
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00728039
First received: July 31, 2008
Last updated: July 15, 2009
Last verified: July 2009
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Purpose
- 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.
| Condition |
|---|
|
Vomiting Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Quality of Life, Coping and Psychological Symptoms in Children and Adolescents With Cyclic Vomiting Syndrome |
Resource links provided by NLM:
Further study details as provided by Medical College of Wisconsin:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2009 |
Eligibility| Ages Eligible for Study: | 9 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sally Tarbell, PhD, Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00728039 History of Changes |
| Other Study ID Numbers: | 07/82, GC 399 |
| Study First Received: | July 31, 2008 |
| Last Updated: | July 15, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medical College of Wisconsin:
|
Youth Consensus Criteria CVS |
Additional relevant MeSH terms:
|
Vomiting Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013