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SVRII Family Factors Study
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| First Received Date ICMJE | April 19, 2012 | ||||||||
| Last Updated Date | February 10, 2017 | ||||||||
| Start Date ICMJE | June 2012 | ||||||||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01582529 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | SVRII Family Factors Study | ||||||||
| Official Title ICMJE | The Impact of Family Factors on Developmental and Psychosocial Outcomes in Children With Hypoplastic Left Heart Syndrome (HLHS) at 6 Years of Age - Pediatric Heart Network Single Ventricle Reconstruction Extension (SVR II) Ancillary Study | ||||||||
| Brief Summary | The purpose of this study is to learn about the relationship between family factors and developmental and psychosocial outcomes in children with congenital heart disease at 6 years of age. A secondary purpose is to learn more about psychosocial outcomes in children with congenital heart disease and their families over time. About 250 mothers and fathers at 15 medical centers will take part in this study; 35 will be from Children's Hospital of Wisconsin. |
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| Detailed Description | Survival for one of the most complex forms of congenital heart disease (CHD), hypoplastic left heart syndrome (HLHS), has improved dramatically; however, survivors are known to be at risk for both physical and psychosocial morbidity. In congenital heart disease, this psychosocial morbidity has been manifested as delays in cognitive and social development, behavior problems, reduced quality of life, as well as parenting stress, anxiety, and negative impact on the family. We have a relatively limited understanding of the causes of psychosocial morbidity and what factors may impact risk or protection for the child and family. The environment in which a child spends the majority of their time exerts a significant impact on development. For infants and young children this "environment" is most commonly the immediate family. Interactions between illness characteristics and individual family member perceptions and expectations are an important determinant of the family's response to the presence of heart disease in a child. There is a critical gap in our understanding of how family-related factors influence psychosocial outcomes in the CHD population and if there are opportunities to intervene in order to improve outcomes for both children and families. The primary aim of this study is to investigate the relationship between family factors including, parental mental health, parental health-related quality of life (HRQOL), family resources, and family function, and developmental and psychosocial outcomes in children with HLHS at 6 years of age. Secondary aims are to explore for differences in outcomes between different family types and to establish the feasibility of longitudinal investigation of the trajectory of child and family psychosocial function over time in this well-defined cohort of children and parents. Longitudinal assessment of these family factors, in conjunction with neurodevelopmental and psychosocial evaluation of affected children, will provide improved understanding of how and when these factors influence child development. This will help to:
This study will be conducted as an ancillary study to the Single Ventricle Reconstruction Extension Study (SVR II) conducted by the Pediatric Heart Network (PHN). All PHN study sites will be eligible to participate in this study. Participation will be determined by the PHN principal investigator at each site. Parents of children enrolled in SVR II will be eligible to participate in this ancillary study. A multivariable, descriptive design using survey techniques will be utilized. Mothers and fathers of children with HLHS will complete study measures at or near the SVR II 6 year visit. Correlation, regression, and structural equation modeling will be used to test study hypotheses. Results of this study have the potential to better define the family implications of this disease, the risk factors for poor outcomes and ultimately, to guide development of interventions to improve child and family psychosocial outcomes. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Parents of subjects that are enrolled in the "Single Ventricle Reconstructive Extension Study" (SVR) or the SVR II study sponsored by the Pediatric Heart Network. | ||||||||
| Condition ICMJE | Hypoplastic Left Heart Syndrome | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 250 | ||||||||
| Estimated Completion Date | December 2018 | ||||||||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 60 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Canada, United States | ||||||||
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| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01582529 | ||||||||
| Other Study ID Numbers ICMJE | 319498 U01HL068270 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Kathleen Mussatto, Children's Hospital and Health System Foundation, Wisconsin | ||||||||
| Study Sponsor ICMJE | Medical College of Wisconsin | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Medical College of Wisconsin | ||||||||
| Verification Date | February 2017 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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