Ignite Creation Date:
2024-05-05 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00734643
Status:
COMPLETED
Last Update Posted:
2020-01-29
First Post:
2008-08-13
Brief Title:
Family Adaptation Study Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Family Stress Coping and Outcomes Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Survival for one of the most complex forms of congenital heart disease hypoplastic left heart syndrome HLHS has improved dramatically However little is known about family stress coping and outcomes following the diagnosis of HLHS It is expected that families face emotional social and financial stressors Health care professionals have a unique opportunity to positively influence how families interpret and adapt to these stressors The specific aims of the study are to describe perceived stress and coping skills utilized in parents of children with HLHS and their impact on family outcomes measured as well-being adaptation and caregiverfamily quality of life and to describe changes in stress coping and adaptation and differences in perceptions of mothers versus fathers of children with HLHS over the first 14 months of life The Resiliency Model of Family Adjustment and Adaptation McCubbin Thompson McCubbin 1996 is the theoretical framework that guides this research
Hypotheses
1 Family perception of stress and coping skills utilized will have an impact on family outcomes measured as well-being adaptation and caregiverfamily quality of life
2 Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes
3 Perceptions of stress coping skills utilized and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS
4 Mothers and fathers will report different perceptions of stress coping skills utilized and family adaptation outcomes during the first 14 months of life with an infant with HLHS
Hypotheses
1 Family perception of stress and coping skills utilized will have an impact on family outcomes measured as well-being adaptation and caregiverfamily quality of life
2 Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes
3 Perceptions of stress coping skills utilized and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS
4 Mothers and fathers will report different perceptions of stress coping skills utilized and family adaptation outcomes during the first 14 months of life with an infant with HLHS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None