Family Adaptation Study Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn
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|ClinicalTrials.gov Identifier: NCT00734643|
Recruitment Status : Active, not recruiting
First Posted : August 14, 2008
Last Update Posted : March 1, 2018
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 caregiver/family 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.
- Family perception of stress, and coping skills utilized, will have an impact on family outcomes measured as well-being, adaptation, and caregiver/family quality of life.
- Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes.
- Perceptions of stress, coping skills utilized, and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS.
- 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.
|Condition or disease|
|Hypoplastic Left Heart Syndrome|
|Study Type :||Observational|
|Actual Enrollment :||213 participants|
|Official Title:||Family Stress, Coping and Outcomes Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- Family Adaptation [ Time Frame: 14 months ]Family adaptation will be measured with the general functioning scale of the Family Assessment Device (FAD) (Miller, Epstein, Bishop & Keitner, 1985) at T1, T2 and T3. The FAD provides an overall measure of family functioning; 12 items, reliability alpha = .83-.86.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734643
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53129|
|Principal Investigator:||Kathleen A Mussatto, PhD, RN||Children's Hospital and Health System Foundation, Wisconsin|