Clinical Trial: Family Adaptation Study Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Family Stress, Coping and Outcomes Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn

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 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.

Hypotheses:

  1. 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.
  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 Summary:
Sponsor: Medical College of Wisconsin

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medical College of Wisconsin

Dates:
Date Received: August 13, 2008
Date Started: June 2006
Date Completion: December 2018
Last Updated: February 10, 2017
Last Verified: February 2017