Overview

This trial is active, not recruiting.

Condition hypoplastic left heart syndrome
Sponsor Medical College of Wisconsin
Collaborator Children's Hospital and Health System Foundation, Wisconsin
Start date June 2006
End date December 2015
Trial size 130 participants
Trial identifier NCT00734643, CHW 06/117

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Family Adaptation
time frame: 14 months

Eligibility Criteria

Male or female participants up to 3 years old.

Inclusion Criteria: - Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period Exclusion Criteria: - Parents unable to speak or read English

Additional Information

Official title Family Stress, Coping and Outcomes Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn
Principal investigator Kathleen A Mussatto, PhD, RN
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.