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

NCT ID: NCT00734643

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 213 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2019-09-05

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.

Conditions

Hypoplastic Left Heart Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role: collaborator

American Nurses Foundation

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

Johns Hopkins All Children's Hospital

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role: collaborator

Nicklaus Children's Hospital f/k/a Miami Children's Hospital

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen A Mussatto, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and Health System Foundation, Wisconsin

Locations

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

CHW 06/117

Identifier Type: -

Identifier Source: org_study_id