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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoplastic Left Heart Syndrome

• Study Type: Observational
• Enrollment (Actual): 213

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53129
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period will be eligible to participate. Parents unable to speak or read English will be excluded. An attempt will be made to obtain consent for participation from both the mother and father of the affected infant. If no father is involved in the care of the infant, measures will be obtained from mothers alone. The model will be tested using mothers' reports of family variables. Single parents will be able to participate but will not be included in comparisons between mothers and fathers. Nurse coordinators at participating centers will conduct subject screening and consenting.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Adaptation	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.	14 months

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Medical University of South Carolina; Children's Hospital of Philadelphia; Columbia University; University of Michigan; Boston Children's Hospital; Nicklaus Children's Hospital f/k/a Miami Children's Hospital; Children's Hospital and Health System Foundation, Wisconsin; Johns Hopkins All Children's Hospital; Arkansas Children's Hospital Research Institute; American Nurses Foundation
• Investigators: Principal Investigator: Kathleen A Mussatto, PhD, RN, Children's Hospital and Health System Foundation, Wisconsin

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): September 5, 2019

Study Registration Dates

• First Submitted: August 13, 2008
• First Submitted That Met QC Criteria: August 13, 2008
• First Posted (Estimate): August 14, 2008

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Hypoplastic Left Heart Syndrome; Family coping; Complex Congenital Heart Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Syndrome; Hypoplastic Left Heart Syndrome
• Other Study ID Numbers: CHW 06/117