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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital and Health System Foundation, Wisconsin
Florida International University
Columbia University
Children's Hospital Boston
University of Michigan
Children's Hospital of Philadelphia
All Children’s Hospital Johns Hopkins Medicine
Medical University of South Carolina
Arkansas Children's Hospital Research Institute
Miami Children's Hospital
Information provided by (Responsible Party):
Kathleen Mussatto, Children's Hospital and Health System Foundation, Wisconsin
ClinicalTrials.gov Identifier:
NCT00734643
First received: August 13, 2008
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.

Condition
Hypoplastic Left Heart Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Family Stress, Coping and Outcomes Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Family Adaptation [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 130
Study Start Date: June 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734643

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53129
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Florida International University
Columbia University
Children's Hospital Boston
University of Michigan
Children's Hospital of Philadelphia
All Children’s Hospital Johns Hopkins Medicine
Medical University of South Carolina
Arkansas Children's Hospital Research Institute
Miami Children's Hospital
Investigators
Principal Investigator: Kathleen A Mussatto, PhD, RN Children's Hospital and Health System Foundation, Wisconsin
  More Information

No publications provided

Responsible Party: Kathleen Mussatto, Nurse Scientist, Children's Hospital and Health System Foundation, Wisconsin
ClinicalTrials.gov Identifier: NCT00734643     History of Changes
Other Study ID Numbers: CHW 06/117
Study First Received: August 13, 2008
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Hypoplastic Left Heart Syndrome
Family coping
Complex Congenital Heart Disease

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014