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

August 13, 2008
July 31, 2013
June 2006
December 2013   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00734643 on ClinicalTrials.gov Archive Site
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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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

Hypoplastic Left Heart Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00734643
CHW 06/117
No
Kathleen Mussatto, Children's Hospital and Health System Foundation, Wisconsin
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
Principal Investigator: Kathleen A Mussatto, PhD, RN Children's Hospital and Health System Foundation, Wisconsin
Medical College of Wisconsin
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP