SVRII Family Factors Study
Condition: Hypoplastic Left Heart Syndrome
MeSH terms: Hypoplastic Left Heart Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to learn about the relationship between family factors and
      developmental and psychosocial outcomes in children with congenital heart disease at 6 years
      of age. A secondary purpose is to learn more about psychosocial outcomes in children with
      congenital heart disease and their families over time.

      About 250 mothers and fathers at 15 medical centers will take part in this study; 35 will be
      from Children's Hospital of Wisconsin.
    

Detailed description: 
      Survival for one of the most complex forms of congenital heart disease (CHD), hypoplastic
      left heart syndrome (HLHS), has improved dramatically; however, survivors are known to be at
      risk for both physical and psychosocial morbidity. In congenital heart disease, this
      psychosocial morbidity has been manifested as delays in cognitive and social development,
      behavior problems, reduced quality of life, as well as parenting stress, anxiety, and
      negative impact on the family. We have a relatively limited understanding of the causes of
      psychosocial morbidity and what factors may impact risk or protection for the child and
      family.

      The environment in which a child spends the majority of their time exerts a significant
      impact on development. For infants and young children this "environment" is most commonly the
      immediate family. Interactions between illness characteristics and individual family member
      perceptions and expectations are an important determinant of the family's response to the
      presence of heart disease in a child. There is a critical gap in our understanding of how
      family-related factors influence psychosocial outcomes in the CHD population and if there are
      opportunities to intervene in order to improve outcomes for both children and families.

      The primary aim of this study is to investigate the relationship between family factors
      including, parental mental health, parental health-related quality of life (HRQOL), family
      resources, and family function, and developmental and psychosocial outcomes in children with
      HLHS at 6 years of age. Secondary aims are to explore for differences in outcomes between
      different family types and to establish the feasibility of longitudinal investigation of the
      trajectory of child and family psychosocial function over time in this well-defined cohort of
      children and parents.

      Longitudinal assessment of these family factors, in conjunction with neurodevelopmental and
      psychosocial evaluation of affected children, will provide improved understanding of how and
      when these factors influence child development. This will help to:

        -  Identify children/families at risk for problems,

        -  Elucidate the etiology and progression of psychosocial problems in children with
           congenital heart disease,

        -  Describe the relationships between child and family outcomes over time, and guide the
           development of family-focused interventions with a goal of preventing problems.

      This study will be conducted as an ancillary study to the Single Ventricle Reconstruction
      Extension Study (SVR II) conducted by the Pediatric Heart Network (PHN). All PHN study sites
      will be eligible to participate in this study. Participation will be determined by the PHN
      principal investigator at each site. Parents of children enrolled in SVR II will be eligible
      to participate in this ancillary study.

      A multivariable, descriptive design using survey techniques will be utilized. Mothers and
      fathers of children with HLHS will complete study measures at or near the SVR II 6 year
      visit. Correlation, regression, and structural equation modeling will be used to test study
      hypotheses.

      Results of this study have the potential to better define the family implications of this
      disease, the risk factors for poor outcomes and ultimately, to guide development of
      interventions to improve child and family psychosocial outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parents of subjects that are enrolled in the "Single Ventricle Reconstructive Extension
        Study" (SVR) or the SVR II study sponsored by the Pediatric Heart Network.
      
Keywords: Developmental Outcomes; Psychosocial Outcomes; Hypoplastic Left Heart Syndrome; Congenital Heart Disease