SVRII Family Factors Study
- Conditions
- Hypoplastic Left Heart Syndrome
- Registration Number
- NCT01582529
- Lead Sponsor
- Medical College of Wisconsin
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
- Speak English or Spanish
- Enrolled in the SVR or SVRII studies
- Have not completed the 6 year visit and questionnaires
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parental mental health During child's 6th year of life. Parental mental health will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales.
Parental quality of life During child's 6th year of life. Parental quality of life will be assessed with the Satisfaction with Health and Life Scale (SHL) (also referred to as the Perceived Quality of Life Scale).
Family resources During child's 6th year of life Family resources will be assessed with the Family Inventory of Resources for Management (FIRM.
Family function During child's 6th year of life Family function will be assessed with the Family Assessment Device (FAD)39 and the Family Management Measure (FaMM.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Children's Hospiral of Los Angeles
🇺🇸Los Angeles, California, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
The University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Nemours/Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States