Clinical Trial: SVRII Family Factors Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: The Impact of Family Factors on Developmental and Psychosocial Outcomes in Children With Hypoplastic Left Heart Syndrome (HLHS) at 6 Years of Age - Pediatric Heart Network
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 Summary:
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.
Current Primary Outcome:
- Parental mental health [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During child's 6th year of life ]Family resources will be assessed with the Family Inventory of Resources for Management (FIRM.
- Family function [ Time Frame: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medical College of Wisconsin
Dates:
Date Received: April 19, 2012
Date Started: June 2012
Date Completion: December 2018
Last Updated: February 10, 2017
Last Verified: February 2017
