SVRII Family Factors Study



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 60
Updated:3/9/2019
Start Date:June 2012
End Date:December 2019

Use our guide to learn which trials are right for you!

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 Single Ventricle Reconstruction Extension (SVR II) Ancillary Study

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.

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.

Inclusion Criteria:

- Speak English or Spanish

- Enrolled in the SVR or SVRII studies

Exclusion Criteria:

- Have not completed the 6 year visit and questionnaires
We found this trial at
11
sites
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Los Angeles, California 90027
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
555 University Avenue
Toronto, Ontario M5G 1X8
?
mi
from
Toronto,
Click here to add this to my saved trials
?
mi
from
Wilmington, DE
Click here to add this to my saved trials