SVRII Family Factors Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01582529|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2012
Last Update Posted : March 1, 2018
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.
|Condition or disease|
|Hypoplastic Left Heart Syndrome|
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.
|Study Type :||Observational|
|Actual Enrollment :||187 participants|
|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 Single Ventricle Reconstruction Extension (SVR II) Ancillary Study|
|Actual Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582529
|United States, California|
|Children's Hospiral of Los Angeles|
|Los Angeles, California, United States, 90027|
|United States, Delaware|
|Nemours/Alfred I. duPont Hospital for Children|
|Wilmington, Delaware, United States, 19803|
|United States, Florida|
|All Children's Hospital|
|Saint Petersburg, Florida, United States, 33701|
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30329|
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Utah|
|Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84132|
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Kathleen A Mussatto, PhD, RN||Children's Hospital and Health System Foundation, Wisconsin|