SVRII Family Factors Study

NCT ID: NCT01582529

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 187 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2019-11-14

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.

Conditions

Hypoplastic Left Heart Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Speak English or Spanish
• Enrolled in the SVR or SVRII studies

Exclusion Criteria

• Have not completed the 6 year visit and questionnaires

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital and Health System Foundation, Wisconsin

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Pediatric Heart Network

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen A Mussatto, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and Health System Foundation, Wisconsin

Locations

Children's Hospiral of Los Angeles

Los Angeles, California, United States

Nemours/Alfred I. duPont Hospital for Children

Wilmington, Delaware, United States

All Children's Hospital

St. Petersburg, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Children's Hospital Boston

Boston, Massachusetts, United States

The University of Michigan

Ann Arbor, Michigan, 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

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

U01HL068270

Identifier Type: NIH

Identifier Source: secondary_id

View Link

319498

Identifier Type: -

Identifier Source: org_study_id