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SVRII Family Factors Study

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ClinicalTrials.gov Identifier: NCT01582529
Recruitment Status : Recruiting
First Posted : April 20, 2012
Last Update Posted : February 13, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Hypoplastic Left Heart Syndrome

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.

Study Design

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : June 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parents of subjects that are enrolled in the "Single Ventricle Reconstructive Extension Study" (SVR) or the SVR II study sponsored by the Pediatric Heart Network.

Inclusion Criteria:

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

Exclusion Criteria:

  • Have not completed the 6 year visit and questionnaires
Contacts and Locations

Information from the National Library of Medicine

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

Contact: Michelle Otto, BA 414-266-6154 motto2@chw.org
Contact: Mara C Koffarnus, MA 414-266-4758 mkoffarnus@chw.org

United States, California
Children's Hospiral of Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Hesham Mahmoud       HMahmoud@chla.usc.edu   
United States, Delaware
Nemours/Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
United States, Florida
All Children's Hospital Recruiting
St. Petersburg, Florida, United States, 33701
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30329
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Michelle Robinson       Michelle.Robinson@imail.org   
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
Principal Investigator: Kathleen A Mussatto, PhD, RN Children's Hospital and Health System Foundation, Wisconsin
More Information

Responsible Party: Kathleen Mussatto, Nurse Scientist, Children's Hospital and Health System Foundation, Wisconsin
ClinicalTrials.gov Identifier: NCT01582529     History of Changes
Other Study ID Numbers: 319498
U01HL068270 ( U.S. NIH Grant/Contract )
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

Keywords provided by Kathleen Mussatto, Children's Hospital and Health System Foundation, Wisconsin:
Developmental Outcomes
Psychosocial Outcomes
Hypoplastic Left Heart Syndrome
Congenital Heart Disease

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities