SVRII Family Factors Study
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
2 other identifiers
observational
187
2 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2019
CompletedJanuary 22, 2020
January 1, 2020
7.5 years
April 19, 2012
January 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Parental mental health
Parental mental health will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales.
During child's 6th year of life.
Parental quality 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).
During child's 6th year of life.
Family resources
Family resources will be assessed with the Family Inventory of Resources for Management (FIRM.
During child's 6th year of life
Family function
Family function will be assessed with the Family Assessment Device (FAD)39 and the Family Management Measure (FaMM.
During child's 6th year of life
Eligibility Criteria
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.
You may qualify if:
- Speak English or Spanish
- Enrolled in the SVR or SVRII studies
You may not qualify if:
- Have not completed the 6 year visit and questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical College of Wisconsinlead
- Children's Hospital and Health System Foundation, Wisconsincollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Pediatric Heart Networkcollaborator
Study Sites (11)
Children's Hospiral of Los Angeles
Los Angeles, California, 90027, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
The University of Michigan
Ann Arbor, Michigan, 48109, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84132, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen A Mussatto, PhD, RN
Children's Hospital and Health System Foundation, Wisconsin
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2012
First Posted
April 20, 2012
Study Start
June 1, 2012
Primary Completion
November 14, 2019
Study Completion
November 14, 2019
Last Updated
January 22, 2020
Record last verified: 2020-01