Parenting After Infant Congenital Heart Defect Diagnosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital and Health System Foundation, Wisconsin
University of Wisconsin, Madison
Information provided by (Responsible Party):
Karen Pridham, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01503307
First received: December 28, 2011
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

The purpose of this research study is to learn about the experience that parents of babies with a Congenital Heart Defect (CHD) have after learning the baby has a heart defect. Doctors, nurses, and other health-care clinicians need to learn about what the diagnosis means to parents and what they expect concerning the baby, being a parent, and caregiving tasks and responsibilities. The investigators expect that the knowledge gained will increase clinicians' ability to respond to parents' needs.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Parenting After Infant Congenital Heart Defect Diagnosis

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Creation of a typology of perinatal internal working models of parenting in congenital heart disease. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Qualitative analysis of interviews.


Secondary Outcome Measures:
  • Parent outcomes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Impact of Event Scale - Stress Reactions Center for Epidemiologic Studies Depression Scale - Depression State-Trait Anxiety Inventory - Anxiety


Estimated Enrollment: 16
Study Start Date: September 2008
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prenatal/Postpartum CHD Diagnosis
parent of a baby (prenatal or postpartum)who was recently found to have a heart defect.

  Eligibility

Ages Eligible for Study:   up to 4 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

In this year-long study, 12 to 16 families (mothers and fathers) will be recruited—6 to 8 of the families from the fetal diagnosis clinic at either Meriter Hospital or Children's Hospital of Wisconsin and 6 to 8 families whose infant is diagnosed soon after birth with a complex CHD at either Meriter Hospital or Children's Hospital of Wisconsin.

Criteria

Inclusion Criteria for Parents:

  • at least 18 years old
  • English speaking and reading
  • not known to have a mental illness or cognitive deficit

Inclusion Criteria for Infant:

  • prenatal or postnatal diagnosis of a complex CHD that requires surgical repair or palliation early in the infant's life (i.e., tetralogy of Fallot, atrial-ventricular canal, ventricular septal defect, pulmonary stenosis, tricuspid atresia, hypoplastic right or left heart, or other complex condition). Infants will not be excluded if they also have congenital syndromes or extra-cardiac defects.

Exclusion Criteria:

  • no CHD diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503307

Locations
United States, Wisconsin
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
University of Wisconsin, Madison
Investigators
Principal Investigator: Karen Pridham, PhD, RN University of Wisconsin, Madison
Principal Investigator: Anne C McKechnie, PhDc,MS, RN, IBCLC University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Karen Pridham, Professor Emerita, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01503307     History of Changes
Other Study ID Numbers: CHW 08/160, GC 728
Study First Received: December 28, 2011
Last Updated: January 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
prenatal chd diagnosis
postpartum chd diagnosis
parenting
internal working models

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014