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
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Anne Chevalier McKechnie, PhD, RN, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01503307
First received: December 28, 2011
Last updated: August 19, 2015
Last verified: August 2015
  Purpose

The purpose of this research study is to learn about parents' experiences following diagnosis of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other health-care clinicians will benefit from an improved understanding of what the diagnosis means to parents and what they expect concerning the infant, 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: January 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (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.

Detailed Description:

Parental mental health status is linked to the development and quality of caregiving, as well as physiological and psychosocial outcomes for the infant/child with a heart defect.

This is an evolving population of parents with most challenged prenatally with a fetal diagnosis and later as caregivers for medically complex infants. Parents with pre- and postnatally diagnosed infants are at risk for sub-optimal mental health. Parents' experiences and needs differ by timing of diagnosis.

Several gaps in the literature exist. First, advances in technology raise questions about how becoming a caregiver is experienced considering the timing of the diagnosis. Second, little is known about how the timing of the diagnosis could influence parents' mental health status and caregiving after diagnosis. Finally, more study is needed to identify the type, timing and duration of intervention to support these parents as caregivers and optimize their infants' health.

Data collected for this study included demographic and health information (from parents and infant health records), measures of distress (symptoms of depression, anxiety and trauma), and interviews. Semi-structured interviews were conducted with parents in person in the hospital and home settings. Interviews with each couple in the prenatally diagnosed group were conducted once during the third trimester of pregnancy and once within 12 weeks after birth. Interviews with each couple or mother in the postnatally diagnosed group were conducted once within 12 weeks after birth. Interviews lasted 1-3 hours, were audio-recorded and transcribed verbatim for analysis. Field notes were also written and audio recorded for use in analysis.

Directed content analysis has been used to describe parents' experiences and caregiving motivations in relation to parental distress and severity of infant illness. Analysis of data is ongoing. Additional analyses are expected to further improve knowledge on the differing needs of parents of pre- and postnatally diagnosed infants, as well as parents' experiences and caregiving motivations in the context of discharge from tertiary care.

  Eligibility

Ages Eligible for Study:   up to 12 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
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Karen Pridham, PhD, RN University of Wisconsin, Madison
Principal Investigator: Anne C McKechnie, PhD, RN University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Anne Chevalier McKechnie, PhD, RN, Research Scientist, 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: August 19, 2015
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
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases

ClinicalTrials.gov processed this record on September 01, 2015