Parenting After Infant Congenital Heart Defect Diagnosis
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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 |
- 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.
- 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 |
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.
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| United States, Wisconsin | |
| University of Wisconsin Madison | |
| Madison, Wisconsin, United States, 53792 | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| 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 May 19, 2013