Family Adaptation Study Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn

Hypoplastic Left Heart Syndrome Clinical Trial

Official title:

Family Stress, Coping and Outcomes Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734643
• Other study ID #: CHW 06/117
• Status: Completed
• Start date: June 2006
• Est. completion date: September 5, 2019

Study information

• Verified date: January 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Survival for one of the most complex forms of congenital heart disease, hypoplastic left heart syndrome (HLHS), has improved dramatically. However, little is known about family stress, coping and outcomes following the diagnosis of HLHS. It is expected that families face emotional, social and financial stressors. Health care professionals have a unique opportunity to positively influence how families interpret and adapt to these stressors. The specific aims of the study are to describe perceived stress, and coping skills utilized, in parents of children with HLHS and their impact on family outcomes measured as well-being, adaptation and caregiver/family quality of life, and to describe changes in stress, coping, and adaptation and differences in perceptions of mothers versus fathers of children with HLHS over the first 14 months of life. The Resiliency Model of Family Adjustment and Adaptation (McCubbin, Thompson, & McCubbin, 1996) is the theoretical framework that guides this research.

Hypotheses:

1. Family perception of stress, and coping skills utilized, will have an impact on family outcomes measured as well-being, adaptation, and caregiver/family quality of life.

2. Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes.

3. Perceptions of stress, coping skills utilized, and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS.

4. Mothers and fathers will report different perceptions of stress, coping skills utilized, and family adaptation outcomes during the first 14 months of life with an infant with HLHS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: September 5, 2019
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• Parents of all patients diagnosed with complex congenital heart disease requiring hospitalization or intervention during the neonatal period

Exclusion Criteria:

• Parents unable to speak or read English

Related Conditions & MeSH terms

• Hypoplastic Left Heart Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (11)

Lead Sponsor	Collaborator
Medical College of Wisconsin	American Nurses Foundation, Arkansas Children's Hospital Research Institute, Boston Children’s Hospital, Children's Hospital and Health System Foundation, Wisconsin, Children's Hospital of Philadelphia, Columbia University, Johns Hopkins All Children's Hospital, Medical University of South Carolina, Nicklaus Children's Hospital f/k/a Miami Children's Hospital, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Family Adaptation	Family adaptation will be measured with the general functioning scale of the Family Assessment Device (FAD) (Miller, Epstein, Bishop & Keitner, 1985) at T1, T2 and T3. The FAD provides an overall measure of family functioning; 12 items, reliability alpha = .83-.86.	14 months