The PaTHS Descriptive Correlational Longitudinal Study

Posttraumatic Stress Disorder Clinical Trial

— PaTHS  

Official title:

Parents Post-traumatic Stress Before and After Their Infant's Second Palliative Heart Surgery: The PaTHS Descriptive Correlational Longitudinal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785482
• Other study ID #: STUDY00001652
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: June 9, 2022

Study information

• Verified date: July 2022
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to measure parent's post-traumatic stress before and after their infant's second palliative heart surgery for single ventricle congenital heart disease. The investigators will use the posttraumatic stress disorder checklist for the DSM-V (PCL-5) to measure levels 2-4 weeks before and after the infant's second heart surgery. The investigators aim to describe the levels at the two-time points, compare the scores, and identify demographic information that correlates with the scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parent who is 18 years or older of an infant with SVCHD
• Following with CHAMP through Children's Mercy Hospital. Any person personally identifying as a parent of the child, who lives in the same household as the infant, and who will provide primary care after discharge from the hospital is eligible to participate.

Exclusion Criteria:

• Parents of an SVCHD infant who is undergoing end-of-life care, determined by the primary care team.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Psychosocial Impairment
• Single-ventricle
• Stress Disorders, Post-Traumatic
• Univentricular Heart

Locations

Country	Name	City	State
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Examine the relationship of parental post-traumatic stress level before and after their infant's second palliative heart surgery.	Compare the two PCL-5 scores.	through study completion, an average of 1 year
Other	Examine what demographic variables are the mediators and moderators of the correlations.	Examine any correlation between selected demographics and PCL-5 scores.	through study completion, an average of 1 year
Primary	Measure the level of parental post-traumatic stress two to four weeks before their infant's second palliative heart surgery	Measure level using the posttraumatic stress disorder checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. The scores range 0-80 with scores greater than or equal to 31 suggest provisional Posttraumatic stress disorder diagnosis.	on average at 4-6 months of age
Secondary	Measure the level of parental post-traumatic stress two to four weeks after discharge following their infant's second palliative heart surgery.	Measure level using the posttraumatic stress disorder checklist for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. The scores range 0-80 with scores greater than or equal to 31 suggest provisional Posttraumatic stress disorder diagnosis.	On average 5-6 months of age