The PaTHS Descriptive Correlational Longitudinal Study

Completed

• Conditions: Posttraumatic Stress Disorder; Single-ventricle; Psychosocial Impairment

• Registration Number: NCT04785482
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-08
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure the level of parental post-traumatic stress two to four weeks before their infant's second palliative heart surgery	on average at 4-6 months of age	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.

Secondary Outcome Measures

Name	Time	Method
Measure the level of parental post-traumatic stress two to four weeks after discharge following their infant's second palliative heart surgery.	On average 5-6 months of age	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.

Trial Locations

Locations (1)

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States