The PaTHS Descriptive Correlational Longitudinal Study (PaTHS)

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Parents of infants with single ventricle congenital heart disease participating in the Cardiac High Acuity Monitoring Program (CHAMP)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Parents of infants with single ventricle heart disease; All participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Collaborators: University of Missouri, Kansas City
• Investigators: Principal Investigator: Melissa Elliott, Advanced Practice Registered Nurse

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): June 9, 2022
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: nursing; parents; transition; remote monitoring
• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Trauma and Stressor Related Disorders; Heart Defects, Congenital; Cardiovascular Abnormalities; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Univentricular Heart
• Other Study ID Numbers: STUDY00001652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No