The PaTHS Descriptive Correlational Longitudinal Study

NCT04785482 | Completed

• 1 other identifier: STUDY00001652
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Single-ventricle; Posttraumatic Stress Disorder; Psychosocial Impairment

Keywords

remote monitoring; nursing; parents; transition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (2)

• Examine the relationship of parental post-traumatic stress level before and after their infant's second palliative heart surgery.

  through study completion, an average of 1 year

• Examine what demographic variables are the mediators and moderators of the correlations.

  through study completion, an average of 1 year

Study Arms (1)

Parents of infants with single ventricle heart disease

All participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• University of Missouri, Kansas City: collaborator

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Univentricular Heart; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Melissa Elliott

  Advanced Practice Registered Nurse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Practice Registered Nurse

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: March 1, 2021
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)