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The PaTHS Descriptive Correlational Longitudinal Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04785482
Acronym
PaTHS
Enrollment
22
Registered
2021-03-08
Start date
2021-03-01
Completion date
2022-06-09
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder, Psychosocial Impairment, Single-ventricle

Keywords

remote monitoring, nursing, parents, transition

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.

Interventions

None listed

Sponsors

University of Missouri, Kansas City
CollaboratorOTHER
Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Measure the level of parental post-traumatic stress two to four weeks before their infant's second palliative heart surgeryon average at 4-6 months of ageMeasure 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

MeasureTime frameDescription
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 ageMeasure 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.

Other

MeasureTime frameDescription
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 yearCompare the two PCL-5 scores.
Examine what demographic variables are the mediators and moderators of the correlations.through study completion, an average of 1 yearExamine any correlation between selected demographics and PCL-5 scores.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026