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Completed

NCT Number: NCT04785482

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.

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Key information

Conditions

Single-ventricle Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Mental Disorders Posttraumatic Stress Disorder Psychosocial Impairment Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Univentricular Heart

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Measure the level of parental post-traumatic stress two to four weeks before their infant's second palliative heart surgery

    Time frame: 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 outcomes

  1. Measure the level of parental post-traumatic stress two to four weeks after discharge following their infant's second palliative heart surgery.

    Time frame: 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.

Other outcomes

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

    Time frame: through study completion, an average of 1 year

    Compare the two PCL-5 scores.

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

    Time frame: through study completion, an average of 1 year

    Examine any correlation between selected demographics and PCL-5 scores.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • University of Missouri, Kansas City

Registry information

Official study title

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

Acronym: PaTHS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2021
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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