The PaTHS Descriptive Correlational Longitudinal Study

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT04785482
Collaborator
University of Missouri, Kansas City (Other)
22
1
15.3
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    22 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Parents Post-traumatic Stress Before and After Their Infant's Second Palliative Heart Surgery: The PaTHS Descriptive Correlational Longitudinal Study
    Actual Study Start Date :
    Mar 1, 2021
    Actual Primary Completion Date :
    Jun 9, 2022
    Actual Study Completion Date :
    Jun 9, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Parents of infants with single ventricle heart disease

    All participants

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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]

      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 Outcome Measures

    1. 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]

      Compare the two PCL-5 scores.

    2. Examine what demographic variables are the mediators and moderators of the correlations. [through study completion, an average of 1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Melissa Elliott, Advanced Practice Registered Nurse

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melissa Elliott, Advanced Practice Registered Nurse, Children's Mercy Hospital Kansas City
    ClinicalTrials.gov Identifier:
    NCT04785482
    Other Study ID Numbers:
    • STUDY00001652
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Melissa Elliott, Advanced Practice Registered Nurse, Children's Mercy Hospital Kansas City
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 22, 2022