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The PaTHS Descriptive Correlational Longitudinal Study (PaTHS)

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ClinicalTrials.gov Identifier: NCT04785482
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : March 8, 2021
Sponsor:
Collaborator:
University of Missouri, Kansas City
Information provided by (Responsible Party):
Melissa, Children's Mercy Hospital Kansas City

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
Single-ventricle Posttraumatic Stress Disorder Psychosocial Impairment

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Study Type : Observational
Estimated Enrollment : 52 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 : March 1, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : May 2022


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



Primary Outcome Measures :
  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 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. [ 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 Outcome Measures:
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04785482


Contacts
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Contact: Melissa Elliott 816-915-5083 mdelliott@cmh.edu

Locations
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United States, Missouri
Children's Mercy Hospitals and Clinics Recruiting
Kansas City, Missouri, United States, 64108
Contact: Melissa Elliott    931-626-6873    melliott.fnp@gmail.com   
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of Missouri, Kansas City
Investigators
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Principal Investigator: Melissa Elliott Advanced Practice Registered Nurse
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Responsible Party: Melissa, Advanced Practice Registered Nurse, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT04785482    
Other Study ID Numbers: STUDY00001652
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melissa, Children's Mercy Hospital Kansas City:
remote monitoring
nursing
parents
transition
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders