Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients
- Conditions
- Solid Organ Transplant RecipientsParent(s)/Guardian of Referenced Transplant Recipients
- Registration Number
- NCT02892266
- Brief Summary
This study is conducted to better understand Post-Traumatic Stress Symptoms (PTSS) in adolescent transplant recipients and their parent/guardian and to see if PTSS play a role in the way adolescent transplant recipients take their prescribed medicine.
Target population: medically stable adolescent solid organ (e.g., heart, kidney, liver, lung, small bowel) transplant recipients and their parent(s)/guardian.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
The patient:
- and/or their parent(s)/guardian must be able to understand and provide informed consent in English or Spanish;
- is prescribed tacrolimus (either brand or generic formulation); and
- has been seen in the enrolling center's clinic at least twice in the last two years.
The patient:
- received a transplant less than 18 months prior to enrollment;
- has had more than one transplant (including marrow replacement);
- or their parent(s)/guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion);
- or their parent(s)/guardian has been diagnosed with severe intellectual disability as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5);
- is not medically stable or is hospitalized;
- is currently enrolled in a study that aims to improve adherence to medical recommendations;
- is receiving cognitive behavioral therapy for confirmed or suspected diagnosis of Post-Traumatic Stress Disorder (PTSD) at enrollment;
- is receiving psychotropic medications for a confirmed or suspected diagnosis of PTSD.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Medication Level Variability Index (MLVI) 6 months retrospective data to 6 months post enrollment Defined by fluctuation in medication blood levels. Calculated as the standard deviation (variation) of a minimum of 3 outpatient tacrolimus trough levels, obtained for one year, consisting of 6 months prior to study enrollment plus 6 months post study enrollment.
University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 (UCLA PTSD RI DSM-5) Total Score At enrollment visit The UCLA PTSD RI DSM-5 is a widely used and validated self-report questionnaire assessing posttraumatic stress symptoms (PTSS) in children and adolescents ages 8-18 years.
- Secondary Outcome Measures
Name Time Method Child Depression/Distress Assessment At enrollment visit Depression/distress measured using the Children's Depression Inventory - Short Form (CDI-S) self-report questionnaire.
Above-threshold Medication Level Variability Index (MLVI) 6 months post enrollment Defined by an MLVI greater than 2.
Diagnosis of chronic allograft rejection 6 months retrospective data to 6 months post enrollment QOL Assessment Using PedsQL Subscale Scores At enrollment visit Measured using the child self-report PedsQL version 4.0 subscale scores.
Above-threshold Child PTSS Score At enrollment visit Defined as the existence of threshold scores in a symptoms constellation corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition of Post-Traumatic Stress Disorder (PTSD). Method: University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5) self-report questionnaire.
Child Avoidance Score At enrollment visit Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score.
Diagnosis of graft failure 6 months retrospective data to 6 months post enrollment Parent PTSS Total Score At enrollment visit Measured using the Impact of Event Scale (IES) self-report questionnaire.
QOL Assessment Using the HRQOL (PedsQL) Total Score At enrollment visit Measured using the child self-report Transplant-Specific Health-Related Quality of Life (HRQOL) scale (PedsQL) version 4.0 summary score.
Parent Avoidance At enrollment visit Measured using IES self-report questionnaire subscore.
Quality of Life (QOL) Assessment Using the PedsQL Total Score At enrollment visit Measured using the child self-report Pediatric Quality of Life (PedsQL) version 4.0.
PedsQL Family Impact Total Score At enrollment visit Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 summary score.
PedsQL Family Impact Subscale Scores At enrollment visit Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 subscale scores.
Types of traumas identified as salient by the parent At enrollment visit Measured using the parent/guardian Impact of Event Scale (IES).
Types of traumas identified as salient by the child At enrollment visit Measured using the University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5).
Trial Locations
- Locations (13)
Ronald Reagan UCLA Medical Center: Pediatric Transplantation
🇺🇸Los Angeles, California, United States
Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation
🇺🇸Palo Alto, California, United States
UCSF Benioff Children's Hospital: Pediatric Transplantation
🇺🇸San Francisco, California, United States
University of Miami, Jackson Memorial Hospital: Pediatric Transplantation
🇺🇸Miami, Florida, United States
Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation
🇺🇸Chicago, Illinois, United States
Boston Children's Hospital: Pediatric Transplantation
🇺🇸Boston, Massachusetts, United States
St. Louis Children's Hospital: Pediatric Transplantation
🇺🇸Saint Louis, Missouri, United States
Columbia University Medical Center: Pediatric Transplantation
🇺🇸New York, New York, United States
Cincinnati Children's Hospital Medical Center: Pediatric Transplantation
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Scroll for more (3 remaining)Ronald Reagan UCLA Medical Center: Pediatric Transplantation🇺🇸Los Angeles, California, United States