Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients

Study Overview
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Brief Summary
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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.

Official Title
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Prevalence and Correlates of Post-Traumatic Stress Symptoms (PTSS) in Adolescent Solid Organ Transplant Recipients (CTOTC-11)

Conditions
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Solid Organ Transplant Recipients, Parent(s)/Guardian of Referenced Transplant Recipients

Intervention / Treatment
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* Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescent Transplant Recipients<br>Questionnaire battery at enrollment (Participants and their parents/guardians) Clinical data from patient's chart (6 months of retrospective data & 6 months of prospective tacrolimus trough level data) | Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Level Variability Index (MLVI) | 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. | 6 months retrospective data to 6 months post enrollment | 
| University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 (UCLA PTSD RI DSM-5) Total Score | 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. | At enrollment visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Above-threshold Medication Level Variability Index (MLVI) | Defined by an MLVI greater than 2. | 6 months post enrollment | 
| Above-threshold Child PTSS Score | 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. | At enrollment visit | 
| Child Avoidance Score | Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score. | At enrollment visit | 
| Parent PTSS Total Score | Measured using the Impact of Event Scale (IES) self-report questionnaire. | At enrollment visit | 
| Parent Avoidance | Measured using IES self-report questionnaire subscore. | At enrollment visit | 
| Diagnosis of chronic allograft rejection |  | 6 months retrospective data to 6 months post enrollment | 
| Diagnosis of graft failure |  | 6 months retrospective data to 6 months post enrollment | 
| Child Depression/Distress Assessment | Depression/distress measured using the Children's Depression Inventory - Short Form (CDI-S) self-report questionnaire. | At enrollment visit | 
| Quality of Life (QOL) Assessment Using the PedsQL Total Score | Measured using the child self-report Pediatric Quality of Life (PedsQL) version 4.0. | At enrollment visit | 
| QOL Assessment Using PedsQL Subscale Scores | Measured using the child self-report PedsQL version 4.0 subscale scores. | At enrollment visit | 
| QOL Assessment Using the HRQOL (PedsQL) Total Score | Measured using the child self-report Transplant-Specific Health-Related Quality of Life (HRQOL) scale (PedsQL) version 4.0 summary score. | At enrollment visit | 
| PedsQL Family Impact Total Score | Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 summary score. | At enrollment visit | 
| PedsQL Family Impact Subscale Scores | Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 subscale scores. | At enrollment visit | 
| Types of traumas identified as salient by the child | Measured using the University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5). | At enrollment visit | 
| Types of traumas identified as salient by the parent | Measured using the parent/guardian Impact of Event Scale (IES). | At enrollment visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplant recipients, Adolescents, Post-Traumatic Stress Symptoms (PTSS), Transplant Recipient and Family Impact(s)