Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients

National Institute of Allergy and Infectious Diseases (NIAID)124 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

124

Conditions

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

Interventions

Assessment of adherence, mental health, behavioral, quality of life and biological constructsOTHER

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: At enrollment visit

Secondary Outcomes

Above-threshold Medication Level Variability Index (MLVI)

Defined by an MLVI greater than 2.

Time frame: 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.

Time frame: At enrollment visit

Child Avoidance Score

Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score.

Time frame: At enrollment visit

Parent PTSS Total Score

Measured using the Impact of Event Scale (IES) self-report questionnaire.

Data from ClinicalTrials.gov

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