Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients

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Trial ID: NCT02892266

Purpose

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

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

Stanford Investigator(s)

Carlos O. Esquivel, M.D., Ph.D.,FACS
Carlos O. Esquivel, M.D., Ph.D.,FACS

Arnold and Barbara Silverman Professor in Pediatric Transplantation and Professor of Surgery (Abdominal Transplantation) and of Pediatrics (Gastroenterology, Hepatology and Nutrition)

Eligibility


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.

Intervention(s):

other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Gioia Zucchero
6504985689