Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients

Trial ID or NCT#

NCT02892266

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: 12 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. The patient:
    1. * 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:
  1. The patient:
    1. * 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.
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Investigator(s)

Carlos O. Esquivel, M.D., Ph.D.,FACS
Carlos O. Esquivel, M.D., Ph.D.,FACS
Transplant surgeon, Liver transplant surgeon, Kidney transplant surgeon, Hepatobiliary surgeon, Pancreatic surgeon, Pancreas transplant surgeon
Arnold and Barbara Silverman Professor in Pediatric Transplantation and Professor of Surgery (Abdominal Transplantation) and of Pediatrics (Gastroenterology, Hepatology and Nutrition)

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Contact

Gioia Zucchero
6504985689

View on ClinicalTrials.gov