Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients
Trial ID or NCT#
Status
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
- 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.
Investigator(s)
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Contact
Gioia Zucchero
6504985689
View on ClinicalTrials.gov