Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients

Completed

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

In brief

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.

Key facts

Study ID

NCT02892266

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

124

Starts

2016-09-01

Expected to finish

2018-11-24

Last updated by the study team

2019-01-07

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• UCSF Benioff Children's Hospital: Pediatric Transplantation — San Francisco, California, United States
• University of Miami, Jackson Memorial Hospital: Pediatric Transplantation — Miami, Florida, United States
• Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation — Chicago, Illinois, United States
• Boston Children's Hospital: Pediatric Transplantation — Boston, Massachusetts, United States
• St. Louis Children's Hospital: Pediatric Transplantation — St Louis, Missouri, United States
• Columbia University Medical Center: Pediatric Transplantation — New York, New York, United States
• Cincinnati Children's Hospital Medical Center: Pediatric Transplantation — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia: Pediatric Transplantation — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation — Dallas, Texas, United States
• Texas Children's Hospital: Pediatric Transplantation — Houston, Texas, United States

Full record on ClinicalTrials.gov

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