Prevalence and Correlates of Post-Traumatic Stress Symptoms (PTSS) in Adolescent Solid Organ Transplant Recipients (CTOTC-11)
Status: Completed
Location: See all (13) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: No
View:
• 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.
Locations
United States
California
Ronald Reagan UCLA Medical Center: Pediatric Transplantation
Los Angeles
Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation
Palo Alto
UCSF Benioff Children's Hospital: Pediatric Transplantation
San Francisco
Florida
University of Miami, Jackson Memorial Hospital: Pediatric Transplantation
Miami
Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation
Chicago
Massachusetts
Boston Children's Hospital: Pediatric Transplantation
Boston
Missouri
St. Louis Children's Hospital: Pediatric Transplantation
Saint Louis
New York
Columbia University Medical Center: Pediatric Transplantation
New York
Ohio
Cincinnati Children's Hospital Medical Center: Pediatric Transplantation
Cincinnati
Nationwide Children's Hospital
Columbus
Pennsylvania
Children's Hospital of Philadelphia: Pediatric Transplantation
Philadelphia
Texas
University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation
Dallas
Texas Children's Hospital: Pediatric Transplantation
Houston
Time Frame
Start Date: September 2016
Completion Date: November 24, 2018
Participants
Target number of participants: 124
Treatments
Adolescent Transplant Recipients
Questionnaire battery at enrollment (Participants and their parents/guardians)~Clinical data from patient's chart (6 months of retrospective data & 6 months of prospective tacrolimus trough level data)
Authors
Dev Desai, Robert Venick, Emily Perito, Carlos Esquivel, Samuel Goldfarb, Stuart Sweet, Estella Alonso, Nada Yazigi, Linda Addonizio, Don Hayes, Gary Visner, Akin Tekin, Thomas Fishbein, Ernestina Melicoff‐Portillo, Lara Danziger‐Isakov
Sponsors
Collaborators: Clinical Trials in Organ Transplantation in Children
Leads: National Institute of Allergy and Infectious Diseases (NIAID)