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)
Sponsors
Collaborators: Clinical Trials in Organ Transplantation in Children
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov

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