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Eligibility
for people ages 12 years to 17 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Official Title

Prevalence and Correlates of Post-Traumatic Stress Symptoms (PTSS) in Adolescent Solid Organ Transplant Recipients (CTOTC-11)

Keywords

Solid Organ Transplant Recipients Parent(s)/Guardian of Referenced Transplant Recipients Transplant recipients Adolescents Post-Traumatic Stress Symptoms (PTSS) Transplant Recipient and Family Impact(s)

Eligibility

You can join if…

Open to people ages 12 years to 17 years

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 CAN'T join 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.

Locations

  • Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation not yet accepting patients
    Palo Alto, California, 94304, USA
  • Ronald Reagan UCLA Medical Center: Pediatric Transplantation not yet accepting patients
    Los Angeles, California, 90095, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
The Clinical Trials in Organ Transplantation in Children (CTOT-C)
ID
NCT02892266
Lead Scientist
Emily Perito
Study Type
Observational
Last Updated
September 2016
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