Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients (CTOTC-11)

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

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

Treatments: Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02892266

DAIT CTOTC-11

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

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.

Trial design

124 participants in 1 patient group

Adolescent Transplant Recipients

Description:

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)

Treatment:

Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs