Clinical trial NCT02892266: Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients
Official title: Prevalence and Correlates of Post-Traumatic Stress Symptoms (PTSS) in Adolescent Solid Organ Transplant Recipients (CTOTC-11)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Organ Transplant Recipients
Parent(s)/Guardian of Referenced Transplant Recipients
Keywords: Transplant recipients
Adolescents
Post-Traumatic Stress Symptoms (PTSS)
Transplant Recipient and Family Impact(s)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Clinical Trials in Organ Transplantation in Children
First posted: 2016-09-08
Enrollment: 124
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent transplant recipients at risk for non-adherence and can reliably answer self-report questionnaires.

Brief 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 criteria: 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.

Primary outcomes:
measure: Medication Level Variability Index (MLVI)
timeFrame: 6 months retrospective data to 6 months post enrollment
measure: University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 (UCLA PTSD RI DSM-5) Total Score
timeFrame: At enrollment visit
Secondary outcomes:
measure: Above-threshold Medication Level Variability Index (MLVI)
timeFrame: 6 months post enrollment
measure: Above-threshold Child PTSS Score
timeFrame: At enrollment visit
measure: Child Avoidance Score
timeFrame: At enrollment visit
measure: Parent PTSS Total Score
timeFrame: At enrollment visit
measure: Parent Avoidance
timeFrame: At enrollment visit
measure: Diagnosis of chronic allograft rejection
timeFrame: 6 months retrospective data to 6 months post enrollment
measure: Diagnosis of graft failure
timeFrame: 6 months retrospective data to 6 months post enrollment
measure: Child Depression/Distress Assessment
timeFrame: At enrollment visit
measure: Quality of Life (QOL) Assessment Using the PedsQL Total Score
timeFrame: At enrollment visit
measure: QOL Assessment Using PedsQL Subscale Scores
timeFrame: At enrollment visit
measure: QOL Assessment Using the HRQOL (PedsQL) Total Score
timeFrame: At enrollment visit
measure: PedsQL Family Impact Total Score
timeFrame: At enrollment visit
measure: PedsQL Family Impact Subscale Scores
timeFrame: At enrollment visit
measure: Types of traumas identified as salient by the child
timeFrame: At enrollment visit
measure: Types of traumas identified as salient by the parent
timeFrame: At enrollment visit
Other outcomes:
measure: Exploratory Outcome: Dose of steroids
timeFrame: At enrollment
measure: Exploratory Outcome: Presence of Donor Specific Antibodies (DSA)
timeFrame: At enrollment Visit
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center: Pediatric Transplantation
state: California
city: Palo Alto
country: United States
facility: Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital: Pediatric Transplantation
state: California
city: Miami
country: United States
facility: University of Miami, Jackson Memorial Hospital: Pediatric Transplantation
state: Florida
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation
state: Illinois
city: Boston
country: United States
facility: Boston Children's Hospital: Pediatric Transplantation
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital: Pediatric Transplantation
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center: Pediatric Transplantation
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center: Pediatric Transplantation
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia: Pediatric Transplantation
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital: Pediatric Transplantation
state: Texas
Study officials:
affiliation: St. Louis Children's Hospital: Pediatric Transplantation
name: Stuart Sweet, M.D., Ph.D.
role: STUDY_CHAIR
References: