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

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

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.

Study Overview

• Status: Completed
• Conditions: Solid Organ Transplant Recipients; Parent(s)/Guardian of Referenced Transplant Recipients
• Intervention / Treatment: Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Ronald Reagan UCLA Medical Center: Pediatric Transplantation
    • Palo Alto, California, United States, 94304
      • Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation
    • San Francisco, California, United States, 94143
      • UCSF Benioff Children's Hospital: Pediatric Transplantation
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami, Jackson Memorial Hospital: Pediatric Transplantation
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston Children's Hospital: Pediatric Transplantation
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital: Pediatric Transplantation
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center: Pediatric Transplantation
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center: Pediatric Transplantation
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia: Pediatric Transplantation
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital: Pediatric Transplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adolescent transplant recipients at risk for non-adherence and can reliably answer self-report questionnaires.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Level Variability Index (MLVI)	Defined by fluctuation in medication blood levels. Calculated as the standard deviation (variation) of a minimum of 3 outpatient tacrolimus trough levels, obtained for one year, consisting of 6 months prior to study enrollment plus 6 months post study enrollment.	6 months retrospective data to 6 months post enrollment
University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 (UCLA PTSD RI DSM-5) Total Score	The UCLA PTSD RI DSM-5 is a widely used and validated self-report questionnaire assessing posttraumatic stress symptoms (PTSS) in children and adolescents ages 8-18 years.	At enrollment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Above-threshold Medication Level Variability Index (MLVI)	Defined by an MLVI greater than 2.	6 months post enrollment
Above-threshold Child PTSS Score	Defined as the existence of threshold scores in a symptoms constellation corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition of Post-Traumatic Stress Disorder (PTSD). Method: University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5) self-report questionnaire.	At enrollment visit
Child Avoidance Score	Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score.	At enrollment visit
Parent PTSS Total Score	Measured using the Impact of Event Scale (IES) self-report questionnaire.	At enrollment visit
Parent Avoidance	Measured using IES self-report questionnaire subscore.	At enrollment visit
Diagnosis of chronic allograft rejection		6 months retrospective data to 6 months post enrollment
Diagnosis of graft failure		6 months retrospective data to 6 months post enrollment
Child Depression/Distress Assessment	Depression/distress measured using the Children's Depression Inventory - Short Form (CDI-S) self-report questionnaire.	At enrollment visit
Quality of Life (QOL) Assessment Using the PedsQL Total Score	Measured using the child self-report Pediatric Quality of Life (PedsQL) version 4.0.	At enrollment visit
QOL Assessment Using PedsQL Subscale Scores	Measured using the child self-report PedsQL version 4.0 subscale scores.	At enrollment visit
QOL Assessment Using the HRQOL (PedsQL) Total Score	Measured using the child self-report Transplant-Specific Health-Related Quality of Life (HRQOL) scale (PedsQL) version 4.0 summary score.	At enrollment visit
PedsQL Family Impact Total Score	Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 summary score.	At enrollment visit
PedsQL Family Impact Subscale Scores	Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 subscale scores.	At enrollment visit
Types of traumas identified as salient by the child	Measured using the University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5).	At enrollment visit
Types of traumas identified as salient by the parent	Measured using the parent/guardian Impact of Event Scale (IES).	At enrollment visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Outcome: Dose of steroids	Potential impact of steroid use on PTSD will be assessed by a correlation coefficient between mean steroid dose per kilogram.	At enrollment
Exploratory Outcome: Presence of Donor Specific Antibodies (DSA)		At enrollment Visit

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Clinical Trials in Organ Transplantation in Children
• Investigators: Study Chair: Stuart Sweet, M.D., Ph.D., St. Louis Children's Hospital: Pediatric Transplantation

Publications and helpful links

Helpful Links

• Division of Allergy, Immunology, and Transplantation (DAIT)
• The National Institute of Allergy and Infectious Diseases (NIAID)
• The Clinical Trials in Organ Transplantation in Children (CTOT-C)

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): November 24, 2018
• Study Completion (Actual): November 24, 2018

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 8, 2016

Study Record Updates

• Last Update Posted (Actual): January 7, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Adolescents; Transplant recipients; Post-Traumatic Stress Symptoms (PTSS); Transplant Recipient and Family Impact(s)
• Other Study ID Numbers: DAIT CTOTC-11