Post‐Traumatic Stress Symptoms (PTSS) in Transplant Recipients

Solid Organ Transplant Recipients Clinical Trial

— CTOTC-11  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892266
• Other study ID #: DAIT CTOTC-11
• Status: Completed
• Start date: September 2016
• Est. completion date: November 24, 2018

Study information

• Verified date: January 2019
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: November 24, 2018
• Est. primary completion date: November 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parent(s)/Guardian of Referenced Transplant Recipients
• Solid Organ Transplant Recipients

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital: Pediatric Transplantation	Boston	Massachusetts
United States	Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center: Pediatric Transplantation	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation	Dallas	Texas
United States	Texas Children's Hospital: Pediatric Transplantation	Houston	Texas
United States	Ronald Reagan UCLA Medical Center: Pediatric Transplantation	Los Angeles	California
United States	University of Miami, Jackson Memorial Hospital: Pediatric Transplantation	Miami	Florida
United States	Columbia University Medical Center: Pediatric Transplantation	New York	New York
United States	Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation	Palo Alto	California
United States	Children's Hospital of Philadelphia: Pediatric Transplantation	Philadelphia	Pennsylvania
United States	St. Louis Children's Hospital: Pediatric Transplantation	Saint Louis	Missouri
United States	UCSF Benioff Children's Hospital: Pediatric Transplantation	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Clinical Trials in Organ Transplantation in Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Exploratory Outcome: Presence of Donor Specific Antibodies (DSA)		At enrollment Visit
Primary	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
Primary	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	Above-threshold Medication Level Variability Index (MLVI)	Defined by an MLVI greater than 2.	6 months post enrollment
Secondary	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
Secondary	Child Avoidance Score	Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score.	At enrollment visit
Secondary	Parent PTSS Total Score	Measured using the Impact of Event Scale (IES) self-report questionnaire.	At enrollment visit
Secondary	Parent Avoidance	Measured using IES self-report questionnaire subscore.	At enrollment visit
Secondary	Diagnosis of chronic allograft rejection		6 months retrospective data to 6 months post enrollment
Secondary	Diagnosis of graft failure		6 months retrospective data to 6 months post enrollment
Secondary	Child Depression/Distress Assessment	Depression/distress measured using the Children's Depression Inventory - Short Form (CDI-S) self-report questionnaire.	At enrollment visit
Secondary	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
Secondary	QOL Assessment Using PedsQL Subscale Scores	Measured using the child self-report PedsQL version 4.0 subscale scores.	At enrollment visit
Secondary	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
Secondary	PedsQL Family Impact Total Score	Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 summary score.	At enrollment visit
Secondary	PedsQL Family Impact Subscale Scores	Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 subscale scores.	At enrollment visit
Secondary	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
Secondary	Types of traumas identified as salient by the parent	Measured using the parent/guardian Impact of Event Scale (IES).	At enrollment visit

External Links

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