ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CTOTC-11
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02892266
Recruitment Status : Active, not recruiting
First Posted : September 8, 2016
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation in Children
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.


Condition or disease Intervention/treatment
Solid Organ Transplant Recipients Parent(s)/Guardian of Referenced Transplant Recipients Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Prevalence and Correlates of Post-Traumatic Stress Symptoms (PTSS) in Adolescent Solid Organ Transplant Recipients (CTOTC-11)
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
Adolescent Transplant Recipients
  1. Questionnaire battery at enrollment (Participants and their parents/guardians)
  2. 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



Primary Outcome Measures :
  1. Medication Level Variability Index (MLVI) [ Time Frame: 6 months retrospective data to 6 months post enrollment ]
    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.

  2. University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 (UCLA PTSD RI DSM-5) Total Score [ Time Frame: At enrollment visit ]
    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.


Secondary Outcome Measures :
  1. Above-threshold Medication Level Variability Index (MLVI) [ Time Frame: 6 months post enrollment ]
    Defined by an MLVI greater than 2.

  2. Above-threshold Child PTSS Score [ Time Frame: At enrollment visit ]
    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.

  3. Child Avoidance Score [ Time Frame: At enrollment visit ]
    Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score.

  4. Parent PTSS Total Score [ Time Frame: At enrollment visit ]
    Measured using the Impact of Event Scale (IES) self-report questionnaire.

  5. Parent Avoidance [ Time Frame: At enrollment visit ]
    Measured using IES self-report questionnaire subscore.

  6. Diagnosis of chronic allograft rejection [ Time Frame: 6 months retrospective data to 6 months post enrollment ]
  7. Diagnosis of graft failure [ Time Frame: 6 months retrospective data to 6 months post enrollment ]
  8. Child Depression/Distress Assessment [ Time Frame: At enrollment visit ]
    Depression/distress measured using the Children's Depression Inventory - Short Form (CDI-S) self-report questionnaire.

  9. Quality of Life (QOL) Assessment Using the PedsQL Total Score [ Time Frame: At enrollment visit ]
    Measured using the child self-report Pediatric Quality of Life (PedsQL) version 4.0.

  10. QOL Assessment Using PedsQL Subscale Scores [ Time Frame: At enrollment visit ]
    Measured using the child self-report PedsQL version 4.0 subscale scores.

  11. QOL Assessment Using the HRQOL (PedsQL) Total Score [ Time Frame: At enrollment visit ]
    Measured using the child self-report Transplant-Specific Health-Related Quality of Life (HRQOL) scale (PedsQL) version 4.0 summary score.

  12. PedsQL Family Impact Total Score [ Time Frame: At enrollment visit ]
    Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 summary score.

  13. PedsQL Family Impact Subscale Scores [ Time Frame: At enrollment visit ]
    Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 subscale scores.

  14. Types of traumas identified as salient by the child [ Time Frame: At enrollment visit ]
    Measured using the University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5).

  15. Types of traumas identified as salient by the parent [ Time Frame: At enrollment visit ]
    Measured using the parent/guardian Impact of Event Scale (IES).


Other Outcome Measures:
  1. Exploratory Outcome: Dose of steroids [ Time Frame: At enrollment ]
    Potential impact of steroid use on PTSD will be assessed by a correlation coefficient between mean steroid dose per kilogram.

  2. Exploratory Outcome: Presence of Donor Specific Antibodies (DSA) [ Time Frame: At enrollment Visit ]

Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adolescent transplant recipients at risk for non-adherence and can reliably answer self-report questionnaires.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892266


Locations
United States, California
Ronald Reagan UCLA Medical Center: Pediatric Transplantation
Los Angeles, California, United States, 90095
Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation
Palo Alto, California, United States, 94304
UCSF Benioff Children's Hospital: Pediatric Transplantation
San Francisco, California, United States, 94143
United States, Florida
University of Miami, Jackson Memorial Hospital: Pediatric Transplantation
Miami, Florida, United States, 33136
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation
Chicago, Illinois, United States, 60611
United States, Massachusetts
Boston Children's Hospital: Pediatric Transplantation
Boston, Massachusetts, United States, 02215
United States, Missouri
St. Louis Children's Hospital: Pediatric Transplantation
Saint Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center: Pediatric Transplantation
New York, New York, United States, 10032
United States, Ohio
Cincinnati Children's Hospital Medical Center: Pediatric Transplantation
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Philadelphia: Pediatric Transplantation
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation
Dallas, Texas, United States, 75235
Texas Children's Hospital: Pediatric Transplantation
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation in Children
Investigators
Study Chair: Stuart Sweet, M.D., Ph.D. St. Louis Children's Hospital: Pediatric Transplantation

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02892266     History of Changes
Other Study ID Numbers: DAIT CTOTC-11
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Transplant recipients
Adolescents
Post-Traumatic Stress Symptoms (PTSS)
Transplant Recipient and Family Impact(s)