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Trial record 1 of 1 for:    CTOTC-11
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Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients (CTOTC-11)

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ClinicalTrials.gov Identifier: NCT02892266
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation in Children
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date August 11, 2016
First Posted Date September 8, 2016
Last Update Posted Date January 7, 2019
Study Start Date September 2016
Actual Primary Completion Date November 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 1, 2016)
  • Above-threshold Medication Level Variability Index (MLVI) [ Time Frame: 6 months post enrollment ]
    Defined by an MLVI greater than 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.
  • 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.
  • Parent PTSS Total Score [ Time Frame: At enrollment visit ]
    Measured using the Impact of Event Scale (IES) self-report questionnaire.
  • Parent Avoidance [ Time Frame: At enrollment visit ]
    Measured using IES self-report questionnaire subscore.
  • Diagnosis of chronic allograft rejection [ Time Frame: 6 months retrospective data to 6 months post enrollment ]
  • Diagnosis of graft failure [ Time Frame: 6 months retrospective data to 6 months post enrollment ]
  • 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.
  • 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.
  • QOL Assessment Using PedsQL Subscale Scores [ Time Frame: At enrollment visit ]
    Measured using the child self-report PedsQL version 4.0 subscale scores.
  • 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.
  • 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.
  • 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.
  • 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).
  • Types of traumas identified as salient by the parent [ Time Frame: At enrollment visit ]
    Measured using the parent/guardian Impact of Event Scale (IES).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 1, 2016)
  • 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.
  • Exploratory Outcome: Presence of Donor Specific Antibodies (DSA) [ Time Frame: At enrollment Visit ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population Adolescent transplant recipients at risk for non-adherence and can reliably answer self-report questionnaires.
Condition
  • Solid Organ Transplant Recipients
  • Parent(s)/Guardian of Referenced Transplant Recipients
Intervention Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs
Study Groups/Cohorts 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)
Intervention: Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2019)
124
Original Estimated Enrollment
 (submitted: September 1, 2016)
120
Actual Study Completion Date November 24, 2018
Actual Primary Completion Date November 24, 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02892266
Other Study ID Numbers DAIT CTOTC-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study 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
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date January 2019