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Completed

NCT Number: NCT02892266

Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients

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.

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Key information

Conditions

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

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ronald Reagan UCLA Medical Center: Pediatric Transplantation, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Clinical Trials in Organ Transplantation in Children

Registry information

Official study title

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

Acronym: CTOTC-11

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 8, 2016
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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