Solid Organ Transplant RecipientsCTOTC-11NCT02892266
Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients
An observational study of Solid Organ Transplant Recipients and Parent(s)/Guardian of Referenced Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Solid Organ Transplant Recipients, Parent(s)/Guardian of Referenced Transplant Recipients
- What is being tested?
- Assessment of adherence, mental health, behavioral, quality of life and biological constructs
- How many people
- 124 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2016to 24 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Adolescent transplant recipients at risk for non-adherence and can reliably answer self-report questionnaires.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Boston Children's Hospital: Pediatric Transplantation
Boston, Massachusetts, 02215
Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center: Pediatric Transplantation
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation
Dallas, Texas, 75235
Texas Children's Hospital: Pediatric Transplantation
Houston, Texas, 77030
Ronald Reagan UCLA Medical Center: Pediatric Transplantation
Los Angeles, California, 90095
University of Miami, Jackson Memorial Hospital: Pediatric Transplantation
Miami, Florida, 33136
Columbia University Medical Center: Pediatric Transplantation
New York, New York, 10032
Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation
Palo Alto, California, 94304
Children's Hospital of Philadelphia: Pediatric Transplantation
Philadelphia, Pennsylvania, 19104
UCSF Benioff Children's Hospital: Pediatric Transplantation
San Francisco, California, 94143
St. Louis Children's Hospital: Pediatric Transplantation
St Louis, Missouri, 63110
About this study
Official title: 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.
- Being tested
- Assessment of adherence, mental health, behavioral, quality of life and biological constructs
- Keywords
- Transplant recipients, Adolescents, Post-Traumatic Stress Symptoms (PTSS), Transplant Recipient and Family Impact(s)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of adherence, mental health, behavioral, quality of life and biological constructsOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At enrollment visit
Secondary outcomes (15)
Above-threshold Medication Level Variability Index (MLVI)
Defined by an MLVI greater than 2.
Measured: 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.
Measured: At enrollment visit
Child Avoidance Score
Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score.
Measured: At enrollment visit
Parent PTSS Total Score
Measured using the Impact of Event Scale (IES) self-report questionnaire.
Measured: At enrollment visit
Parent Avoidance
Measured using IES self-report questionnaire subscore.
Measured: At enrollment visit
Diagnosis of chronic allograft rejection
Measured: 6 months retrospective data to 6 months post enrollment
Diagnosis of graft failure
Measured: 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.
Measured: 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.
Measured: At enrollment visit
QOL Assessment Using PedsQL Subscale Scores
Measured using the child self-report PedsQL version 4.0 subscale scores.
Measured: 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.
Measured: At enrollment visit
PedsQL Family Impact Total Score
Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 summary score.
Measured: At enrollment visit
PedsQL Family Impact Subscale Scores
Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 subscale scores.
Measured: 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).
Measured: At enrollment visit
Types of traumas identified as salient by the parent
Measured using the parent/guardian Impact of Event Scale (IES).
Measured: At enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion24 Nov 2018
- Study completion24 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation in Children
- Responsible party
- Sponsor
- Investigators
- Stuart Sweet, M.D., Ph.D., Study chair, St. Louis Children's Hospital: Pediatric Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892266
- Sponsor's protocol ID
- DAIT CTOTC-11
- Acronym
- CTOTC-11
- Status last verified
- Jan 2019
- First submitted
- 11 Aug 2016
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Correlates of Post-Traumatic Stress Symptoms (PTSS) in Adolescent Solid Organ Transplant Recipients (CTOTC-11)
- ClinicalTrials.gov ID
- NCT02892266
- Acronym / sponsor ID
- CTOTC-11 / DAIT CTOTC-11
- Keywords
- Transplant recipients, Adolescents, Post-Traumatic Stress Symptoms (PTSS), Transplant Recipient and Family Impact(s)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Clinical Trials in Organ Transplantation in Children
- Study start
- Sep 2016
- Primary completion
- 24 Nov 2018 (actual)
- Study completion
- 24 Nov 2018 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent Transplant Recipients | – | Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs1. 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) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Adolescent transplant recipients at risk for non-adherence and can reliably answer self-report questionnaires.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of adherence, mental health, behavioral, quality of life and biological constructs | Other | Adolescent Transplant Recipients |
Primary outcome
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.
15 secondary outcomes
Above-threshold Medication Level Variability Index (MLVI)
Time frame: 6 months post enrollment
Above-threshold Child PTSS Score
Time frame: At enrollment visit
Child Avoidance Score
Time frame: At enrollment visit
Parent PTSS Total Score
Time frame: At enrollment visit
Parent Avoidance
Time frame: At enrollment visit
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
Quality of Life (QOL) Assessment Using the PedsQL Total Score
Time frame: At enrollment visit
QOL Assessment Using PedsQL Subscale Scores
Time frame: At enrollment visit
QOL Assessment Using the HRQOL (PedsQL) Total Score
Time frame: At enrollment visit
PedsQL Family Impact Total Score
Time frame: At enrollment visit
PedsQL Family Impact Subscale Scores
Time frame: At enrollment visit
Types of traumas identified as salient by the child
Time frame: At enrollment visit
Types of traumas identified as salient by the parent
Time frame: At enrollment visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- The National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- The Clinical Trials in Organ Transplantation in Children (CTOT-C)Link provided by the sponsor.
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Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Sweet, M.D., Ph.D. study chair
St. Louis Children's Hospital: Pediatric Transplantation
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Organ Transplant Recipients and Parent(s)/Guardian of Referenced Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Level Variability Index (MLVI) (time frame: 6 months retrospective data to 6 months post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.