Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT02892266
Status:
COMPLETED
Last Update Posted:
2019-01-07
First Post:
2016-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008603', 'term': 'Mental Health'}, {'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-04', 'studyFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2016-09-01', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Outcome: Dose of steroids', 'timeFrame': 'At enrollment', 'description': 'Potential impact of steroid use on PTSD will be assessed by a correlation coefficient between mean steroid dose per kilogram.'}, {'measure': 'Exploratory Outcome: Presence of Donor Specific Antibodies (DSA)', 'timeFrame': 'At enrollment Visit'}], 'primaryOutcomes': [{'measure': 'Medication Level Variability Index (MLVI)', 'timeFrame': '6 months retrospective data to 6 months post enrollment', 'description': '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.'}, {'measure': 'University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 (UCLA PTSD RI DSM-5) Total Score', 'timeFrame': 'At enrollment visit', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Above-threshold Medication Level Variability Index (MLVI)', 'timeFrame': '6 months post enrollment', 'description': 'Defined by an MLVI greater than 2.'}, {'measure': 'Above-threshold Child PTSS Score', 'timeFrame': 'At enrollment visit', 'description': '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.'}, {'measure': 'Child Avoidance Score', 'timeFrame': 'At enrollment visit', 'description': 'Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score.'}, {'measure': 'Parent PTSS Total Score', 'timeFrame': 'At enrollment visit', 'description': 'Measured using the Impact of Event Scale (IES) self-report questionnaire.'}, {'measure': 'Parent Avoidance', 'timeFrame': 'At enrollment visit', 'description': 'Measured using IES self-report questionnaire subscore.'}, {'measure': 'Diagnosis of chronic allograft rejection', 'timeFrame': '6 months retrospective data to 6 months post enrollment'}, {'measure': 'Diagnosis of graft failure', 'timeFrame': '6 months retrospective data to 6 months post enrollment'}, {'measure': 'Child Depression/Distress Assessment', 'timeFrame': 'At enrollment visit', 'description': "Depression/distress measured using the Children's Depression Inventory - Short Form (CDI-S) self-report questionnaire."}, {'measure': 'Quality of Life (QOL) Assessment Using the PedsQL Total Score', 'timeFrame': 'At enrollment visit', 'description': 'Measured using the child self-report Pediatric Quality of Life (PedsQL) version 4.0.'}, {'measure': 'QOL Assessment Using PedsQL Subscale Scores', 'timeFrame': 'At enrollment visit', 'description': 'Measured using the child self-report PedsQL version 4.0 subscale scores.'}, {'measure': 'QOL Assessment Using the HRQOL (PedsQL) Total Score', 'timeFrame': 'At enrollment visit', 'description': 'Measured using the child self-report Transplant-Specific Health-Related Quality of Life (HRQOL) scale (PedsQL) version 4.0 summary score.'}, {'measure': 'PedsQL Family Impact Total Score', 'timeFrame': 'At enrollment visit', 'description': 'Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 summary score.'}, {'measure': 'PedsQL Family Impact Subscale Scores', 'timeFrame': 'At enrollment visit', 'description': 'Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 subscale scores.'}, {'measure': 'Types of traumas identified as salient by the child', 'timeFrame': 'At enrollment visit', 'description': 'Measured using the University of California at Los Angeles Post-Traumatic Stress Disorder Reaction Index DSM-5 version (UCLA PTSD RI DSM-5).'}, {'measure': 'Types of traumas identified as salient by the parent', 'timeFrame': 'At enrollment visit', 'description': 'Measured using the parent/guardian Impact of Event Scale (IES).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transplant recipients', 'Adolescents', 'Post-Traumatic Stress Symptoms (PTSS)', 'Transplant Recipient and Family Impact(s)'], 'conditions': ['Solid Organ Transplant Recipients', 'Parent(s)/Guardian of Referenced Transplant Recipients']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.niaid.nih.gov/', 'label': 'The National Institute of Allergy and Infectious Diseases (NIAID)'}, {'url': 'https://www.niaid.nih.gov/about/dait', 'label': 'Division of Allergy, Immunology, and Transplantation (DAIT)'}, {'url': 'http://www.ctotc.org/', 'label': 'The Clinical Trials in Organ Transplantation in Children (CTOT-C)'}]}, 'descriptionModule': {'briefSummary': '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.\n\nTarget population: medically stable adolescent solid organ (e.g., heart, kidney, liver, lung, small bowel) transplant recipients and their parent(s)/guardian.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescent transplant recipients at risk for non-adherence and can reliably answer self-report questionnaires.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nThe patient:\n\n* and/or their parent(s)/guardian must be able to understand and provide informed consent in English or Spanish;\n* is prescribed tacrolimus (either brand or generic formulation); and\n* has been seen in the enrolling center's clinic at least twice in the last two years.\n\nExclusion Criteria:\n\nThe patient:\n\n* received a transplant less than 18 months prior to enrollment;\n* has had more than one transplant (including marrow replacement);\n* or their parent(s)/guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion);\n* 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);\n* is not medically stable or is hospitalized;\n* is currently enrolled in a study that aims to improve adherence to medical recommendations;\n* is receiving cognitive behavioral therapy for confirmed or suspected diagnosis of Post-Traumatic Stress Disorder (PTSD) at enrollment;\n* is receiving psychotropic medications for a confirmed or suspected diagnosis of PTSD."}, 'identificationModule': {'nctId': 'NCT02892266', 'acronym': 'CTOTC-11', 'briefTitle': 'Post-Traumatic Stress Symptoms (PTSS) in Transplant Recipients', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Prevalence and Correlates of Post-Traumatic Stress Symptoms (PTSS) in Adolescent Solid Organ Transplant Recipients (CTOTC-11)', 'orgStudyIdInfo': {'id': 'DAIT CTOTC-11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adolescent Transplant Recipients', 'description': "1. Questionnaire battery at enrollment (Participants and their parents/guardians)\n2. Clinical data from patient's chart (6 months of retrospective data \\& 6 months of prospective tacrolimus trough level data)", 'interventionNames': ['Other: Assessment of adherence, mental health, behavioral, quality of life and biological constructs']}], 'interventions': [{'name': 'Assessment of adherence, mental health, behavioral, quality of life and biological constructs', 'type': 'OTHER', 'armGroupLabels': ['Adolescent Transplant Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center: Pediatric Transplantation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital: Pediatric Transplantation", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Jackson Memorial Hospital: Pediatric Transplantation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital: Pediatric Transplantation", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital: Pediatric Transplantation", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center: Pediatric Transplantation', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center: Pediatric Transplantation", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia: Pediatric Transplantation", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital: Pediatric Transplantation", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Stuart Sweet, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': "St. Louis Children's Hospital: Pediatric Transplantation"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Clinical Trials in Organ Transplantation in Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}