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| Name | Class |
|---|---|
| Clinical Trials in Organ Transplantation in Children | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescent Transplant Recipients |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assessment of adherence, mental health, behavioral, quality of life and biological constructs | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At enrollment visit |
| Measure | Description | Time Frame |
|---|---|---|
| Above-threshold Medication Level Variability Index (MLVI) | Defined by an MLVI greater than 2. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome: Dose of steroids | Potential impact of steroid use on PTSD will be assessed by a correlation coefficient between mean steroid dose per kilogram. | At enrollment |
| Exploratory Outcome: Presence of Donor Specific Antibodies (DSA) |
Inclusion Criteria:
The patient:
Exclusion Criteria:
The patient:
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Adolescent transplant recipients at risk for non-adherence and can reliably answer self-report questionnaires.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Sweet, M.D., Ph.D. | St. Louis Children's Hospital: Pediatric Transplantation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center: Pediatric Transplantation | Los Angeles | California | 90095 | United States | ||
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| Label | URL |
|---|---|
| The National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| Division of Allergy, Immunology, and Transplantation (DAIT) | View source |
| The Clinical Trials in Organ Transplantation in Children (CTOT-C) |
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Blood
| At enrollment visit |
| Child Avoidance Score | Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score. | At enrollment visit |
| Parent PTSS Total Score | Measured using the Impact of Event Scale (IES) self-report questionnaire. | At enrollment visit |
| Parent Avoidance | Measured using IES self-report questionnaire subscore. | At enrollment visit |
| Diagnosis of chronic allograft rejection | 6 months retrospective data to 6 months post enrollment |
| Diagnosis of graft failure | 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. | 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. | At enrollment visit |
| QOL Assessment Using PedsQL Subscale Scores | Measured using the child self-report PedsQL version 4.0 subscale scores. | 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. | At enrollment visit |
| PedsQL Family Impact Total Score | Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 summary score. | At enrollment visit |
| PedsQL Family Impact Subscale Scores | Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 subscale scores. | 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). | At enrollment visit |
| Types of traumas identified as salient by the parent | Measured using the parent/guardian Impact of Event Scale (IES). | At enrollment visit |
| At enrollment Visit |
| Lucile Salter Packard Children's Hospital at Stanford: Pediatric Transplantation |
| Palo Alto |
| California |
| 94304 |
| United States |
| UCSF Benioff Children's Hospital: Pediatric Transplantation | San Francisco | California | 94143 | United States |
| University of Miami, Jackson Memorial Hospital: Pediatric Transplantation | Miami | Florida | 33136 | United States |
| Ann and Robert H. Lurie Children's Hospital of Chicago: Pediatric Transplantation | Chicago | Illinois | 60611 | United States |
| Boston Children's Hospital: Pediatric Transplantation | Boston | Massachusetts | 02215 | United States |
| St. Louis Children's Hospital: Pediatric Transplantation | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center: Pediatric Transplantation | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital Medical Center: Pediatric Transplantation | Cincinnati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Children's Hospital of Philadelphia: Pediatric Transplantation | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Southwestern/Children's Medical Center: Pediatric Transplantation | Dallas | Texas | 75235 | United States |
| Texas Children's Hospital: Pediatric Transplantation | Houston | Texas | 77030 | United States |
| View source |
| ID | Term |
|---|---|
| D008603 | Mental Health |
| D011788 | Quality of Life |
| ID | Term |
|---|---|
| D006262 | Health |
| D011154 | Population Characteristics |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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