Parent(s)/Guardian of Referenced Transplant Recipients, Solid Organ Transplant Recipients
Conditions
Keywords
Transplant recipients, Adolescents, Post-Traumatic Stress Symptoms (PTSS), Transplant Recipient and Family Impact(s)
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.
Interventions
OTHERAssessment of adherence, mental health, behavioral, quality of life and biological constructs
Sponsors
Clinical Trials in Organ Transplantation in Children
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Level Variability Index (MLVI) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Above-threshold Child PTSS Score | 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 | At enrollment visit | Measured by the UCLA Post-Traumatic Stress Disorder Reaction Index (PTSD-RI) self-report subscale summary score. |
| Parent PTSS Total Score | At enrollment visit | Measured using the Impact of Event Scale (IES) self-report questionnaire. |
| Parent Avoidance | At enrollment visit | Measured using IES self-report questionnaire subscore. |
| 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 | — |
| Quality of Life (QOL) Assessment Using the PedsQL Total Score | At enrollment visit | Measured using the child self-report Pediatric Quality of Life (PedsQL) version 4.0. |
| QOL Assessment Using PedsQL Subscale Scores | At enrollment visit | Measured using the child self-report PedsQL version 4.0 subscale scores. |
| QOL Assessment Using the HRQOL (PedsQL) Total Score | 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 | At enrollment visit | Measured using the parent/guardian self-report PedsQL Family Impact version 2.0 summary score. |
| PedsQL Family Impact Subscale Scores | 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 | 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 | At enrollment visit | Measured using the parent/guardian Impact of Event Scale (IES). |
| Child Depression/Distress Assessment | At enrollment visit | Depression/distress measured using the Children's Depression Inventory - Short Form (CDI-S) self-report questionnaire. |
| Above-threshold Medication Level Variability Index (MLVI) | 6 months post enrollment | Defined by an MLVI greater than 2. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Outcome: Dose of steroids | 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) | At enrollment Visit | — |
Countries
United States
Outcome results
None listed