Prevalence and Correlates of Post-Traumatic Stress Symptoms (PTSS) in Adolescent Solid Organ Transplant Recipients (CTOTC-11)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 13
- 主要终点
- Medication Level Variability Index (MLVI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Medication Level Variability Index (MLVI)
时间窗: 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
时间窗: 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.
次要结局
- Child Depression/Distress Assessment(At enrollment visit)
- Above-threshold Medication Level Variability Index (MLVI)(6 months post enrollment)
- Diagnosis of chronic allograft rejection(6 months retrospective data to 6 months post enrollment)
- QOL Assessment Using PedsQL Subscale Scores(At enrollment visit)
- Above-threshold Child PTSS Score(At enrollment visit)
- Child Avoidance Score(At enrollment visit)
- Diagnosis of graft failure(6 months retrospective data to 6 months post enrollment)
- Parent PTSS Total Score(At enrollment visit)
- QOL Assessment Using the HRQOL (PedsQL) Total Score(At enrollment visit)
- Parent Avoidance(At enrollment visit)
- Quality of Life (QOL) Assessment Using the PedsQL Total Score(At enrollment visit)
- PedsQL Family Impact Total Score(At enrollment visit)
- PedsQL Family Impact Subscale Scores(At enrollment visit)
- Types of traumas identified as salient by the parent(At enrollment visit)
- Types of traumas identified as salient by the child(At enrollment visit)