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临床试验/NCT05441436
NCT05441436招募中不适用

Identification of Needs and Neuropsychological and Biopsychosocial Evolution in the Pre/Post-transplant and 6-month Follow-up Phases in Pediatric Population (the TransplantKIDS Mental Health Project)

Hospital Universitario La Paz2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form B

研究概览

简要总结

This pioneering prospective observational study aims to examine biopsychosocial and neuropsychological functioning, care needs and predictors of therapeutic adherence in children/adolescents in pre/post-surgical transplant (solid organ or allogeneic haematopoietic stem cell) phases. Hypothesis: H1. Differences in biopsychosocial and neuropsychological functioning and adherence will be observed between transplant types; H2. Executive functioning will mediate the relationship between anxiety, sleep disturbance and pain intensity/interference and adherence; H3. There will be a significant improvement in different neuropsychological indicators 6 months post-transplantation. Sample: patients (8-18 years) extracted by non-probabilistic sampling, estimating a sample size of 60 patients (30 for each type of transplant, organ and haematopoietic) from Hospital Universitario La Paz (Madrid). Individual pre/post-surgical assessments will be carried out (after 2 and 4 weeks), as well as at 6 months post-transplant, both in person (neurocognitive) and through the secure platform REDCap (completed by patients and their legal guardians). Finally, focus groups will be conducted among patients, their relatives and medical-surgical professionals to identify barriers to therapeutic adherence and unmet care needs during the pre-, peri- and post-surgical process.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Spanish as mother tongue or a very high level of Spanish in order to understand their participation in the study, as well as to be able to complete the measurement instruments.

排除标准

  • Diagnosis of intellectual disability, autism spectrum disorder or acquired brain damage.
  • Diagnosis of uncontrolled/stabilised comorbid disease, independent of the disease motivating the transplantation process.

结局指标

主要结局

Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form B

时间窗: 6 months

It assesses intellectual functioning free of cultural influences by the total number of items achieved.

Spanish version of the California Verbal Learning Test (TAVEC)

时间窗: 6 months

Assessment of verbal memory for adolescents 16 to 18 years old by the maximum number of remembered elements.

Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form A

时间窗: Baseline

It assesses intellectual functioning free of cultural influences by the total number of items achieved.

Digit span subtests from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV): Forward, Backward and Sequencing subtests

时间窗: 6 months

It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements.

The Rey-Osterrieth Complex Figure (ROCF) test

时间窗: 6 months

It measures viso-constructive organisational ability and immediate and delayed visual recall. One point is awarded for each component that is properly reproduced.

Pediatric Sleep Disturbances Short Form (PROMIS)

时间窗: 6 months

A 4-item questionnaire that assesses problems with sleep reconciliation and sleep maintenance in the last 7 days. Higher scores on a Likert scale from 1-5 indicate worse sleep.

Initial survey created ad hoc

时间窗: Baseline

Both sociodemographic variables (sex, age, patient's level of studies, parents' level of studies) and clinical variables (current pharmacological treatment - active ingredient and dose) will be collected.

Behavior Rating Inventory of Executive Function - 2 (BRIEF-2)

时间窗: 6 months

A 63-item questionnaire that assesses patient's executive functions (completed by parents). Higher scores in each domain indicate a worse outcome. Spanish norms in T scores (Mean = 50; standard deviation = 10).

Spanish version of the California Verbal Learning Test for children (TAVECI)

时间窗: 6 months

Assessment of verbal memory in children 3 to 16 years old by the maximum number of remembered elements.

Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)

时间窗: 6 months

It measures semantic memory by the total number of items achieved.

Symbol Digit Modalities Test (SDMT)

时间窗: 6 months

It assesses processing speed by the total number of items achieved.

Conners Continuous Auditory Test of Attention (CATA)

时间窗: 6 months

It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility.

Fluency Verbal Test (TFV)

时间窗: 6 months

It assesses linguistic-executive functions such as phonological fluency and semantic fluency. One point is awarded for each word that is correctly produced.

Behavioral Assessment System for Children - 3 (BASC-3)

时间窗: 6 months

It measures patients' emotional and behavioural problems, both in its version by the patient's legal guardians and self-reported by the patient. It is an 139-item report, rated on a 4-point frequency Likert scale. High scores indicate problematic levels of functioning. Spanish norms in T scores (Mean = 50; standard deviation = 10).

Brief Pain Inventory (BPI)

时间窗: 6 months

This 10-item questionnaire includes questions (from 0 to 10 referring to the last 7 days) covering two dimensions: pain intensity (worst and mildest pain in the week, average pain, and current pain), and pain interference (with general activity, mood, walking, school, sleep, as well as enjoyment of life). Higher scores on a Likert scale from 0-10 indicate more pain.

Adolescent Insomnia Questionnaire (AIQ)

时间窗: 6 months

It is a 13-item questionnaire whose original version is in English. In the present study, this questionnaire will be adapted and validated into Spanish. Higher scores on a Likert scale from 0-4 indicate more insomnia.

Simplified Medication Adherence Questionnaire (SMAQ)

时间窗: 6 months

A 6-item self-report that measures adherence to medication. For items 1-4 yes or no answers are required. Item 5 requires a multiple choice answer in terms of frequency (5 different options are provided). Item 6 requires a number input. The final score is a dichotomous variable: non-adherent versus adherent patient.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Eduardo Fernández-Jiménez

Principal Investigator

Hospital Universitario La Paz

研究点 (2)

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