Clinical trial NCT05441436: Neuropsychological and Biopsychosocial Evolution During Pediatric Transplantation: Pre/Post-stages and at 6 Months
Official title: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transplant-Related Disorder
Keywords: Pediatric Solid Organ Transplant
Pediatric Allogeneic Hematopoietic Transplant
Neuropsychology
Biopsychosocial
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: University of Malaga
First posted: 2022-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be all children and adolescents in the imminent phase of being included in the waiting list for a transplant of any solid organ (single or combined), or allogeneic haematopoietic stem cell.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Initial survey created ad hoc
timeFrame: Baseline
measure: Behavior Rating Inventory of Executive Function - 2 (BRIEF-2)
timeFrame: Baseline
measure: Behavior Rating Inventory of Executive Function - 2 (BRIEF-2)
timeFrame: 6 months
measure: Spanish version of the California Verbal Learning Test for children (TAVECI)
timeFrame: Baseline
measure: Spanish version of the California Verbal Learning Test (TAVEC)
timeFrame: Baseline
measure: Spanish version of the California Verbal Learning Test for children (TAVECI)
timeFrame: 6 months
measure: Spanish version of the California Verbal Learning Test (TAVEC)
timeFrame: 6 months
measure: Conners Continuous Auditory Test of Attention (CATA)
timeFrame: Baseline
measure: Conners Continuous Auditory Test of Attention (CATA)
timeFrame: 4 weeks
measure: Conners Continuous Auditory Test of Attention (CATA)
timeFrame: 6 months
measure: Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form A
timeFrame: Baseline
measure: Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form B
timeFrame: 6 months
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: 4 weeks
measure: 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
timeFrame: 6 months
measure: Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)
timeFrame: Baseline
measure: Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)
timeFrame: 6 months
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: 4 weeks
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: 6 months
measure: The Rey-Osterrieth Complex Figure (ROCF) test
timeFrame: Baseline
measure: The Rey-Osterrieth Complex Figure (ROCF) test
timeFrame: 6 months
measure: Fluency Verbal Test (TFV)
timeFrame: Baseline
measure: Fluency Verbal Test (TFV)
timeFrame: 6 months
measure: Behavioral Assessment System for Children - 3 (BASC-3)
timeFrame: Baseline
measure: Behavioral Assessment System for Children - 3 (BASC-3)
timeFrame: 6 months
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline
measure: Brief Pain Inventory (BPI)
timeFrame: 2 weeks
measure: Brief Pain Inventory (BPI)
timeFrame: 4 weeks
measure: Brief Pain Inventory (BPI)
timeFrame: 6 months
measure: Adolescent Insomnia Questionnaire (AIQ)
timeFrame: Baseline
measure: Adolescent Insomnia Questionnaire (AIQ)
timeFrame: 2 weeks
measure: Adolescent Insomnia Questionnaire (AIQ)
timeFrame: 4 weeks
measure: Adolescent Insomnia Questionnaire (AIQ)
timeFrame: 6 months
measure: Pediatric Sleep Disturbances Short Form (PROMIS)
timeFrame: Baseline
measure: Pediatric Sleep Disturbances Short Form (PROMIS)
timeFrame: 2 weeks
measure: Pediatric Sleep Disturbances Short Form (PROMIS)
timeFrame: 4 weeks
measure: Pediatric Sleep Disturbances Short Form (PROMIS)
timeFrame: 6 months
measure: Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: Baseline
measure: Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: 2 weeks
measure: Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: 4 weeks
measure: Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz. Hospital infantil
city: Málaga
country: Spain
facility: University of Málaga
Study officials:
affiliation: Hospital Universitario La Paz
name: Eduardo Fernández-Jiménez, PhD
role: PRINCIPAL_INVESTIGATOR
References: