Transplant-Related DisorderNCT05441436
Neuropsychological and Biopsychosocial Evolution During Pediatric Transplantation: Pre/Post-stages and at 6 Months
An observational study of Transplant-Related Disorder, run by Hospital Universitario La Paz at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Transplant-Related Disorder
- What is being tested?
- Allogeneic hematopoietic stem cell transplantation and Solid organ transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 26 May 2022to 26 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 1 recruiting
- Recruiting
Hospital Universitario La Paz. Hospital infantil
Madrid, 28046
Eduardo Fernández Jiménez, PhD, +34630305521498401, eduferjim.psyc@gmail.com
María Fe Bravo Ortiz, PhD
- Active, not recruiting
University of Málaga
Málaga, 29071
About this study
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)
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.
- Conditions
- Transplant-Related Disorder
- Being tested
- Allogeneic hematopoietic stem cell transplantation, Solid organ transplantation
- Keywords
- Pediatric Solid Organ Transplant, Pediatric Allogeneic Hematopoietic Transplant, Neuropsychology, Biopsychosocial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic hematopoietic stem cell transplantationProcedure or surgery
Allogeneic hematopoietic stem cell transplantation
Solid organ transplantationProcedure or surgery
Solid organ transplantation
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic hematopoietic stem cell transplantation | Patients in waiting list for and after allogeneic hematopoietic stem cell transplantation. Receives: Procedure: Allogeneic hematopoietic stem cell transplantation | |
| Solid organ transplantation | Patients in waiting list for and after solid organ transplantation. Receives: Procedure: Solid organ transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial survey created ad hoc
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.
Measured: Baseline
Behavior Rating Inventory of Executive Function - 2 (BRIEF-2)
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).
Measured: Baseline
Behavior Rating Inventory of Executive Function - 2 (BRIEF-2)
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).
Measured: 6 months
Spanish version of the California Verbal Learning Test for children (TAVECI)
Assessment of verbal memory in children 3 to 16 years old by the maximum number of remembered elements.
Measured: Baseline
Spanish version of the California Verbal Learning Test (TAVEC)
Assessment of verbal memory for adolescents 16 to 18 years old by the maximum number of remembered elements.
Measured: Baseline
Spanish version of the California Verbal Learning Test for children (TAVECI)
Assessment of verbal memory in children 3 to 16 years old by the maximum number of remembered elements.
Measured: 6 months
Spanish version of the California Verbal Learning Test (TAVEC)
Assessment of verbal memory for adolescents 16 to 18 years old by the maximum number of remembered elements.
Measured: 6 months
Conners Continuous Auditory Test of Attention (CATA)
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility.
Measured: Baseline
Conners Continuous Auditory Test of Attention (CATA)
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility.
Measured: 4 weeks
Conners Continuous Auditory Test of Attention (CATA)
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility.
Measured: 6 months
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form A
It assesses intellectual functioning free of cultural influences by the total number of items achieved.
Measured: Baseline
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form B
It assesses intellectual functioning free of cultural influences by the total number of items achieved.
Measured: 6 months
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
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements.
Measured: Baseline
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
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements.
Measured: 4 weeks
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
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements.
Measured: 6 months
Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)
It measures semantic memory by the total number of items achieved.
Measured: Baseline
Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)
It measures semantic memory by the total number of items achieved.
Measured: 6 months
Symbol Digit Modalities Test (SDMT)
It assesses processing speed by the total number of items achieved.
Measured: Baseline
Symbol Digit Modalities Test (SDMT)
It assesses processing speed by the total number of items achieved.
Measured: 4 weeks
Symbol Digit Modalities Test (SDMT)
It assesses processing speed by the total number of items achieved.
Measured: 6 months
The Rey-Osterrieth Complex Figure (ROCF) test
It measures viso-constructive organisational ability and immediate and delayed visual recall. One point is awarded for each component that is properly reproduced.
Measured: Baseline
The Rey-Osterrieth Complex Figure (ROCF) test
It measures viso-constructive organisational ability and immediate and delayed visual recall. One point is awarded for each component that is properly reproduced.
Measured: 6 months
Fluency Verbal Test (TFV)
It assesses linguistic-executive functions such as phonological fluency and semantic fluency. One point is awarded for each word that is correctly produced.
Measured: Baseline
Fluency Verbal Test (TFV)
It assesses linguistic-executive functions such as phonological fluency and semantic fluency. One point is awarded for each word that is correctly produced.
Measured: 6 months
Behavioral Assessment System for Children - 3 (BASC-3)
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).
Measured: Baseline
Behavioral Assessment System for Children - 3 (BASC-3)
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).
Measured: 6 months
Brief Pain Inventory (BPI)
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.
Measured: Baseline
Brief Pain Inventory (BPI)
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.
Measured: 2 weeks
Brief Pain Inventory (BPI)
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.
Measured: 4 weeks
Brief Pain Inventory (BPI)
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.
Measured: 6 months
Adolescent Insomnia Questionnaire (AIQ)
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.
Measured: Baseline
Adolescent Insomnia Questionnaire (AIQ)
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.
Measured: 2 weeks
Adolescent Insomnia Questionnaire (AIQ)
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.
Measured: 4 weeks
Adolescent Insomnia Questionnaire (AIQ)
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.
Measured: 6 months
Pediatric Sleep Disturbances Short Form (PROMIS)
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.
Measured: Baseline
Pediatric Sleep Disturbances Short Form (PROMIS)
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.
Measured: 2 weeks
Pediatric Sleep Disturbances Short Form (PROMIS)
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.
Measured: 4 weeks
Pediatric Sleep Disturbances Short Form (PROMIS)
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.
Measured: 6 months
Simplified Medication Adherence Questionnaire (SMAQ)
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.
Measured: Baseline
Simplified Medication Adherence Questionnaire (SMAQ)
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.
Measured: 2 weeks
Simplified Medication Adherence Questionnaire (SMAQ)
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.
Measured: 4 weeks
Simplified Medication Adherence Questionnaire (SMAQ)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start26 May 2022
- Primary completion26 May 2025 (estimated)
- Study completion26 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transplant-Related DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaga
- Responsible party
- Principal investigator, Dr. Eduardo Fernández-Jiménez, Hospital Universitario La Paz
- Investigators
- Eduardo Fernández-Jiménez, PhD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441436
- Sponsor's protocol ID
- 5223
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garrido-Bolton J, de la Vega R, Bravo-Ortiz MF, Fernandez-Jimenez E. Experiences of parents and adolescents throughout the solid-organ transplantation process: a focus group study. Front Psychiatry. 2026 Aug 5;17:1633641. doi: 10.3389/fpsyt.2026.1633641. eCollection 2026.
PubMed 42621938Garrido-Bolton J, Alcami-Pertejo M, de la Vega R, Hernandez-Oliveros F, Perez-Martinez A, Bravo-Ortiz MF, Fernandez-Jimenez E. Neuropsychological and biopsychosocial evolution, therapeutic adherence and unmet care needs during paediatric transplantation: study protocol of a mixed-methods design (observational cohort study and focus groups) - the TransplantKIDS mental health project. Front Psychol. 2024 Feb 21;15:1308418. doi: 10.3389/fpsyg.2024.1308418. eCollection 2024.
PubMed 38449767
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05441436
- Acronym / sponsor ID
- 5223
- Conditions
- Transplant-Related Disorder
- Keywords
- Pediatric Solid Organ Transplant, Pediatric Allogeneic Hematopoietic Transplant, Neuropsychology, Biopsychosocial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- University of Malaga
- Study start
- 26 May 2022 (actual)
- Primary completion
- 26 May 2025 (estimated)
- Study completion
- 26 May 2025 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic hematopoietic stem cell transplantation | – | Procedure: Allogeneic hematopoietic stem cell transplantationPatients in waiting list for and after allogeneic hematopoietic stem cell transplantation. |
| Solid organ transplantation | – | Procedure: Solid organ transplantationPatients in waiting list for and after solid organ transplantation. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic hematopoietic stem cell transplantationAllogeneic hematopoietic stem cell transplantation | Procedure or surgery | Allogeneic hematopoietic stem cell transplantation |
| Solid organ transplantationSolid organ transplantation | Procedure or surgery | Solid organ transplantation |
Primary outcome
Initial survey created ad hoc
Time frame: 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)
Time frame: Baseline
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).
Behavior Rating Inventory of Executive Function - 2 (BRIEF-2)
Time frame: 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)
Time frame: Baseline
Assessment of verbal memory in children 3 to 16 years old by the maximum number of remembered elements.
Spanish version of the California Verbal Learning Test (TAVEC)
Time frame: Baseline
Assessment of verbal memory for adolescents 16 to 18 years old by the maximum number of remembered elements.
Spanish version of the California Verbal Learning Test for children (TAVECI)
Time frame: 6 months
Assessment of verbal memory in children 3 to 16 years old by the maximum number of remembered elements.
Spanish version of the California Verbal Learning Test (TAVEC)
Time frame: 6 months
Assessment of verbal memory for adolescents 16 to 18 years old by the maximum number of remembered elements.
Conners Continuous Auditory Test of Attention (CATA)
Time frame: Baseline
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility.
Conners Continuous Auditory Test of Attention (CATA)
Time frame: 4 weeks
It measures auditory sustained attention. Omissions and commissions are measured for 5 different dimensions: inattentiveness, impulsivity, sustained attention, auditory laterality and auditory mobility.
Conners Continuous Auditory Test of Attention (CATA)
Time frame: 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.
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form A
Time frame: Baseline
It assesses intellectual functioning free of cultural influences by the total number of items achieved.
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form B
Time frame: 6 months
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
Time frame: Baseline
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements.
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
Time frame: 4 weeks
It evaluates span of immediate recall and verbal working memory by the total number of items achieved and the maximum number of remembered elements.
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
Time frame: 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.
Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)
Time frame: Baseline
It measures semantic memory by the total number of items achieved.
Vocabulary subtest from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or the Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)
Time frame: 6 months
It measures semantic memory by the total number of items achieved.
Symbol Digit Modalities Test (SDMT)
Time frame: Baseline
It assesses processing speed by the total number of items achieved.
Symbol Digit Modalities Test (SDMT)
Time frame: 4 weeks
It assesses processing speed by the total number of items achieved.
Symbol Digit Modalities Test (SDMT)
Time frame: 6 months
It assesses processing speed by the total number of items achieved.
The Rey-Osterrieth Complex Figure (ROCF) test
Time frame: Baseline
It measures viso-constructive organisational ability and immediate and delayed visual recall. One point is awarded for each component that is properly reproduced.
The Rey-Osterrieth Complex Figure (ROCF) test
Time frame: 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.
Fluency Verbal Test (TFV)
Time frame: Baseline
It assesses linguistic-executive functions such as phonological fluency and semantic fluency. One point is awarded for each word that is correctly produced.
Fluency Verbal Test (TFV)
Time frame: 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)
Time frame: Baseline
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).
Behavioral Assessment System for Children - 3 (BASC-3)
Time frame: 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)
Time frame: Baseline
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.
Brief Pain Inventory (BPI)
Time frame: 2 weeks
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.
Brief Pain Inventory (BPI)
Time frame: 4 weeks
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.
Brief Pain Inventory (BPI)
Time frame: 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)
Time frame: Baseline
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.
Adolescent Insomnia Questionnaire (AIQ)
Time frame: 2 weeks
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.
Adolescent Insomnia Questionnaire (AIQ)
Time frame: 4 weeks
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.
Adolescent Insomnia Questionnaire (AIQ)
Time frame: 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.
Pediatric Sleep Disturbances Short Form (PROMIS)
Time frame: Baseline
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.
Pediatric Sleep Disturbances Short Form (PROMIS)
Time frame: 2 weeks
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.
Pediatric Sleep Disturbances Short Form (PROMIS)
Time frame: 4 weeks
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.
Pediatric Sleep Disturbances Short Form (PROMIS)
Time frame: 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.
Simplified Medication Adherence Questionnaire (SMAQ)
Time frame: Baseline
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.
Simplified Medication Adherence Questionnaire (SMAQ)
Time frame: 2 weeks
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.
Simplified Medication Adherence Questionnaire (SMAQ)
Time frame: 4 weeks
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.
Simplified Medication Adherence Questionnaire (SMAQ)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Derived from this study: PubMed 42621938Garrido-Bolton J, de la Vega R, Bravo-Ortiz MF, Fernandez-Jimenez E. Experiences of parents and adolescents throughout the solid-organ transplantation process: a focus group study. Front Psychiatry. 2026 Aug 5;17:1633641. doi: 10.3389/fpsyt.2026.1633641. eCollection 2026.
- Derived from this study: PubMed 38449767Garrido-Bolton J, Alcami-Pertejo M, de la Vega R, Hernandez-Oliveros F, Perez-Martinez A, Bravo-Ortiz MF, Fernandez-Jimenez E. Neuropsychological and biopsychosocial evolution, therapeutic adherence and unmet care needs during paediatric transplantation: study protocol of a mixed-methods design (observational cohort study and focus groups) - the TransplantKIDS mental health project. Front Psychol. 2024 Feb 21;15:1308418. doi: 10.3389/fpsyg.2024.1308418. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Fernández-Jiménez, PhD principal investigator
Hospital Universitario La Paz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant-Related Disorder, run by Hospital Universitario La Paz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Fernández-Jiménez, PhD (+34630305521498401, eduferjim.psyc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial survey created ad hoc (time frame: Baseline). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05441436, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.