Neuropsychological and Biopsychosocial Evolution During Pediatric Transplantation: Pre/Post-stages and at 6 Months

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.

Study Overview

• Status: Recruiting
• Conditions: Transplant-Related Disorder
• Intervention / Treatment: Procedure: Allogeneic hematopoietic stem cell transplantation; Procedure: Solid organ transplantation

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Eduardo Fernández-Jiménez, PhD; Phone Number: +34630305521498401; Email: eduferjim.psyc@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz. Hospital infantil
    • Contact: Eduardo Fernández Jiménez, PhD; Phone Number: +34630305521498401; Email: eduferjim.psyc@gmail.com
    • Sub-Investigator: María Fe Bravo Ortiz, PhD
    • Sub-Investigator: Margarita Alcamí Pertejo, PhD
    • Sub-Investigator: Antonio Pérez Martínez, PhD
    • Sub-Investigator: Francisco Hernández Oliveros, PhD
    • Sub-Investigator: Arancha Ortiz Villalobos, MD
    • Sub-Investigator: Jessica Garrido Bolton, MSc
  • Málaga, Spain, 29071
    • Active, not recruiting
    • University of Malaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Allogeneic hematopoietic stem cell transplantation; Patients in waiting list for and after allogeneic hematopoietic stem cell transplantation.	Procedure: Allogeneic hematopoietic stem cell transplantation; Allogeneic hematopoietic stem cell transplantation
Solid organ transplantation; Patients in waiting list for and after solid organ transplantation.	Procedure: Solid organ transplantation; Solid organ transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	6 months
Symbol Digit Modalities Test (SDMT)	It assesses processing speed by the total number of items achieved.	Baseline
Symbol Digit Modalities Test (SDMT)	It assesses processing speed by the total number of items achieved.	4 weeks
Symbol Digit Modalities Test (SDMT)	It assesses processing speed by the total number of items achieved.	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.	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.	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.	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.	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	6 months

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz
• Collaborators: University of Malaga
• Investigators: Principal Investigator: Eduardo Fernández-Jiménez, PhD, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Anticipated): May 26, 2025
• Study Completion (Anticipated): May 26, 2025

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Neuropsychology; Biopsychosocial; Pediatric Solid Organ Transplant; Pediatric Allogeneic Hematopoietic Transplant
• Other Study ID Numbers: 5223

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No