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

Recruiting

• Conditions: Transplant-Related Disorder
• Interventions: Procedure: Allogeneic hematopoietic stem cell transplantation; Procedure: Solid organ transplantation

• Registration Number: NCT05441436
• Lead Sponsor: Hospital Universitario La Paz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-26
• Status Verified: 2022-06
• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-27
• Last Update Submitted: 2022-06-27
• Study First Posted: 2022-07-01
• Last Update Posted: 2022-07-01
• Primary Completion: 2025-05-26
• Study Completion: 2025-05-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allogeneic hematopoietic stem cell transplantation	Allogeneic hematopoietic stem cell transplantation	Patients in waiting list for and after allogeneic hematopoietic stem cell transplantation.
Solid organ transplantation	Solid organ transplantation	Patients in waiting list for and after solid organ transplantation.

Primary Outcome Measures

Name	Time	Method
Conners Continuous Auditory Test of Attention (CATA)	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.
Spanish version of the California Verbal Learning Test (TAVEC)	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 B	6 months	It assesses intellectual functioning free of cultural influences by the total number of items achieved.
Symbol Digit Modalities Test (SDMT)	6 months	It assesses processing speed by the total number of items achieved.
Test of Nonverbal Intelligence, Fourth Edition (TONI-4) form A	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	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	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)	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	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)	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)	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)	6 months	It measures semantic memory by the total number of items achieved.
Fluency Verbal Test (TFV)	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)	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)	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)	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)	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.

Trial Locations

Locations (2)

Hospital Universitario La Paz. Hospital infantil; 🇪🇸 Madrid, Spain

University of Málaga; 🇪🇸 Málaga, Spain