Randomized Controlled Clinical Trial of Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy. The PsyCARTkids Project
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Sponsor: Hospital Universitario La Paz

 
 
 
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PSYCARTKIDS: BIO-PSYCHOLOGICAL IMPACT OF COGNITIVE 
TRAINING AND MINDFULNESS IN CHILDREN AFTER CAR-T 
THERAPY, HEMATOPOIETIC TRANSPLANTATION, OR 
CHEMOTHERAPY: MIXED METHODS STUDY AND RANDOMIZED 
CONTROLLED TRIAL. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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BACKGROUND  
 
This project has the objective of implement a randomized controlled clinical trial focused 
on telematic interventions for cognitive training and mindfulness-based emotional regulation, 
ending with a follow-up 6 months after treatment. 
 
Hematological and oncological diseases have a clinically significant impact on the 
mental health, biopsychological functioning, and neurodevelopment of the child and 
adolescent population affected by them. This assertion is especially applicable to children and 
adolescents who must undergo intensive therapies, such as high-dose chemotherapy or 
hematopoietic transplantation (hereinafter HPT); although survival rates have increased 
significantly, this has been achieved at the cost of greater morbidity in this clinical population 
(Di Giuseppe et al., 2020). In particular, children and adolescents with acute lymphoblastic 
leukemia treated with chemotherapy or who subsequently received a HST suffer from a wide 
range of neurocognitive deficits, although the evidence accumulated to date is inconclusive 
due to a lack of sufficient studies on the subject. In turn, at the bio-psychological level, patients 
diagnosed with acute lymphoblastic leukemia experience clinically significant levels of pain 
(Thompson et al., 2021), as well as high-risk psychological problems (suicidal ideation), 
which are exacerbated by the increased presence of somatic symptoms (pain, nausea, fatigue, 
and sleep problems) (Raghubar et al., 2022). This covariation between deficits in certain 
neurocognitive domains (executive functions) and patterns of somatic symptoms (e.g., chronic 
pain) increases the degree of disability in children and adolescents by negatively impacting 
their self-care and adaptive behaviors (Caes et al., 2021).  
 
Fortunately, new therapies are being researched and implemented in subgroups of 
patients whose diseases evolve with a relapsing clinical course or are resistant to the prescribed 
treatment. Specifically, chimeric antigen receptor T-cell (CAR-T) therapy is available and has 
been approved for use in children and adolescents with refractory or relapsed B-cell acute 
lymphoblastic leukemia (following a relapse after TPH, or after a second relapse). 
(Ragoonanan et al., 2022). Although scientific research to date provides data on its efficacy 
and effectiveness, very little research is available on its impact on mental health and 
neurocognition. This is despite its neurotoxic effects already described in the scientific 
literature (Ragoonanan et al., 2022), even though this cell therapy is generally safe at the 
neurological level (Ursu et al., 2022). In this regard, the only two scientific studies that have 
empirically addressed the potential cognitive impact of this therapy have been conducted 
exclusively in adult populations diagnosed with lymphoma and using self-reported 
measurement instruments. concluding that approximately 40% of patients report cognitive 
complaints, which persist for 1-5 years after CAR-T cell infusion and directly impact their 
quality of life, both physically and mentally (Kamal et al., 2021).  
 
However, its neurocognitive and psychological impact during critical or sensitive periods 
of neurodevelopment (i.e., childhood and adolescence); in other diseases such as 
lymphoblastic leukemia; and in comparison with other cell therapies (hematopoietic 
transplantation) has not yet been empirically examined. This subject of study is clinically 
relevant because children and adolescents face different stressors in relation to this new cell 
therapy, namely: the hematological-oncological disease they suffer from; uncertainty about 
receiving a novel and relatively recent medical treatment; and the specific neurotoxicity 
associated with these immunotherapies (whether subacute, due to delayed adverse events, the 
potential development of cytokine release syndrome, or immune effector cell-associated 
neurotoxicity syndrome [ICANS]) (Taylor et al., 2022). Therefore, prospective monitoring of 

 
 
 
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the neurocognitive functioning of patients receiving CAR-T cell therapies must be 
systematically and imperatively protocolized in routine clinical practice with this clinical 
population (Shalabi et al., 2021). This will also enable us to optimize its implementation and 
enhance the durability and consolidation of disease remission following administration of this 
new cell therapy, thereby stratifying subgroups of patients at higher potential risk of relapse 
(Shalabi et al.). 
 
Given that research into these new therapies has so far focused exclusively on the adult 
population, the scientific literature in this area of knowledge advocates a scientific-clinical 
approach characterized by a neurodevelopmental perspective, adapted to each stage of the 
patient's life cycle (Taylor et al., 2021). To this end, this research project proposes the 
following study: 
 
Given the potential complications and neuropsychological sequelae reported after 
exposure to such medical treatments, there is a striking scientific gap in relation to 
neurocognitive and psychological interventions for this population of children and adolescents 
with acute lymphoblastic leukemia exposed to different cell therapies, which is why this project 
pursue a randomized controlled clinical trial. However, unimodal interventions have proven to 
be very limited in terms of their transfer to other domains not directly trained (Slattery et al., 
2022), which is why this project includes several intervention modalities (cognitive training 
and mindfulness-based emotional regulation training) whose independent efficacy has only 
been partially tested in this clinical population, given the very few clinical trials conducted in 
this regard (Vekety et al., 2021). Specifically, with regard to cognitive training interventions, 
the only two randomized clinical trials implemented to date in children with acute 
lymphoblastic leukemia demonstrated efficacy in some neuropsychological domains (working 
memory and processing speed), with these results being maintained at the 6-month follow-up 
(Conklin et al., 2017). In turn, mindfulness-based interventions have been shown to be 
effective, through randomized controlled clinical trials, in improving quality of life and mental 
health in adult hematopoietic stem cell transplant recipients (Duong et al., 2017). However, 
these mindfulness-based interventions have not been tested in children and adolescents 
receiving hematopoietic transplantation or CAR-T therapy, despite being recommended in 
recent clinical practice guidelines for patients in this age group. (Pathrose et al., 2021). In 
addition to the gold standard measures for assessing the effectiveness of a non-pharmacological 
clinical trial (neurocognitive and biopsychological), the scientific literature emphasizes the 
prognostic and predictive value of incorporating biomarkers (Bai et al., 2022), as well as 
neurofunctional indicators (connectome), in order to identify new patterns of potential change, 
whether at the biochemical or neural connectivity level, following the implementation of 
cognitive training and mindfulness (Kennedy et al., 2022).  
 
    In short, there is a significant scientific gap regarding the neurocognitive and 
biopsychological impact of these CAR-T cell therapies in children and adolescents, as well as 
the efficacy and effectiveness of non-pharmacological interventions in these patients (Schagen 
et al., 2022); this is a subject that has not been studied to date by any other national or 
international research team. In turn, this project is part of an ongoing line of research, which 
began in April 2021, in children and adolescents who have undergone some type of transplant 
(solid organ or hematopoietic progenitor), with two projects funded to date, where the PI is 
the one presenting this new project; it also ties in with another project on neurocognitive 
training in childhood cancer survivors (PI: Dr. Antonio Pérez Martínez). These two projects 
in transplanted populations also involve the participation of patients and their families in the 
form of focus groups, in order to inform future interventions and healthcare protocols.  To 
date, preliminary results from these two related projects show that children and adolescents 

 
 
 
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exposed to transplantation have clinically relevant problems, both at the neurocognitive level 
(in terms of intellectual ability, processing speed, attention, memory, visuoconstructive 
ability, and various executive functions) and mental health (both internalizing and 
externalizing psychological disorders, as well as the intensity and interference of the pain 
experienced). These difficulties and deficits have gone unnoticed by their healthcare 
professionals, who have been treating them for years, and explain part of the resistance to 
adhering to prescribed treatments and clinical recommendations.   
 
For all the above reasons, this project will contribute to creating a pioneering line of 
research in this clinical population, both nationally and internationally, establishing itself as a 
new strategic scientific-translational line that guarantees a humanized and comprehensive 
healthcare approach, of a biopsychosocial nature, for these patients at a stage of great 
vulnerability in their neurodevelopment (Steineck et al., 2020; Taylor et al., 2022). 
 
 
 
 
 
 
 
 
 

 
 
 
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HYPOTHESES  
 
The following are the hypotheses predicted for the study: 
 
1. Statistically significant changes will be observed at the neurocognitive, biopsychological, 
and connectome levels after multimodal treatment (cognitive training and mindfulness) 
compared to the waiting list group. 
2. Statistically significant changes will be observed at the neurocognitive, biopsychological, 
and connectome levels between the two intervention sequences: 1st cognitive training and 2nd 
mindfulness versus 1st mindfulness and 2nd cognitive training. 
 
OBJECTIVES 
 
1. To analyze the efficacy of multimodal treatment (cognitive training and mindfulness-based 
emotional regulation intervention) compared to a control group on neurocognitive, 
biopsychological, biomarker, and connectome outcome variables. 
2. Compare the effectiveness of the two intervention sequences (1st cognitive training and 2nd 
mindfulness versus 1st mindfulness and 2nd cognitive training) on neurocognitive, 
biopsychological, biomarker, and connectome outcome variables. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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METHODS 
 
1. Study Design 3: In this single-center study (La Paz University Hospital), the pilot phase of a 
randomized, counterbalanced, crossover controlled clinical trial with a recycled waiting list will 
be conducted according to CONSORT standards. (Boutron et al., 2017).  
 
2. Participants: A total of 40 patients (20 patients initially in the clinical trial phase and 20 on 
the waiting list) between the ages of 8 and 18 will be recruited from the three clinical groups in 
Study 1, requiring compliance with inclusion criteria (having a computer, mobile phone, or tablet 
with an Internet connection) and exclusion criteria (CI < 80 in Matrices). These 40 patients will 
be recruited from the sample participating in Study 1 using a strategic/intentional non-random 
sampling technique. 
 
3. Outcome variables: In pre-/post-intervention phases, primary variables will be measured 
using performance tests: processing speed (SDMT); sustained visual attention (CPT-3); working 
memory, implicit, immediate/delayed auditory-verbal, visual-spatial, and intermodal [Clinical 
Memory Assessment (ECM)]; verbal fluency [Verbal Fluency Test (VFT)]; resistance to visual 
interference [Colors and Words Test (STROOP)]. Secondary variables in pre-/post-intervention 
phases are questionnaires measuring: executive functions [BRIEF-2, parent-completed version]; 
pain intensity and interference [BPI, self-reported by patient]; sleep quality [PROMIS and AIQ, 
self-reported by patient]; emotional and behavioral problems [BASC-3, parent and self-reported 
versions]; and mindfulness, trait level [Children and Adolescent Mindfulness Measure (CAMM)]; 
as well as biomarkers (inflammatory and immunological) and a neurofunctional analysis 
(connectome), using electroencephalogram (EEG) recordings. In the intermediate phase (3 
months after the start of treatment), the BASC-3 questionnaire will be administered. Finally, at 
the 6-month follow-up after the end of both interventions, the BRIEF-2, BASC-3, BPI, AIQ, and 
PROMIS questionnaires will be included. 
 
4. Procedure: Participants will be randomized into two subgroups, which will be equally 
randomized into one of the following two intervention implementation sequences, according to 
an intragroup Latin square equal weighting technique (AB/BA design). (Fontes-de-Gracia et al., 
2020): 1st sequence) Cognitive training (weeks 1-12) + Mindfulness-based emotional regulation 
(weeks 13-24); 2nd sequence) Mindfulness-based emotional regulation (weeks 1-12) + Cognitive 
training (weeks 13-24). This equal weighting technique will allow for systematic control of 
progressive error (order or period), without the need for a washout period between the two 
interventions, due to a potential residual or carry-over effect, as the treatments do not interfere 
with each other and are of a different nature (neurocognitive intervention versus emotional 
intervention). 
 
Each intervention will last 12 weekly sessions, with a total sequence of 24 weeks for both 
treatments. The group of participants on the waiting list (control group) will remain there until 
after the 24 sessions, at which point they will begin the same process described above for 
randomization into subgroups and sequences for implementation of the interventions. Each 
treatment sequence will have a total of 10 participants assigned to it, in two age-differentiated 
groups (8-12 versus 13-18 years old), with 5 participants per group. Given this small sample size 
per group, in order to facilitate smooth interaction among participants, one of the pre-intervention 
scores (Emotional Regulation Index, BRIEF-2) will be used as a blocking variable, in addition to 
age, artificially dichotomized according to a cutoff point (resulting in low and high values on that 
index), thus maximizing the control of extraneous intergroup variables. Consequently, four 
subgroups of patients will be created by combining the levels of two blocking variables: age (8-
12 versus 13-18 years) and Emotional Regulation Index score (low versus high values). 

 
 
 
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Subsequently, after assigning an anonymized code to each patient, using web-based 
randomization software, each treatment administration sequence (AB/BA) will be randomly 
assigned to each of the four patient subgroups. 
 
On the one hand, the cognitive training intervention will use the Sincrolab platform, which 
guarantees security and confidentiality and has been validated in clinical populations of children 
and adolescents (Medina et al., 2021). Four weekly sessions of 15 minutes each will be prescribed, 
training neurocognitive functions such as attention, memory, visuospatial skills, and executive 
functions. This platform provides regular reports on the use and fulfillment of objectives for each 
participant. In addition, once a week, online and also in the afternoon for 60 minutes, a group 
video call will be held with all participants to discuss difficulties and obstacles in using the 
platform, as well as to promote full adherence to the weekly usage guidelines. All these sessions 
will be moderated by the principal investigator of this project. In the event of less than 50% 
weekly adherence to the use of Sincrolab, the research team will make a weekly call to the 
participant and their legal guardians to encourage greater compliance. On the other hand, 
mindfulness-based emotional regulation interventions will be carried out in groups and online 
(video calls), following intervention protocols that have already been validated in children and 
adolescents in this online format (Pathrose et al., 2021). Each weekly session will last 60 minutes, 
with practice tasks prescribed for everyday contexts (four weekly tasks of 15 minutes each). To 
this end, a web repository will be used, with two versions differentiated by age range (children 
versus adolescents), from which material (comics and audio files for practicing mindfulness-
based exercises) will be extracted to put emotional regulation skills into practice independently 
at home. The two interventions in each treatment sequence have the same duration and weekly 
workload for independent work. Each intervention implementation sequence will be preceded by 
a pre-intervention assessment, followed by an intermediate assessment before the change in 
treatment administration sequence, and ending with a post-intervention assessment (the same as 
the pre-intervention assessment). The connectome will be measured both at rest and during an 
activity (the neurocognitive assessment tests themselves) carried out by technical staff from an 
external company. Both the neurocognitive assessment and the connectome assessment will be 
carried out individually and in person at the hospital facilities, one month before the start of each 
treatment sequence. Biomarkers will be extracted from routine control tests. Finally, the 
questionnaires (for patients and their legal guardians) will be completed via electronic links from 
the publishers that market them (BRIEF-2 and BASC-3), as well as REDCap (BPI, PROMIS, 
AIQ, and CAMM). 
 
5. Statistical analyses: The statistical analyses for this third study will be described jointly for 
the two established objectives. 
 
First, mixed 2x3 ANCOVAs will be used (intergroup factor, with two levels: experimental group 
versus control; and repeated measures factor, with three levels: pre-intervention, post-
intervention, and six months), controlling for confounding variables (time elapsed since 
completion of the last treatment received: chemotherapy, TPH, or CAR-T). However, in the event 
of non-compliance with statistical assumptions such as normality, non-parametric analog models 
will be used. In turn, latent growth curve models will be developed. 
 
As for the intergroup factor, Tukey's HSD parametric tests (for homoscedastic contrasts) and 
Games-Howell tests (for heteroscedastic contrasts) will be used to control the type I error rate per 
family of comparisons. Likewise, in the event of non-compliance with parametric assumptions 
such as normality, the Mann-Whitney U test will be used for pairwise comparisons, controlling 
the type I error rate with the Bonferroni correction. Regarding the intragroup factor, parametric 
pairwise contrasts will be performed using Tukey's WSD test (for spherical contrasts) and the 

 
 
 
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Roy-Bose test (for non-spherical contrasts); and non-parametric pairwise comparisons will be 
performed using the Wilcoxon test together with a Dunn-Sidak post hoc correction. 
 
In turn, these parametric hypothesis testing procedures will be complemented with effect size 
indices such as omega squared, as an omnibus index, and Cohen's d, as an index for pairwise 
comparisons.  
 
Conversely, where appropriate, for the intergroup factor, effect size indices for nonparametric 
tests such as Freeman's Theta, as an omnibus index, and Cliff's Delta, as an index for pairwise 
comparisons, will be used. On the other hand, for the intragroup factor, Kendall's W-type 
omnibus effect size indices will be applied, as well as the biserial correlation for dependent pair 
ranks in order to perform multiple comparisons. 
 
Finally, for the interactive term, the effect size index f will be chosen as an omnibus test, and 
Cohen's d indices for simple effects. 
 
Finally, multiple regression analyses will be performed to predict post-treatment and 6-month 
follow-up measures (neurocognitive and biopsychological), coding some measures from Study 1 
as predictors, such as: processing speed levels, sustained visual attention, verbal fluency, and 
resistance to visual interference. 
 
6. Limitations, biases, and contingency plan: given that participant loss is expected in any 
clinical trial, additional participants from the previous study will be recruited in such a scenario. 
The multi-method evaluation approach used (objective neurocognitive tests, questionnaires, 
biomarkers, and connectome) will avoid the common method bias (Podsakoff et al., 2012). 
Anticipating the temporary limitation on pre-/post-intervention assessment tasks as a potential 
risk to implementation, the age-differentiated treatment editions will be implemented partially 
simultaneously, with a one-month delay in the start of the intervention for each age group, using 
that month for the pre-intervention assessment of the other group.    
 
    This project will be carried out in accordance with the ethical principles of the Fortaleza 
Declaration of Helsinki (2013), strictly respecting confidentiality and the requirements of 
Spanish/European data protection regulations, as well as the provisions of the biomedical research 
law (Law 14/2007, of July 3); the informed consent of patients and their legal guardians will be 
required. 
 
    Finally, given that the objectives of these studies have not been scientifically addressed to date 
in the child and adolescent population receiving CAR-T therapies, this project will make a novel, 
original, and relevant contribution at the scientific-clinical level, and is in line with one of the 
strategic lines of our institution, IdiPAZ, and its core hospital, given that it coordinates the 
European Reference Network TransplantChild. 
 
 
 

 
 
 
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DATA MANAGEMENT PLAN 
 
The data management plan will include criteria for the handling and administration of scientific 
data following the FAIR principles (Findable, Accessible, Interoperable, and Reusable). 
 
TYPE OF DATA: The data obtained from study participants are clinical (neurocognitive and 
biopsychological) and laboratory parameters, excluding genetic data. These data may be collected 
directly from individuals who agree to participate in the project, through clinical and/or laboratory 
tests. Likewise, in some circumstances, existing data in their medical records may be used and 
accessed by healthcare personnel with the consent of each participant. All of the above 
information will be included in greater detail in the Data Management Plan that will be developed 
for the project before its start and prior to the collection of personal data. Patients will be assigned 
a unique identifier and will be stored anonymously. 
 
ACCESS PROCEDURE: The variables to be studied will be stored in a digital data collection 
notebook (REDCap), which will serve as a database protected by an authentication system using 
a user code and password, to which only project researchers will have access. This database will 
be hosted on the servers of La Paz University Hospital, which complies with security regulations 
in this area, adopting the appropriate security measures in terms of access and storage. No copies 
will be stored on personal computers. 
 
OWNERSHIP: Ownership of the personal data to be processed during the course of the project 
will belong to each of the patients who have provided such data, who will sign an informed 
consent form to participate in the project. The data controller will be La Paz University Hospital 
(HULP). The informed consent form will reflect this information, as well as the data to be 
processed, the purpose for which it is collected, the medium on which it will be stored, the storage 
period, and the measures that will be implemented to maintain its security. The informed consent 
form will be drawn up in accordance with current regulations regarding the guarantee of 
participants' rights. 
 
RESPONSIBILITIES AND ROLES: The PI will be responsible for supervising the data 
generated by the group during the project and the data management plan. 
 
REPOSITORY: The data used, both intermediate and final, will be uploaded to the most 
appropriate repositories according to their type. A suitable repository is considered to be a Trusted 
Digital Repository (TDR), understood as one whose mission is to “provide reliable long-term 
access to managed digital resources to a designated community, now and in the future” (Research 
Libraries Group, 2002). The chosen repository must follow the OASIS reference model, 
developed by the Consultative Committee for Space Data Systems, whose purpose is to generate 
a standard for the long-term preservation of data that could be used by any organization, 
regardless of the nature of the information to be preserved. The current version of this model is 
covered by ISO 14721:2012. Thus, these data, as well as the publications derived from the 
development of the project, will be published, among others, in the Institutional REPository of 
SALUD of the Carlos III Health Institute (REPISALUD, https://repisalud.isciii.es/), and in the 
Institutional Repository of the Regional Ministry of Health of the Community of Madrid 
(https://repositoriosaludmadrid.es). 
 
Access for other researchers who may be legitimately interested will in any case be subject to 
approval, complying with the requirement of open access in a restricted environment in 
accordance with the nature of personal data. 

 
 
 
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SPECIFIC ETHICAL OR LEGAL REQUIREMENTS APPLICABLE: The data used for 
the development of this project will be processed in accordance with the provisions of current 
legislation: Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital 
Rights and Regulation (EU) 2016/679 of the European Parliament and of the Council on the 
protection of natural persons with regard to the processing of personal data and on the free 
movement of such data. It will also obtain the favorable opinion of a research ethics committee. 
The provisions of Law 14/2007, of July 3, on Biomedical Research, will also apply. 
 
INTELLECTUAL PROPERTY: The results of the project that may lead to new diagnostic 
techniques, modifications to existing treatments and/or protocols, medicines, medical devices, or 
vaccines will initially be communicated confidentially to the institution by the PI in order to 
determine whether they could be patentable or should be protected by intellectual property rights. 
The data may not be disclosed until the patents related to the research are protected, if any, or the 
appropriate measures are taken to protect the intangible assets. 
 
 

 
 
 
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WORK PLAN 
 
The research team formally involved in this project consists of: 
-Psychologists trained in neuropsychology to perform neurocognitive and biopsychological 
assessments and interpret their data: Eduardo Fernández Jiménez (EFJ) and Cristina Campoy 
Lacasa (CCL) 
-Hematologists/oncologists to refer participants to the project, record biomarkers, and medically 
interpret the results: Víctor Galán Gómez (VGG), David Bueno Sánchez (DBS), Víctor Quintero 
Calcaño (VMQC), Mª Isabel Benítez Carabante (MIBC), and María Trabazo del Castillo 
(MTdC).  
-Teaching and research staff: Mª Fe Bravo Ortiz (MFBO), expert in psychotherapeutic 
interventions; Rocío de la Vega de Carranza (RdlVdC), national reference for pain in children 
and adolescents and telemedicine; and Alejandro Alberca González (AAG), expert in health 
technologies.  
-Formal collaboration of a representative of the Spanish Association Against Cancer (citizen 
participation): María Eugenia Bustelo Almeida (MEBA), to identify unmet needs during the care 
process. 
-Additional citizen participation (non-formal collaborators) from ASION: Virginia Martínez 
García (VMG) and Alicia Moraleda Sánchez (AMS); to identify unmet needs during the care 
process. 
  
PROJECT DEVELOPMENT STAGES 
 
-November-December 2025 (experimental group) and July-August 2026 (recycled waiting 
list): Pre-intervention neurocognitive, biopsychological (conducted by psychologists), and 
connectome (conducted by an external company) assessment. 
-March 2026-July 2026 (experimental group) and September 2026-February 2027 (recycled 
waiting list): Cognitive training and mindfulness. 
-July-August 2026 (experimental group) and March-April 2027 (recycled waiting list): Post-
intervention neurocognitive, biopsychological, and connectome assessment. 
-December 2026 (experimental group) and August 2027 (recycled waiting list): Bio-
psychological assessment at 6 months follow-up. 
-November-December 2027: Data extraction, database completion, data analysis, and 
scientific dissemination (preparation of the fourth article for a JCR specialized journal and 
conferences). 
-November-December 2027: Dissemination of results through associations and the media.   
 
 
 

 
 
 
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IMPLEMENTATION 
RISKS, 
CONTROL 
PLANNING, 
AND 
CONTINGENCY PLAN 
 
1) Delay in commencement due to lack of approval from the Ethics Committee: said approval 
will be processed after publication of the provisional resolution granting this call for proposals.  
2) Personnel risks: in the event of a potential drop in the participation of collaborators, a 
researcher with a similar profile will be added to the team to carry out those tasks.  
3) Time risks: the interim monitoring report will assess the degree of project implementation in 
accordance with the initial planning. In the event of a delay, an extension of the project similar 
to the length of the delay will be requested, which will not exceed the maximum allowed.  
4) Economic-administrative implementation risks: an initial meeting will be held with the 
institution's public project managers to determine the expenses to be processed in accordance 
with the Public Sector Contracts Law and to plan their management, with coordination and 
follow-up meetings being held with these managers. Finally, it is stated that the execution of the 
project is feasible with the current design and methodology, that the probability of the identified 
risks is low, and that their impact is moderate. A checklist of potential risks has been designed 
and these will be monitored every six months, in addition to an interim scientific and execution 
evaluation (including a risk assessment) and a final evaluation of the project. 
 
 

 
 
 
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AVAILABLE RESOURCES / PROJECT FEASIBILITY 
 
In order to carry out the three studies that make up this project in a feasible and efficient manner, 
the following resources are already available, as detailed below. 
   
HUMAN RESOURCES 
 
The Child and Adolescent Mental Health Unit, to which the principal investigator of this project 
is attached, implements therapeutic interventions, either in person or online, with these patients 
as part of its structural care activity. Therefore, the interventions that make up this study will be 
feasible as they are incorporated into our usual clinical practice. 
  
    In turn, La Paz University Hospital and the two research groups with which the PI of this 
project collaborates systematically promote the completion of doctoral theses within the 
framework of projects already in progress, ensuring a constructive learning environment and 
constant supervision for the effective acquisition of scientific skills by potential doctoral students, 
as has been done to date with doctoral theses and master's theses under the direction of this PI. 
Consequently, the active participation of residents in this project who are undergoing their 
Specialized Health Training in the hospital's Pediatric Hemato-Oncology or Psychiatry, Clinical 
Psychology, and Mental Health services will be encouraged, so that they can develop their 
doctoral thesis with the results derived from the project.  
 
MATERIAL RESOURCES 
 
The Child and Adolescent Mental Health Unit at La Paz University Hospital has numerous offices 
(eight available in the afternoon and three in the morning) equipped with computers with internet 
connection, telephones, webcams, and microphones to contact participants by phone, carry out 
thematic interventions, and conduct all face-to-face assessments.