At-home cognitive training and mindfulness for children after CAR-T, transplant, or chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center randomized trial delivers a multimodal, telematic psychological intervention that pairs digital cognitive training with a pediatric-adapted mindfulness-based emotional regulation program. Participants are randomized to immediate intervention or a waitlist control, and those in the intervention arm receive the two components in counterbalanced order (cognitive training then mindfulness, or mindfulness then cognitive training). Outcomes include standardized neurocognitive tests, parent- and self-report measures of emotional and executive functioning, and EEG-based measures of functional brain connectivity measured at baseline, post-intervention, and 6-month follow-up. Most intervention sessions are remote, while cognitive testing and EEG recordings are performed in person at the recruiting center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of acute B-cell lymphoblastic leukemia.
* Previous treatment with CAR-T therapy, chemotherapy, and/or hematopoietic stem cell transplantation.
* Age between 8 and 18 years.
* Native Spanish speaker or high proficiency in Spanish sufficient to understand study procedures and complete assessment instruments.
* Access to a computer, tablet, or smartphone with an Internet connection.

Exclusion Criteria:

* Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury.
* Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.

Where it's running

• Hospital Universitario La Paz
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Eduardo Fernandez Jimenes, Phd
• Email: eduferjim.psyc@gmail.com
• Phone: +34917277417

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.