Feasibility/Acceptability of Attentional-Control Training in Survivors

Description

This is a multicenter pilot randomized controlled trial, with an active control condition, of the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a cohort of survivors of acute lymphoblastic leukemia or brain tumor ages 8-16 who are \> 1 year from the end of therapy.

Conditions

Pediatric Cancer, Pediatric ALL, Pediatric Brain Tumor, Attention Difficulties, Cognitive Deficit in Attention

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Study Overview

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Study Details

Study overview

This is a multicenter pilot randomized controlled trial, with an active control condition, of the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a cohort of survivors of acute lymphoblastic leukemia or brain tumor ages 8-16 who are \> 1 year from the end of therapy.

FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors

Feasibility/Acceptability of Attentional-Control Training in Survivors

Condition
Pediatric Cancer
Intervention / Treatment

-

Contacts and Locations

Washington

Children's National Hospital, Washington, District of Columbia, United States, 20010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Aged 8-16 years at time of screening.
  • * History of diagnosis of acute lymphoblastic leukemia (ALL) or brain tumor (BT).
  • * At least 1 year from completion of planned therapy and stable from a disease standpoint.
  • * Participating child and caregiver are fluent in spoken English.
  • * Availability of a caregiver who is willing and capable of providing support and supervision during cognitive training.
  • * Participating child is either not taking any prescribed stimulant medication for attention difficulties or has been prescribed a stable dose of stimulant medication for attention difficulties for at least 30 days prior to enrollment.
  • * Only patients with a T-score \> 57 (i.e., ≥75th percentile) for Omission Errors on the CPT-3 will be randomized.
  • * A history of photosensitive seizures.
  • * A motor, visual, or auditory handicap that prevents computer use.
  • * A mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training.
  • * Participants identified during the baseline assessment as having a full-scale IQ \< 80, as estimated by WASI-II (Vocabulary and Matrix Reasoning), will not be randomized.

Ages Eligible for Study

8 Years to 16 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's National Research Institute,

Steven Hardy, Ph.D., PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

2025-08-31