RecruitingNot ApplicableNCT05528939

Feasibility/Acceptability of Attentional-Control Training in Survivors

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

Sponsor

Children's National Research Institute

Enrollment

50 participants

Start Date

Jun 14, 2023

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 8 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a computerized brain training program designed to improve attention and focus in children and teenagers who survived leukemia or brain tumors and are now experiencing attention difficulties as a late effect of their cancer treatment. **You may be eligible if...** - Your child is 8–16 years old - Your child has a history of acute lymphoblastic leukemia (ALL) or a brain tumor - It has been at least 1 year since your child finished their planned cancer treatment, and they are in stable remission - Your child shows attention difficulties based on standardized testing - Your child is either not taking stimulant medication for attention, or has been on a stable dose for at least 30 days - Your child and you can both participate in English **You may NOT be eligible if...** - Your child has a history of light-triggered seizures (photosensitive epilepsy) - Your child has a motor, vision, or hearing disability that prevents computer use - Your child has a mental health condition that would take priority over this training - Your child's estimated IQ is below 80 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndeavorRx

EndeavorRx is a digital intervention delivered through an action video game that is indicated to improve attention function. EndeavorRx users first complete two discrete tasks: 1) a perceptual discrimination/attention task in which users respond to target stimuli and ignore distractor stimuli (e.g., tapping the screen quickly only when red aliens appear) and 2) a sensorimotor navigation task in which users tilt their device to steer a hovercraft down a river while targeting or avoiding certain objects. Users are subsequently presented with a multitask training session where they complete the perceptual discrimination/attention task and the sensorimotor navigation task simultaneously. Algorithms adapt the program in both real-time and between sessions to automatically adjust the difficulty level.

OTHERControl video game

The active control program, used in previous studies of this intervention, was designed to match EndeavorRx on expectancy, engagement, and time on task in the form of a challenging and engaging digital word game, targeting cognitive domains not targeted by EndeavorRx and not primarily associated with attentional difficulties. Users are instructed to find and connect letters on a grid to spell words; points are awarded based on number of words formed, word length, and the use of unusual letters. There is progression in difficulty to maintain engagement and expectation of benefit from patients and their caregivers.