Recruiting

Attentional-Control Training

Sponsor:

Children's National Research Institute

Code:

NCT05528939

Conditions

Pediatric Cancer

Pediatric ALL

Pediatric Brain Tumor

Attention Difficulties

Cognitive Deficit in Attention

Eligibility Criteria

Sex: All

Age: 8 - 16

Healthy Volunteers: Not accepted

Interventions

EndeavorRx

Control video game

Study Details

Brief 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.

Conditions

Pediatric Cancer

Pediatric ALL

Pediatric Brain Tumor

Attention Difficulties

Cognitive Deficit in Attention

Study ID

NCT05528939

Start date

Jun 14, 2023

Status verified date

Jan, 2025

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 16

Healthy Volunteers: Not accepted

Inclusion 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 ≥ 75th percentile on the CPT-3 Omission Errors scale or on the BRIEF-2 Cognitive Regulation Index will be randomized.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EndeavorRx

Children will be asked to begin digital attentional control training at home within 6 weeks of baseline testing and to complete 6 training missions per day (25-30 minutes), 5 days per week, for 4 weeks (total = 120 training missions).

active comparator: Control

An active control program designed to replicate aspects of the intervention (e.g., regular use of digital device to access fun educational activities) while engaging cognitive skills not particularly involving attention.

Interventions

EndeavorRx

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.

Control 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.

Primary outcome measure

  • Feasibility assessed by patient/family interest [ Time Frame: Baseline ]
  • Feasibility assessed by EndeavorRx training adherence rates [ Time Frame: After completion of 4 weeks of EndeavorRx training ]
  • Feasibility assessed by reports of technical ease-of-use and satisfaction [ Time Frame: End of training (+4 weeks) ]

Central Contacts and Locations

Central contacts

Locations

Children's National Hospital

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

More Information

Sponsor

Children's National Research Institute

Last update posted

Jan 10, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2025-01-10.