RECRUITINGINTERVENTIONAL

Feasibility/Acceptability of Attentional-Control Training in Survivors

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

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.

OTHER

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.

Locations (1)

Children's National Hospital

Washington D.C., District of Columbia, United States