RECRUITINGINTERVENTIONAL

Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease

About This Trial

Children with sickle cell disease (SCD) exhibit significantly reduced cognitive functioning (often difficulties with attention) compared to peers and siblings without SCD. EndeavorRx (Akili Interactive Labs: Boston, MA) is an FDA-approved home-based, electronic attentional-control training program designed to treat attention problems in youth. Users access EndeavorRx on a tablet device for 25-30 minutes each day, 5 days per week, for 4 weeks. The program involves training in a game-like environment that repeatedly challenges attentional-control abilities and adapts to user performance, becoming more difficult over time as performance improves. This pilot study is examining the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a sample of 20 children with SCD ages 8-16 who are being treated with chronic blood transfusion therapy.

Who May Be Eligible (Plain English)

Who May Qualify: - diagnosis of SCD - ages 8-16 years - maintained on monthly blood transfusions consistently for at least 3 months. - patients will be proceed to the intervention phase only if they have a T-score \> 75th percentile for Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) or a T-score \> 75th percentile for the Inattention subscale of the ADHD Rating Scale, Fifth Edition (ADHD-RS-V). Who Should NOT Join This Trial: - estimated Intelligence Quotient \< 70 - motor, visual, or auditory impairment that prevents computer use - known diagnosis of a mental health condition that precludes, or takes treatment precedence over, participation in cognitive training - history of photosensitive seizures - insufficient English fluency. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * diagnosis of SCD * ages 8-16 years * maintained on monthly blood transfusions consistently for at least 3 months. * patients will be proceed to the intervention phase only if they have a T-score \> 75th percentile for Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) or a T-score \> 75th percentile for the Inattention subscale of the ADHD Rating Scale, Fifth Edition (ADHD-RS-V). Exclusion Criteria: * estimated Intelligence Quotient \< 70 * motor, visual, or auditory impairment that prevents computer use * known diagnosis of a mental health condition that precludes, or takes treatment precedence over, participation in cognitive training * history of photosensitive seizures * insufficient English fluency.

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.

Locations (1)

Children's National Hospital

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