RecruitingNot ApplicableNCT05099874

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


Sponsor

Children's National Research Institute

Enrollment

20 participants

Start Date

Dec 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 8 YearsMax Age: 16 Years

Inclusion Criteria4

  • 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 Criteria5

  • 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.

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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.


Locations(1)

Children's National Hospital

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

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NCT05099874


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