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

Conditions

• Attention Deficit
• Cognitive Deficit in Attention
• Sickle Cell Disease

Eligibility Criteria

Sex

ALL

Age

8 Years - 16 Years

Healthy Volunteers

Not accepted

Interventions

• EndeavorRx — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Dec 20, 2022

Status verified

Jan 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: EndeavorRx
  Children will be asked to begin attentional control training at home within two 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).

Primary Outcome Measure

EndeavorRx feasibility assessed by patient/family interest [ Time Frame: Approximately 10 months ]

Central Contacts

• Steven J Hardy, Ph.D.
  202-476-5000
  [email protected]

Locations (1)

Find similar trials in Washington D.C., DC

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