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

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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.

Conditions:

Sickle Cell Disease Attention Deficit Cognitive Deficit in Attention

Study Start (Actual) 2022-12-20

Primary Completion (Estimated) 2023-12

Study Completion (Estimated) 2023-12

Enrollment (Estimated) 20

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 Washington, District of Columbia, United States

Eligibility Criteria

Description

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.

Ages Eligible for Study: 8 Years to 16 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2021-10-19
First Submitted that Met QC Criteria2021-10-19
First Posted2021-10-29

Study Record Updates

Last Update Submitted that Met QC Criteria2023-06-23
Last Update Posted2023-06-26
Last Verified2023-06