Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
Recruiting · NCT05099874 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's National Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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.
Where it is running
1 location listed across 1 US state.
- Children's National Hospital - Washington D.C., District of Columbia, United States