Attentional-Control Training for Sickle Cell Disease (ACT Trial)

Recruiting in Palo Alto (17 mi)

Overseen BySteven J Hardy, Ph.D.

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's National Research Institute

No Placebo Group

Approved in 1 jurisdiction

Trial Summary

What is the purpose of 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.

Eligibility Criteria

This trial is for children aged 8-16 with Sickle Cell Disease (SCD) who are on monthly blood transfusions. They must show attention difficulties, evidenced by specific scores on the Conners' CPT-3 or ADHD-RS-V tests.

Participant Groups

The study tests EndeavorRx, an FDA-approved electronic program designed to improve attention in kids. Participants use it at home for about half an hour daily over four weeks, and its difficulty increases as their performance improves.

1Treatment groups

Experimental Treatment

Group I: EndeavorRxExperimental Treatment1 Intervention

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).

EndeavorRx is already approved in United States for the following indications:

🇺🇸 Approved in United States as EndeavorRx for:

Improving attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.