NCT05099874Recruiting
Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 19 Oct 2021
- Start date
- 20 Dec 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Children's National Research Institute
- Diseases
- Sickle cell disease
- NCT number
- NCT05099874
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 20 Dec 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- estimated Intelligence Quotient \< 70
- insufficient English fluency.
Who the study is looking for
- 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).
Age in the registry: 8 years to 16 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.