NCT05099874 Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
| NCT ID | NCT05099874 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's National Research Institute |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-12-20 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-12-20 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Steven J Hardy, Ph.D.
PRINCIPAL INVESTIGATOR
Children's National Research Institute
Frequently Asked Questions
Who can join the NCT05099874 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 16 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05099874 currently recruiting?
Yes, NCT05099874 is actively recruiting participants. Contact the research team at sjhardy@childrensnational.org for enrollment information.
Where is the NCT05099874 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT05099874 clinical trial?
NCT05099874 is sponsored by Children's National Research Institute. The principal investigator is Steven J Hardy, Ph.D. at Children's National Research Institute. The trial plans to enroll 20 participants.
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