Training program to improve attention in children with sickle cell disease
Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
This study is testing a fun, game-like training program to see if it can help children with sickle cell disease improve their attention and thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 8 Years to 16 Years |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT05099874 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility and preliminary efficacy of EndeavorRx, an FDA-approved electronic attentional-control training program, for children aged 8-16 with sickle cell disease (SCD). Participants will engage with the program for 25-30 minutes daily, five days a week, over four weeks, in a game-like environment that adapts to their performance. The study aims to assess improvements in attention and cognitive functioning, which are often impaired in children with SCD due to cerebral infarcts. The intervention is designed to help mitigate the cognitive deficits associated with SCD and improve overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-16 diagnosed with sickle cell disease who have been on monthly blood transfusions for at least three months and exhibit significant attention deficits.
Not a fit: Patients with an estimated IQ below 70, significant motor or sensory impairments, or pre-existing mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance cognitive functioning and attention in children with sickle cell disease, leading to better academic and life outcomes.
How similar studies have performed: Previous studies have shown positive effects of EndeavorRx in youth with ADHD, suggesting potential for success in similar cognitive deficits in SCD.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington D.C., District of Columbia
- Children's National Hospital — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Steven J Hardy, Ph.D. — Children's National Research Institute
- Study coordinator: Steven J Hardy, Ph.D.
- Email: sjhardy@childrensnational.org
- Phone: 202-476-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.