Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 16
Healthy Volunteers: f
View:

• 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).

Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Steven J Hardy, Ph.D.
sjhardy@childrensnational.org
202-476-5000
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
Experimental: EndeavorRx
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).
Sponsors
Leads: Children's National Research Institute

This content was sourced from clinicaltrials.gov