Recruiting

Attentional-Control Training

Sponsor:

Children's National Research Institute

Code:

NCT05099874

Conditions

Sickle Cell Disease

Attention Deficit

Cognitive Deficit in Attention

Eligibility Criteria

Sex: All

Age: 8 - 16

Healthy Volunteers: Not accepted

Interventions

EndeavorRx

Study Details

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.

Conditions

Sickle Cell Disease

Attention Deficit

Cognitive Deficit in Attention

Study ID

NCT05099874

Start date

Dec 20, 2022

Status verified date

Jan, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 16

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

EndeavorRx

EndeavorRx is a digital intervention delivered through an action video game that is indicated to improve attention function. EndeavorRx users first complete two discrete tasks: 1) a perceptual discrimination/attention task in which users respond to target stimuli and ignore distractor stimuli (e.g., tapping the screen quickly only when red aliens appear) and 2) a sensorimotor navigation task in which users tilt their device to steer a hovercraft down a river while targeting or avoiding certain objects. Users are subsequently presented with a multitask training session where they complete the perceptual discrimination/attention task and the sensorimotor navigation task simultaneously. Algorithms adapt the program in both real-time and between sessions to automatically adjust the difficulty level.

Primary outcome measure

  • EndeavorRx feasibility assessed by patient/family interest [ Time Frame: Approximately 10 months ]
  • EndeavorRx feasibility assessed by program completion rates [ Time Frame: Approximately 4 weeks per participant ]
  • EndeavorRx feasibility assessed by reports of technical ease-of-use and satisfaction [ Time Frame: Approximately 4 weeks from start of intervention ]

Central Contacts and Locations

Central contacts

Steven J Hardy, Ph.D.

202-476-5000sjhardy@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Steven Hardy, PhD

202-476-5000sjhardy@childrensnational.org

More Information

Sponsor

Children's National Research Institute

Last update posted

Jan 10, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2025-01-10.