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

NCT05099874 | Recruiting FDA Device

• 1 other identifier: Pro00016536
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• EndeavorRx feasibility assessed by patient/family interest

  Feasibility will be determined by examining the proportion of eligible patients/families approached about the study who enroll.

  Approximately 10 months

• EndeavorRx feasibility assessed by program completion rates

  Feasibility will be evaluated by examining the proportion of the sample that completes at least 60 EndeavorRx missions (50%).

  Approximately 4 weeks per participant

• EndeavorRx feasibility assessed by reports of technical ease-of-use and satisfaction

  Feasibility will be determined by examining parent and child reports of technical ease-of-use and satisfaction.

  Approximately 4 weeks from start of intervention

Secondary Outcomes (2)

• Inattention assessed by change in Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3)

  Approximately 4 weeks from start of intervention

• Inattention assessed by change in the Inattention subscale of the ADHD Rating Scale, Fifth Edition (ADHD-RS-V)

  Approximately 4 weeks from start of intervention

Study Arms (1)

EndeavorRx

EXPERIMENTAL

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).

Device: EndeavorRx

Interventions

EndeavorRx DEVICE

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.

EndeavorRx

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Steven J Hardy, Ph.D.

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven J Hardy, Ph.D.

CONTACT

202-476-5000; sjhardy@childrensnational.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: December 20, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)