Clinical trial NCT05099874: Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
Official title: Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Attention Deficit
Cognitive Deficit in Attention
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Children with sickle cell disease (SCD) exhibit significantly reduced cognitive functioning compared to peers and siblings without SCD. Cognitive deficits are greatest among those with severe SCD genotypes, persistent anemia, and strokes and these deficits worsen over time. These deficits often manifest as difficulties with executive functioning and attention due to the predominance of cerebral infarcts (\>90%) that occur in the frontal cortex. Reduced capacity to engage such cognitive skills has significant real-world implications, leading to disruption to academic achievement and attainment, vocational outcomes, and quality of life. 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. Data support effects of EndeavorRx on performance-based and parent-reported measures of attention in youth with Attention-Deficit/Hyperactivity Disorder (ADHD). Given the similarities in attentional functioning among youth with ADHD and those with SCD, EndeavorRx holds promise as an intervention for patients experiencing SCD-related cognitive deficits. 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 due to an identified high risk of stroke or as a preventive measure to protect against additional stroke events.

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.

Primary outcomes:
measure: EndeavorRx feasibility assessed by patient/family interest
timeFrame: Approximately 10 months
measure: EndeavorRx feasibility assessed by program completion rates
timeFrame: Approximately 4 weeks per participant
measure: EndeavorRx feasibility assessed by reports of technical ease-of-use and satisfaction
timeFrame: Approximately 4 weeks from start of intervention
Secondary outcomes:
measure: Inattention assessed by change in Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3)
timeFrame: Approximately 4 weeks from start of intervention
measure: Inattention assessed by change in the Inattention subscale of the ADHD Rating Scale, Fifth Edition (ADHD-RS-V)
timeFrame: Approximately 4 weeks from start of intervention
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Steven J Hardy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: