Attention Deficit, Cognitive Deficit in Attention, Sickle Cell Disease
Conditions
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.
Interventions
DEVICEEndeavorRx
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.
Sponsors
Children's National Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EndeavorRx feasibility assessed by patient/family interest | Approximately 10 months | Feasibility will be determined by examining the proportion of eligible patients/families approached about the study who enroll. |
| EndeavorRx feasibility assessed by program completion rates | Approximately 4 weeks per participant | Feasibility will be evaluated by examining the proportion of the sample that completes at least 60 EndeavorRx missions (50%). |
| EndeavorRx feasibility assessed by reports of technical ease-of-use and satisfaction | Approximately 4 weeks from start of intervention | Feasibility will be determined by examining parent and child reports of technical ease-of-use and satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inattention assessed by change in Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) | Approximately 4 weeks from start of intervention | EndeavorRx efficacy will be evaluated by examining change in Omission Errors on the CPT-3 computerized assessment after completing EndeavorRx. |
| 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 | EndeavorRx efficacy will be evaluated by examining change in the Inattention subscale of the parent-reported ADHD-RS-V after completing EndeavorRx. |
Countries
United States
Contacts
Primary ContactSteven J Hardy, Ph.D.
Outcome results
None listed