Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-16
SponsorChildren's National Research Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
EndeavorRx
DeviceEndeavorRx 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: EndeavorRxExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Approximately 10 months2
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%).
Time frame
Approximately 4 weeks per participant3
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.
Time frame
Approximately 4 weeks from start of interventionSecondary outcomes
1
Inattention assessed by change in Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3)
EndeavorRx efficacy will be evaluated by examining change in Omission Errors on the CPT-3 computerized assessment after completing EndeavorRx.
Time frame
Approximately 4 weeks from start of intervention2
Inattention assessed by change in the Inattention subscale of the ADHD Rating Scale, Fifth Edition (ADHD-RS-V)
EndeavorRx efficacy will be evaluated by examining change in the Inattention subscale of the parent-reported ADHD-RS-V after completing EndeavorRx.
Time frame
Approximately 4 weeks from start of interventionSponsors and contacts
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Source ClinicalTrials.gov