Sickle Cell DiseaseACTNCT05099874
Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
A study testing EndeavorRx in people with Sickle Cell Disease and Attention Deficit, run by Children's National Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Sickle Cell Disease, Attention Deficit, Cognitive Deficit in Attention
- What is being tested?
- EndeavorRx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Steven Hardy, PhD, 202-476-5000, sjhardy@childrensnational.org
About this study
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.
Read the 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.
- Being tested
- EndeavorRx
- Medical subject headings
- Anemia, Sickle Cell, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndeavorRxDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: EndeavorRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%).
Measured: 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.
Measured: 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)
EndeavorRx efficacy will be evaluated by examining change in Omission Errors on the CPT-3 computerized assessment after completing EndeavorRx.
Measured: 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)
EndeavorRx efficacy will be evaluated by examining change in the Inattention subscale of the parent-reported ADHD-RS-V after completing EndeavorRx.
Measured: Approximately 4 weeks from start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start20 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven J. Hardy, Children's National Research Institute
- Investigators
- Steven J Hardy, Ph.D., Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099874
- Sponsor's protocol ID
- Pro00016536
- Acronym
- ACT
- Status last verified
- Jan 2025
- First submitted
- 19 Oct 2021
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of Attentional-Control Training in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05099874
- Acronym / sponsor ID
- ACT / Pro00016536
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndeavorRx | Experimental | Device: EndeavorRxChildren 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). |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndeavorRxEndeavorRx 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. | Device | EndeavorRx |
Primary outcome
EndeavorRx feasibility assessed by patient/family interest
Time frame: 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
Time frame: 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
Time frame: Approximately 4 weeks from start of intervention
Feasibility will be determined by examining parent and child reports of technical ease-of-use and satisfaction.
2 secondary outcomes
Inattention assessed by change in Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3)
Time frame: 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)
Time frame: Approximately 4 weeks from start of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven J Hardy, Ph.D. principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndeavorRx in people with Sickle Cell Disease and Attention Deficit, run by Children's National Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven J Hardy, Ph.D. (202-476-5000, sjhardy@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EndeavorRx feasibility assessed by patient/family interest (time frame: Approximately 10 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.