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临床试验/NCT05099874
NCT05099874招募中不适用

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

Children's National Research Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
EndeavorRx feasibility assessed by patient/family interest

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

EndeavorRx feasibility assessed by patient/family interest

时间窗: 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 reports of technical ease-of-use and satisfaction

时间窗: Approximately 4 weeks from start of intervention

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

EndeavorRx feasibility assessed by program completion rates

时间窗: Approximately 4 weeks per participant

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

次要结局

  • 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)

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven J. Hardy

Associate Professor of Psychiatry and Behavioral Sciences

Children's National Research Institute

研究点 (2)

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