A Randomized, Double-blind, Parallel-group, Exploratory Clinical Trial to Evaluate Executive Function and Cognitive Improvement After Intervention Utilizing a Computerized Cognitive Rehabilitation Program (D-kit/EF1) in Children With Borderline Intellectual Functioning or Mild Intellectual Disability (FSIQ 50 - 85)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in NIHTB-CB DCCS Computed Score from Baseline to Week 12
研究概览
简要总结
The goal of this exploratory clinical trial is to test the effects of the computerized cognitive rehabilitation program (D-kit/EF1) for children with borderline intellectual functioning or mild intellectual disability after its use.
Participants will use the D-kit/EF1 program on an iOS device 5 times a week for 30 minutes each session, for a duration of 12 weeks.
Researchers will compare treatment group that uses D-kit/EF1 with sham group that watches educational videos on the same iOS device.
详细描述
This clinical trial is a randomized, double-blind, parallel-group, exploratory study to confirm the efficacy of a computerized cognitive rehabilitation program (D-kit/EF1) in cognitive improvement of children with borderline intellectual functioning or mild intellectual disability (FSIQ 50 - 85).
D-kit/EF1, a computerized cognitive rehabilitation program, incorporates game-type quizzes to enhance executive function in children with Mild Intellectual Disability (MID) or Borderline Intellectual Functioning (BIF) as an adjunctive treatment alongside the current standard of care (SOC). D-kit/EF1 delivers interventions through online platforms and can be downloaded to smart devices through the iOS App store or Google Play Store. Games are specifically designed to assist children with delayed cognitive development in the acquisition of foundational cognitive skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
This clinical trial is conducted using a double-blind design, requiring both the evaluators and participants to maintain blindness. The randomization table is prepared by an independent statistician who seals each copy of the randomization table separately after the allocation of the investigational device and control device.
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-8 years (48-96 months) of both genders at the time of obtaining consent.
- •Children with borderline intellectual functioning or mild intellectual disability (FSIQ 50-85) who meet the following criteria within 3 months of screening:
- •Stanford-Binet Intelligence Scale - 5th edition (SB-5) criteria: FSIQ 50-
- •NIH Toolbox Cognition Battery (NIHTB-CB) DCCS score of 7 or lower.
- •Children who are capable of communicating and behaving at a level sufficient to participate in the required tests and therapeutic activities of this clinical trial.
- •Individuals for whom the legal guardian and primary caregiver have voluntarily decided to participate in this clinical trial after receiving sufficient explanation and have provided written consent to comply with the requirements of the clinical trial.
排除标准
- •If the parents or primary caregiver of the trial subjects, who will perform the key assessments on the trial subjects, are unable to read or write in English, thus are impossible to conduct the assessments.
- •Patients with conditions (e.g., blindness, color blindness, hearing loss, or deafness) that make it difficult to perform the digital therapy of the medical device for the clinical trial, D-kit/EF1, and the key assessment item for the clinical trial, NIHTB-CB DCCS test.
- •If the subject has participated in another clinical trial or has been administered investigational drugs for clinical trial purposes within the 4 weeks prior to screening (except, cases where the subject has not received investigational drugs or has participated in non-interventional observational studies are eligible for enrollment).
- •Other subjects who are deemed unsuitable for participation in this clinical trial based on the judgment of the investigators.
结局指标
主要结局
Change in NIHTB-CB DCCS Computed Score from Baseline to Week 12
时间窗: Baseline (Week 0), Post-treatment (Week 12)
DCCS is assessed to evaluate the subjects' executive function and cognitive function. Two target pictures that differ across two dimensions are presented to the participants. Participants are asked to match a series of bivalent test pictures to target pictures, first according to one dimension, and after a number of trials, according to the other dimension. "Switch" trials are also employed, in which the participants must change the dimension. Scoring is based on a combination of accuracy and reaction time. A 2-vector scoring method is employed that uses accuracy and reaction time, where each of these "vectors" ranges in value between 0 and 5, and the computed score, combining each vector score, ranges in value from 0 - 10. 95% confidence interval of the mean difference for the change in scores will be calculated. To test for differences in DCCS Computed scores change, either a two-sample t-test or Wilcoxon's rank sum test will be used, depending on the normality assumption.
次要结局
- Change in Vineland-3 Score from Baseline to Week 12(Baseline (Week 0), Post-treatment (Week 12))
- Change in NIHTB-CB DCCS Computed Score from Baseline to Week 16(Baseline (Week 0), Follow-up (Week 16))
- Change in Vineland-3 Score from Baseline to Week 16(Baseline (Week 0), Follow-up (Week 16))
- Change in BRIEF-P or BRIEF-2 Global Executive Composite Score from Baseline to Week 12(Baseline (Week 0), Post-treatment (Week 12))
- Change in BRIEF-P or BRIEF-2 Global Executive Composite Score from Baseline to Week 16(Baseline (Week 0), Follow-up (Week 16))