Intervention Utilizing a Computerized Cognitive Rehabilitation Program (D-kit/EF1)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Mild Intellectual Disability, Borderline Intellectual Functioning

Intervention / Treatment
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* Device: D-kit/EF1
* Device: Sham group program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 50-85. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: D-kit/EF1 group<br>The experimental group will use the D-kit/EF1 program on a mobile tablet device at least 5 times a week for 30 minutes each session, for a duration of 12 weeks. The program will be performed under the supervision of the participant's parents or primary caregivers, following the provided program usage guide. | Device: D-kit/EF1<br>* 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. The core technology of the D-kit/EF1 is the 'reinforcement technique', a technology used in traditional behavioral therapy. Specifically, D-kit incorporates the Discrete Trial Training (DTT) approach into its instructional content to facilitate the acquisition of basic cognitive skills.<br>|
| Sham Comparator: Sham group<br>The sham group will watch an educational animation video on a mobile tablet device at least 5 times a week for 30 minutes each session, for a duration of 12 weeks. The sham program was designed to provide a similar experience as the experimental group by replacing the content within the same app. The control group uses the same mobile tablet device and accesses the app with the provided control group account. When accessing the app with the control group account, instead of the Adaptive Learning Lesson reflecting the principles of D-kit, educational animations created for educational purposes are provided. The educational animations are original animations created by DOBAIN Inc.. | Device: Sham group program<br>* The sham program was designed to provide a similar experience as the experimental group by replacing the content within the same app. The control group uses the same mobile tablet device and accesses the app with the provided control group account. When accessing the app with the control group account, instead of the Adaptive Learning Lesson reflecting the principles of D-kit, educational animations created for educational purposes are provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NIHTB-CB DCCS Computed Score from Baseline to 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. | Baseline (Week 0), Post-treatment (Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NIHTB-CB DCCS Computed Score from Baseline to Week 16 | 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. | Baseline (Week 0), Follow-up (Week 16) | 
| Change in Vineland-3 Score from Baseline to Week 12 | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is a parent interview that measures a child's everyday adaptive skills at home and in the community in the areas of: Communication, Daily Living Skills, Socialization, and Motor. Each domain and the overall Adaptive Behavior Composite (ABC) result in a norm-referenced standard score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. Individuals with domain and ABC Standard Scores of 130 to 140 are considered to have a high adaptive level, 115 to 129 is considered moderately high, 86 to 114 as adequate, 71 to 85 as moderately low and 20 to 70 as low. | Baseline (Week 0), Post-treatment (Week 12) | 
| Change in Vineland-3 Score from Baseline to Week 16 | The Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) is a parent interview that measures a child's everyday adaptive skills at home and in the community in the areas of: Communication, Daily Living Skills, Socialization, and Motor. Each domain and the overall Adaptive Behavior Composite (ABC) result in a norm-referenced standard score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. Individuals with domain and ABC Standard Scores of 130 to 140 are considered to have a high adaptive level, 115 to 129 is considered moderately high, 86 to 114 as adequate, 71 to 85 as moderately low and 20 to 70 as low. | Baseline (Week 0), Follow-up (Week 16) | 
| Change in BRIEF-P or BRIEF-2 Global Executive Composite Score from Baseline to Week 12 | Behavior Rating Inventory of Executive Function Preschool (BRIEF-P) and Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2) measure multiple aspects of executive functioning. BRIEF-P is administered for children aged 4 at point of evaluation, and BRIEF-2 is administered for children aged 5 or older at point of evaluation. T scores are used to interpret the child's level of executive functioning on the BRIEF-P and BRIEF-2. T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated. | Baseline (Week 0), Post-treatment (Week 12) | 
| Change in BRIEF-P or BRIEF-2 Global Executive Composite Score from Baseline to Week 16 | Behavior Rating Inventory of Executive Function Preschool (BRIEF-P) and Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF-2) measure multiple aspects of executive functioning. BRIEF-P is administered for children aged 4 at point of evaluation, and BRIEF-2 is administered for children aged 5 or older at point of evaluation. T scores are used to interpret the child's level of executive functioning on the BRIEF-P and BRIEF-2. T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated. | Baseline (Week 0), Follow-up (Week 16) |