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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
11
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.
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.
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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.
Time frame: Baseline (Week 0), Post-treatment (Week 12)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0), Follow-up (Week 16)
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