Mild Intellectual DisabilityNCT05933005
Intervention Utilizing a Computerized Cognitive Rehabilitation Program (D-kit/EF1)
A study testing D-kit/EF1 in people with Mild Intellectual Disability and Borderline Intellectual Functioning, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Mild Intellectual Disability, Borderline Intellectual Functioning
- What is being tested?
- D-kit/EF1
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, California, 94107
About this study
Official title: 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)
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.
Read the detailed description
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.
- Being tested
- D-kit/EF1, Sham group program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-kit/EF1Device
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.
Sham group programDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| D-kit/EF1 group | Experimental | 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. Receives: Device: D-kit/EF1 |
| Sham group | Sham comparator | 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.. Receives: Device: Sham group program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Post-treatment (Week 12)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 0), Follow-up (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start9 Aug 2023
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- DoBrain Inc., Korea Health Industry Development Institute
- Responsible party
- Sponsor
- Investigators
- Young Shin Kim, MD PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933005
- Sponsor's protocol ID
- 23-39462
- Status last verified
- Oct 2025
- First submitted
- 27 Jun 2023
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05933005
- Acronym / sponsor ID
- 23-39462
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- DoBrain Inc., Korea Health Industry Development Institute
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 6 Jul 2023 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-kit/EF1 group | Experimental | Device: D-kit/EF1The 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. |
| Sham group | Sham comparator | Device: Sham group programThe 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.. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| D-kit/EF1D-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. | Device | D-kit/EF1 group |
| Sham group programThe 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. | Device | Sham group |
Primary outcome
Change in NIHTB-CB DCCS Computed Score from Baseline to Week 12
Time frame: 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.
5 secondary outcomes
Change in NIHTB-CB DCCS Computed Score from Baseline to Week 16
Time frame: Baseline (Week 0), Follow-up (Week 16)
Change in Vineland-3 Score from Baseline to Week 12
Time frame: Baseline (Week 0), Post-treatment (Week 12)
Change in Vineland-3 Score from Baseline to Week 16
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
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
Time frame: Baseline (Week 0), Follow-up (Week 16)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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. This study is not recruiting at the moment.
Young Shin Kim, MD PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-kit/EF1 in people with Mild Intellectual Disability and Borderline Intellectual Functioning, run by University of California, San Francisco 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 3 Nov 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NIHTB-CB DCCS Computed Score from Baseline to Week 12 (time frame: Baseline (Week 0), Post-treatment (Week 12)). 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 3 Nov 2025.