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

NCT05933005 | Completed DMC FDA Device

• 1 other identifier: 23-39462
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Intellectual Disability; Borderline Intellectual Functioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 12

  Baseline (Week 0), Post-treatment (Week 12)

• 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)

Study Arms (2)

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.

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..

Device: Sham group program

Interventions

D-kit/EF1 DEVICE

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.

D-kit/EF1 group

Sham group program DEVICE

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.

Sham group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• DoBrain Inc.: collaborator
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, 94107, United States

Location

Study Officials

• Young Shin Kim, MD PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 6, 2023
• Study Start: August 9, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)