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

NCT05933005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-11-03

No results posted yet for this study

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

Interventions

DEVICE

D-kit/EF1

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.

DEVICE

Sham group program

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.

Sponsors & Collaborators

Principal Investigators

  • Young Shin Kim, MD PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2024-04-01
Completion
2024-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933005 on ClinicalTrials.gov