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

Description

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

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Mild Intellectual Disability
Intervention / Treatment

-

Contacts and Locations

San Francisco

UCSF Nancy Friend Pritzker Psychiatry Building, San Francisco, California, United States, 94107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Children aged 4-8 years (48-96 months) of both genders at the time of obtaining consent.
  • 2. 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.
  • 3. 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.
  • 4. 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.
  • 1. 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.
  • 2. 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.
  • 3. 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).
  • 4. Other subjects who are deemed unsuitable for participation in this clinical trial based on the judgment of the investigators.

Ages Eligible for Study

4 Years to 8 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Young Shin Kim, MD PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2024-10