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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Mild Intellectual Disability; Borderline Intellectual Functioning

Treatments: Device: D-kit/EF1; Device: Sham group program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05933005

23-39462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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11 participants in 2 patient groups

D-kit/EF1 group

Experimental group

Description:

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.

Treatment:

Device: D-kit/EF1

Sham group

Sham Comparator group

Description:

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..

Treatment:

Device: Sham group program