Intervention Utilizing a Computerized Cognitive Rehabilitation Program (D-kit/EF1)
Mild Intellectual Disability, Borderline Intellectual Functioning
About this trial
This is an interventional treatment trial for Mild Intellectual Disability
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- UCSF Nancy Friend Pritzker Psychiatry BuildingRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
D-kit/EF1 group
Sham group
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.
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..