Cognitive rehabilitation program for children with mild intellectual disabilities

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)

This study tests if a fun computer program can help young children with mild intellectual disabilities improve their thinking skills better than just watching educational videos.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 4 Years to 8 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05933005 on ClinicalTrials.gov

What this trial studies

This exploratory clinical trial aims to evaluate the effects of a computerized cognitive rehabilitation program, D-kit/EF1, on children aged 4-8 years with borderline intellectual functioning or mild intellectual disability. Participants will engage with the program on an iOS device for 30 minutes, five times a week, over a 12-week period. The study employs a randomized, double-blind, parallel-group design, comparing the cognitive improvements of those using D-kit/EF1 against a sham group watching educational videos. The program is designed to enhance executive function through game-type quizzes tailored for children with delayed cognitive development.

Who should consider this trial

Good fit: Ideal candidates are children aged 4-8 years with borderline intellectual functioning or mild intellectual disability, as defined by specific cognitive assessment criteria.

Not a fit: Patients with cognitive abilities outside the specified range or those unable to participate in the required assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve cognitive skills in children with mild intellectual disabilities or borderline intellectual functioning.

How similar studies have performed: While the approach of using computerized cognitive rehabilitation is gaining traction, this specific program's efficacy remains exploratory and has not been widely tested in similar studies.

Eligibility criteria

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.

Where this trial is running

San Francisco, California

• UCSF Nancy Friend Pritzker Psychiatry Building — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Young Shin Kim, MD PhD — University of California, San Francisco
• Study coordinator: Yusol A Park

Conditions Mild Intellectual Disability; Borderline Intellectual Functioning