Clinical trial NCT05933005: Intervention Utilizing a Computerized Cognitive Rehabilitation Program (D-kit/EF1)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Intellectual Disability
Borderline Intellectual Functioning
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: DoBrain Inc.
First posted: 2023-07-06
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Change in NIHTB-CB DCCS Computed Score from Baseline to Week 12
timeFrame: Baseline (Week 0), Post-treatment (Week 12)
Secondary outcomes:
measure: Change in NIHTB-CB DCCS Computed Score from Baseline to Week 16
timeFrame: Baseline (Week 0), Follow-up (Week 16)
measure: Change in Vineland-3 Score from Baseline to Week 12
timeFrame: Baseline (Week 0), Post-treatment (Week 12)
measure: Change in Vineland-3 Score from Baseline to Week 16
timeFrame: Baseline (Week 0), Follow-up (Week 16)
measure: Change in BRIEF-P or BRIEF-2 Global Executive Composite Score from Baseline to Week 12
timeFrame: Baseline (Week 0), Post-treatment (Week 12)
measure: Change in BRIEF-P or BRIEF-2 Global Executive Composite Score from Baseline to Week 16
timeFrame: Baseline (Week 0), Follow-up (Week 16)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Nancy Friend Pritzker Psychiatry Building
state: California
Study officials:
affiliation: University of California, San Francisco
name: Young Shin Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: