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Behavioural Intervention

Cognitive Rehabilitation Program for Intellectual Disability

N/A

Recruiting

Led By Young Shin Kim, MD PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children aged 4-8 years (48-96 months) of both genders at the time of obtaining consent.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), follow-up (week 16)

Awards & highlights

Study Summary

This trial tests if using a computer program for 30 min, 5 days a week for 12 weeks can help children with mild intellectual disability improve their cognitive skills.

Who is the study for?

This trial is for children aged 4-8 with borderline intellectual functioning or mild intellectual disability. They must be able to communicate and participate in tests and activities, and their legal guardians must consent. Children who can't see, hear well, or have been in another drug trial recently can't join.Check my eligibility

What is being tested?

The study examines a computerized cognitive rehabilitation program (D-kit/EF1) used on an iOS device versus a sham group watching educational videos. Kids will use the program or watch videos five times a week for 30 minutes over 12 weeks.See study design

What are the potential side effects?

Since this trial involves cognitive training using digital devices, side effects might include eye strain, headache from screen exposure, or frustration if tasks are challenging. However, specific side effects of D-kit/EF1 aren't detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 4 and 8 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), follow-up (week 16)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), follow-up (week 16)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), follow-up (week 16) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in NIHTB-CB DCCS Computed Score from Baseline to Week 12

Secondary outcome measures

Change in BRIEF-P or BRIEF-2 Global Executive Composite Score from Baseline to Week 12

Change in BRIEF-P or BRIEF-2 Global Executive Composite Score from Baseline to Week 16

Change in NIHTB-CB DCCS Computed Score from Baseline to Week 16

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: D-kit/EF1 groupExperimental Treatment1 Intervention

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.

Group II: Sham groupPlacebo Group1 Intervention

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..

0 / 1Eligibility criteria met

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Who is running the clinical trial?

DoBrain Inc.Industry Sponsor

University of California, San FranciscoLead Sponsor

2,506 Previous Clinical Trials

15,238,475 Total Patients Enrolled

2 Trials studying Intellectual Disability

809 Patients Enrolled for Intellectual Disability

Young Shin Kim, MD PhDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

D-kit/EF1 (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05933005 — N/A

Intellectual Disability Research Study Groups: D-kit/EF1 group, Sham group

Intellectual Disability Clinical Trial 2023: D-kit/EF1 Highlights & Side Effects. Trial Name: NCT05933005 — N/A

D-kit/EF1 (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05933005 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment accept participants over the age of 55?

"This trial is limited to applicants between the ages of 4 and 8. For those below 18, there are 25 other trials available while 14 more have been set up for participants that are over 65 years old."

Answered by AI

Is there room for additional participants in this research endeavor?

"This investigation, which was originally posted on September 1st 2023 and last updated on June 27th2023 is not currently accepting participants. Nevertheless, there are 35 other clinical trials that are actively searching for volunteers at present."

Answered by AI

What criteria must be met for a participant to become eligible for this research?

"This investigation is in need of 80 participants with an intellectual disability and between 4 to 8 years old. Qualified individuals will be allowed to join the clinical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Intervention Utilizing a Computerized Cognitive Rehabilitation Program (D-kit/EF1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05933005.