What side effects are associated with this type of intervention?

Common treatments for intellectual disability, particularly cognitive rehabilitation programs like D-kit/EF1, generally focus on improving cognitive function and adaptive skills. These treatments are typically well-tolerated, with minimal side effects. However, some patients may experience mild side effects such as increased hyperactivity. Other interventions, such as metabolic support therapy with Q10 ubiquinol, vitamin E, and complex-B vitamins, have also been reported to be well-tolerated, with the most frequent mild side effect being increased hyperactivity.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Intellectual Disability that directly align with cognitive rehabilitation programs like D-kit/EF1. However, various therapeutic approaches, including speech therapy, occupational therapy, and behavioral interventions, are commonly used to support individuals with Intellectual Disability. These therapies aim to improve cognitive function, communication skills, and daily living abilities. While pharmacological treatments may be used to manage associated symptoms or comorbid conditions, cognitive rehabilitation remains a key non-pharmacological strategy in the management of Intellectual Disability.

What other types of research exist?

Promising novel alternatives to D-kit/EF1 for cognitive rehabilitation in intellectual disability patients include: 1) T3D-959, a PPAR delta/gamma agonist showing cognitive improvements in Alzheimer's disease, which may have potential applications in intellectual disabilities. 2) SM07883, a DYRK1A inhibitor that has demonstrated reduction in tau pathology and neuroinflammation, with potential cognitive benefits. 3) Cognitive Behavioral Therapy for Insomnia (CBT-I), which has shown improvements in psychological well-being and functional health, and could be adapted for intellectual disability patients.

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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)

Summary

This trial tests a special program with fun games on tablets to help children with mild intellectual disabilities improve their thinking skills. The program aims to make their brains work better through consistent game play.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive rehabilitation for Intellectual Disability (ID) often involves structured programs designed to improve cognitive functions such as memory, attention, and problem-solving skills. These programs, like the D-kit/EF1, typically use repetitive, task-specific training to enhance neural plasticity and cognitive performance. The mechanisms of action include strengthening neural connections and promoting the development of new neural pathways through consistent practice and engagement in cognitive tasks. This is crucial for ID patients as it can lead to improved daily functioning, greater independence, and enhanced quality of life by addressing specific cognitive deficits and enabling better adaptation to everyday challenges.

The Clinical Trials Mosaic: Toward a Range of Clinical Trials Designs to Optimize Evidence-Based Treatment.Evaluation of a group based cognitive behavioural therapy programme for menstrual pain management in young women with intellectual disabilities: protocol for a mixed methods controlled clinical trial.