EndeavorOTC for Attention Deficit Disorder

Recruiting at 1 trial location

Overseen By Minny Suh, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Akili Interactive Labs, Inc.

Disqualifiers: Photosensitive epilepsy, color blindness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 42

Duration: 12 weeks

69 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to evaluate the impact of a digital therapeutic (EndeavorOTC®, also known as AKL-T01A) on clinical symptoms of executive and cognitive functioning in a real-world sample of university students. This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment EndeavorOTC® for Attention Deficit Disorder?

Research on similar game-based digital therapies, like EndeavorRx®, shows they can help improve attention and reduce hyperactivity in children with ADHD, although traditional medication may be more effective. ^{1 2 3 4 5}

Research Team

Caitlin Stamatis, PhD

Principal Investigator

Akili Interactive Labs, Inc.

Eligibility Criteria

This study is for university students who may have attention issues or want to improve their cognitive functioning. Participants should be interested in trying a digital therapeutic called EndeavorOTC®.

Inclusion Criteria

Owns a personal Android or iOS device to access AKL-T01 treatment

Provides informed consent to participate in this study

Exclusion Criteria

I don't have epilepsy, color blindness, or physical issues that make using apps hard.

Has participated in the same study in previous semesters

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12-week access to EndeavorOTC, a digital therapeutic, to evaluate its impact on cognitive and emotional health

12 weeks

Baseline, Day 42, Day 84 assessments

Follow-up

Participants are monitored for changes in cognitive functioning, academic outcomes, social functioning, attention, and quality of life

4 weeks

Treatment Details

Interventions

• EndeavorOTC®

Trial Overview The trial is testing the effects of a digital therapy app, EndeavorOTC®, on executive and cognitive functions in college students. It aims to see if this app can help with focus, memory, and other brain skills.

Participant Groups

Group I: Group 2 Experimental Treatment 1 Intervention

Participants receive 12-week access to EndeavorOTC 6-weeks after Group 1.

Group II: Group 1 Experimental Treatment 1 Intervention

Participants receive immediate 12-week access to EndeavorOTC.

Who Is Running the Clinical Trial?

Akili Interactive Labs, Inc.

Lead Sponsor

Trials

17

Recruited

2,100+

Landmark College

Collaborator

Trials

1

Recruited

70+

Villa Maria College

Collaborator

Trials

1

Recruited

70+

Findings from Research

Game-based digital therapeutics (DTx), like EndeavorRx®, significantly improved inattention and hyperactivity/impulsivity in children with ADHD compared to control groups, based on assessments from parents and teachers.

However, traditional medication was found to be more effective than game-based DTx in reducing inattention and hyperactivity/impulsivity, indicating that while DTx offers a beneficial alternative, it may not replace conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of game-based digital therapeutics on attention deficit hyperactivity disorder in children and adolescents as assessed by parents or teachers: a systematic review and meta-analysis. Oh, S., Choi, J., Han, DH., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effects of game-based digital therapeutics on attention deficit hyperactivity disorder in children and adolescents as assessed by parents or teachers: a systematic review and meta-analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Neurofeedback and cognitive attention training for children with attention-deficit hyperactivity disorder in schools. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A Controlled Evaluation of a Sport-Specific Performance Optimization Program in an Athlete Diagnosed With Attention Deficit Hyperactivity Disorder and Oppositional Defiant Disorder Within the Context of COVID-19. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of access to care and medical and behavioral outcomes in a school-based intervention program for attention-deficit hyperactivity disorder. [2019]

5. Brazil pubmed.ncbi.nlm.nih.gov

Attention deficit and hyperactivity disorder: a therapeutic option. [2021]