- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06376032
EndeavorOTC® Research Study in College Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Cheektowaga, New York, United States, 14225
- Villa Maria College
-
-
Vermont
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Putney, Vermont, United States, 05346
- Landmark College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Owns a personal Android or iOS device to access AKL-T01 treatment
- Provides informed consent to participate in this study
- Is 18 years of age or older
Exclusion Criteria:
- Known photosensitive epilepsy, color blindness, and any physical limitation that would make engagement with an app-based digital intervention difficult
- Has participated in the same study in previous semesters
Pregnant and nursing people are eligible to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Participants receive immediate 12-week access to EndeavorOTC.
|
EndeavorOTC is an over the counter digital therapeutic designed to improve attention function as measured by computer-based testing in patients 18 and older with primarily inattentive or combined type ADHD, who have a demonstrated attention issue.
EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx®, an FDA-authorized prescription digital therapeutic indicated to improve attention function in children ages 8-17.
EndeavorOTC is deployed on mobile devices and incorporates adaptive, simultaneous cognitive tasks in a consumer-grade action videogame-based platform with high-quality graphics and reward mechanisms.
Other Names:
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Experimental: Group 2
Participants receive 12-week access to EndeavorOTC 6-weeks after Group 1.
|
EndeavorOTC is an over the counter digital therapeutic designed to improve attention function as measured by computer-based testing in patients 18 and older with primarily inattentive or combined type ADHD, who have a demonstrated attention issue.
EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx®, an FDA-authorized prescription digital therapeutic indicated to improve attention function in children ages 8-17.
EndeavorOTC is deployed on mobile devices and incorporates adaptive, simultaneous cognitive tasks in a consumer-grade action videogame-based platform with high-quality graphics and reward mechanisms.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Computerized Adaptive Test, Mental Health (CAT-MH®)
Time Frame: Baseline, Exit (Day 84)
|
Computerized Adaptive Test, Mental Health (CAT-MH®) is a distinct suite of computer adaptive tests that is based on multidimensional item response theory. The adult ADHD module is a dimensional severity measure of attention-deficit/hyperactivity disorder symptomatology for adults 18 and over. The number and selection of questions within the assessment varies as individuals' initial item responses are used to determine a provisional estimate of their standing on the measured trait to be used for subsequent item selection. Items are scored on a Likert scale of 1 (Not at all), 2 (Just a little), 3 (Somewhat), 4 (Quite a bit), and 5 (Very much). Negative change in score indicates improvement in ADHD severity. |
Baseline, Exit (Day 84)
|
PROMIS Cognitive Function v2.0 - Short Form
Time Frame: Baseline, Day 42, Day 84
|
The PROMIS Cognitive Function v2.0 short form consists of six questions about the respondent's cognitive function in the past 7 days rated on a Likert scale of 1-5, where 1=Very often (Several times a day) and 5=Never. Higher score indicates higher levels of cognition. Positive change in score indicates improvement. |
Baseline, Day 42, Day 84
|
PROMIS Satisfaction with Participation in Discretionary Social Activities (v1.0)
Time Frame: Baseline, Day 42, Day 84
|
The PROMIS Satisfaction with Participation in Discretionary Social Activities scale consists of 7 questions about the respondent's satisfaction in the past 7 days rated on a Likert scale of 1-5 where 1=Not at all and 5=Very much. Higher score indicates more satisfaction. Positive change in score indicates improvement. |
Baseline, Day 42, Day 84
|
General Academic Self-Efficacy scale (GASE)
Time Frame: Baseline, Day 42, Day 84
|
The GASE is a short and concise five-item measure of the longer form Academic self-efficacy (ASE) scale. The scale assesses a student's global belief in his or her ability to master the various academic challenges in an academic setting and is considered an essential antecedent of wellbeing and performance. Higher score indicates more self-efficacy. Positive change in score indicates improvement. |
Baseline, Day 42, Day 84
|
Mental Health Quality of Life Scale (MHQoL)
Time Frame: Baseline, Day 42, Day 84
|
The MHQoL is a standardized, validated self-report measure of quality of life that has been developed for use in people with mental health problems.18 It consists of 7-items covering self-image, independence, mood, relationships, daily activities, physical health, and future measured on a 4-point Likert scale ranging from "Very satisfied" to "Very dissatisfied," and an analogue scale from regarding psychological well-being where 0 = "worst imaginable psychological well-being" and 10 = "best imaginable psychological well-being." Higher score indicates a better quality of life. Positive change in score indicates improvement. |
Baseline, Day 42, Day 84
|
Adult ADHD Self-Report Scale (ASRS)
Time Frame: Baseline, Day 42, Day 84
|
The ASRS v1.1 is an 18-item self-report validated questionnaire designed to assess ADHD symptoms in adults. No total score or diagnostic likelihood is utilized for the twelve questions. Frequency scores are used to determine if the patient has symptoms highly consistent with ADHD in adults. The frequency-based response is more sensitive with certain questions. Greater frequency indicates higher symptom consistency with ADHD in adults. Negative change indicates improvement. |
Baseline, Day 42, Day 84
|
Patient Health Questionnaire-4 (PHQ-4)
Time Frame: Baseline, Day 42, Day 84
|
PHQ-4 is an ultra-brief, validated screening assessment for anxiety and depression, consisting of four-items that are scored on a Likert scale of 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day). A higher score indicates greater levels of depression and anxiety. Negative change indicates improvement. |
Baseline, Day 42, Day 84
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System Usability Scale (SUS)
Time Frame: Day 84
|
The SUS is a brief, validated 10-item questionnaire that is designed to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.22
The SUS consists of 10 items rated on a 5-point Likert scale that range from "strongly agree" to "strongly disagree."
Results interpretation typically requires normalizing the scores to produce a percentile ranking; however, a SUS score above 68 can generally be considered above average, and a score below 68, generally considered below average.
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Day 84
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Caitlin Stamatis, PhD, Akili Interactive Labs, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Akili-068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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