AzTrials
AzTrials

AttentionNCT06376032

EndeavorOTC® Research Study in College Students

A study testing EndeavorOTC® in people with Attention and Cognition, run by Akili Interactive Labs, Inc. at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Attention, Cognition, University Students
What is being tested?
EndeavorOTC®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
2 sitesUnited States
Study dates
10 Jan 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Villa Maria College

    Cheektowaga, New York, 14225

  • Landmark College

    Putney, Vermont, 05346

Other trials in United States

About this study

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.

Read the detailed description

University students face an increased risk of mental health challenges, as well as elevated stress due to the demands of managing coursework and social stress during a formative developmental period with increased independence. Consequently, there is a need for scalable, evidence-based interventions that can help university students manage their cognitive and emotional health. Through a partnership between Akili Interactive Labs and participating colleges, free 12-week access to AKL-T01 will be provided to any student interested in treatment for the duration of an academic semester, up to an N of 500 per site. This study will evaluate changes in participants across a range of clinical and functional outcomes, including cognitive functioning, academic outcomes, social functioning, attention and associated symptoms, and quality of life. The study will also evaluate user feedback and information on the usability of AKL-T01 through both quantitative and qualitative methods.

Being tested
EndeavorOTC®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EndeavorOTC®Device

    Also called AKL-T01A

    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.

Study groups in NCT06376032
Study groupRoleWhat they receive
Group 1ExperimentalParticipants receive immediate 12-week access to EndeavorOTC.
Receives: Device: EndeavorOTC®
Group 2ExperimentalParticipants receive 12-week access to EndeavorOTC 6-weeks after Group 1.
Receives: Device: EndeavorOTC®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Computerized Adaptive Test, Mental Health (CAT-MH®)

    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.

    Measured: Baseline, Exit (Day 84)

  2. PROMIS Cognitive Function v2.0 - Short Form

    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.

    Measured: Baseline, Day 42, Day 84

  3. PROMIS Satisfaction with Participation in Discretionary Social Activities (v1.0)

    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.

    Measured: Baseline, Day 42, Day 84

  4. General Academic Self-Efficacy scale (GASE)

    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.

    Measured: Baseline, Day 42, Day 84

  5. Mental Health Quality of Life Scale (MHQoL)

    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.

    Measured: Baseline, Day 42, Day 84

  6. Adult ADHD Self-Report Scale (ASRS)

    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.

    Measured: Baseline, Day 42, Day 84

  7. Patient Health Questionnaire-4 (PHQ-4)

    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.

    Measured: Baseline, Day 42, Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2024
  2. Study start10 Jan 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Eligible students will be randomized\* to two cohorts: the first will receive immediate access to AKL-T01, and the second will complete weekly online surveys and receive access to AKL-T01 after the first group has completed the recommended 6 weeks of use. Regardless of group assignment, all participants will receive full 12-weeks of access to AKL-T01 during the course of the study. \*Depending on enrollment numbers for a given semester (e.g., if \<100 students are enrolled and the study is underpowered to conduct between-group comparisons), all participants may be assigned to receive treatment immediately (i.e., single-arm design) and primary study hypotheses may be evaluated according to within-person changes in outcomes.
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06376032
Sponsor's protocol ID
Akili-068
Status last verified
Jun 2024
First submitted
17 Apr 2024
Last updated
27 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: IPD will not be shared with other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing EndeavorOTC® in people with Attention and Cognition, run by Akili Interactive Labs, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Computerized Adaptive Test, Mental Health (CAT-MH®) (time frame: Baseline, Exit (Day 84)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06376032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
EndeavorOTC® Research Study in College Students | AzTrials