EndeavorOTC® Research Study in College Students

NCT06376032 | Active Not Recruiting FDA Device

• 1 other identifier: Akili-068
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief 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. This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students.

Conditions

Attention; Cognition; University Students

Outcome Measures

Primary Outcomes (7)

• 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.

  Baseline, Exit (Day 84)

• 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.

  Baseline, Day 42, Day 84

• 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.

  Baseline, Day 42, Day 84

• 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.

  Baseline, Day 42, Day 84

• 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.

  Baseline, Day 42, Day 84

• 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.

  Baseline, Day 42, Day 84

• 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.

  Baseline, Day 42, Day 84

Other Outcomes (1)

• System Usability Scale (SUS)

  Day 84

Study Arms (2)

Group 1

EXPERIMENTAL

Participants receive immediate 12-week access to EndeavorOTC.

Device: EndeavorOTC®

Group 2

EXPERIMENTAL

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

Device: EndeavorOTC®

Interventions

EndeavorOTC® DEVICE

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.

Also known as: AKL-T01A

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead
• Landmark College: collaborator
• Villa Maria College: collaborator

Study Sites (2)

Villa Maria College

Cheektowaga, New York, 14225, United States

Location

Landmark College

Putney, Vermont, 05346, United States

Location

Study Officials

• Caitlin Stamatis, PhD

  Akili Interactive Labs, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: January 10, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)