Clinical trial NCT06376032: EndeavorOTC® Research Study in College Students
Official title: EndeavorOTC® Research Study in College Students
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Attention
Cognition
University Students
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Landmark College
name: Villa Maria College
First posted: 2024-04-19
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Computerized Adaptive Test, Mental Health (CAT-MH®)
timeFrame: Baseline, Exit (Day 84)
measure: PROMIS Cognitive Function v2.0 - Short Form
timeFrame: Baseline, Day 42, Day 84
measure: PROMIS Satisfaction with Participation in Discretionary Social Activities (v1.0)
timeFrame: Baseline, Day 42, Day 84
measure: General Academic Self-Efficacy scale (GASE)
timeFrame: Baseline, Day 42, Day 84
measure: Mental Health Quality of Life Scale (MHQoL)
timeFrame: Baseline, Day 42, Day 84
measure: Adult ADHD Self-Report Scale (ASRS)
timeFrame: Baseline, Day 42, Day 84
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline, Day 42, Day 84
Secondary outcomes:
Other outcomes:
measure: System Usability Scale (SUS)
timeFrame: Day 84
Locations:
city: Cheektowaga
country: United States
facility: Villa Maria College
state: New York
city: Putney
country: United States
facility: Landmark College
state: Vermont
Study officials:
affiliation: Akili Interactive Labs, Inc.
name: Caitlin Stamatis, PhD
role: PRINCIPAL_INVESTIGATOR
References: