protocolSection identificationModule nctId: NCT06376032, orgStudyIdInfo id: Akili-068, briefTitle: EndeavorOTC® Research Study in College Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Akili Interactive Labs, Inc., class: INDUSTRY, collaborators name: Landmark College, collaborators name: Villa Maria College, descriptionModule briefSummary: 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., conditionsModule conditions: Attention, conditions: Cognition, conditions: University Students, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 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., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: EndeavorOTC®, outcomesModule primaryOutcomes measure: Computerized Adaptive Test, Mental Health (CAT-MH®), primaryOutcomes measure: PROMIS Cognitive Function v2.0 - Short Form, primaryOutcomes measure: PROMIS Satisfaction with Participation in Discretionary Social Activities (v1.0), primaryOutcomes measure: General Academic Self-Efficacy scale (GASE), primaryOutcomes measure: Mental Health Quality of Life Scale (MHQoL), primaryOutcomes measure: Adult ADHD Self-Report Scale (ASRS), primaryOutcomes measure: Patient Health Questionnaire-4 (PHQ-4), otherOutcomes measure: System Usability Scale (SUS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Villa Maria College, status: RECRUITING, city: Cheektowaga, state: New York, zip: 14225, country: United States, contacts name: Laura Pietak, role: CONTACT, phone: 716-961-2869, email: lpietak@villa.edu, geoPoint lat: 42.90339, lon: -78.75475, locations facility: Landmark College, status: RECRUITING, city: Putney, state: Vermont, zip: 05346, country: United States, contacts name: Rick Bryck, PhD, role: CONTACT, phone: 802-387-6306, email: rickbryck@landmark.edu, geoPoint lat: 42.9748, lon: -72.52176, hasResults: False