EndeavorOTC® Research Study in College Students
- Conditions
- AttentionCognitionUniversity Students
- Interventions
- Device: EndeavorOTC®
- Registration Number
- NCT06376032
- Lead Sponsor
- Akili Interactive Labs, Inc.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 69
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 2 EndeavorOTC® Participants receive 12-week access to EndeavorOTC 6-weeks after Group 1. Group 1 EndeavorOTC® Participants receive immediate 12-week access to EndeavorOTC.
- Primary Outcome Measures
Name Time Method Mental Health Quality of Life Scale (MHQoL) 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.Computerized Adaptive Test, Mental Health (CAT-MH®) 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.PROMIS Cognitive Function v2.0 - Short Form 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.PROMIS Satisfaction with Participation in Discretionary Social Activities (v1.0) 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.General Academic Self-Efficacy scale (GASE) 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.Adult ADHD Self-Report Scale (ASRS) 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.Patient Health Questionnaire-4 (PHQ-4) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Villa Maria College
🇺🇸Cheektowaga, New York, United States
Landmark College
🇺🇸Putney, Vermont, United States