ADHDNCT06109051
EndeavorOTC™ Prospective Product Registry
An observational study of ADHD, run by Akili Interactive Labs, Inc. at 1 site in United States.
Trial summary
The EndeavorOTC product registry aims to collect real world data from EndeavorOTC users. The objectives of this registry are to describe clinical and demographic characteristics, treatment patterns, clinical and quality of life outcomes, and healthcare utilization in EndeavorOTC users in a real-world setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ADHD
- What is being tested?
- EndeavorOTC
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: EndeavorOTC users may enroll and participate in the product registry for the full year regardless of the length of their EndeavorOTC subscription.
Who may be able to join
- Has an active EndeavorOTC™subscription
- Provide informed consent to participate in the registry
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Akili Interactive Labs, Inc.
Boston, Massachusetts, 02110
About this study
The EndeavorOTC product registry aims to collect real world data from EndeavorOTC users. The objectives of this registry are to describe clinical and demographic characteristics, treatment patterns, clinical and quality of life outcomes, and healthcare utilization in EndeavorOTC users in a real-world setting.
Read the detailed description
All EndeavorOTC users who subscribe to EndeavorOTC are invited to participate in this product registry. Users must provide their informed consent and have an active subscription to the product at time of enrollment to participate. Study activities are emailed to participants at baseline, 1, 2, 3, 6, 9, and 12-months after enrollment. Study activities consist of an online survey and online ADHD assessment. All data are captured electronically and securely through commercial data capture platforms.
- Conditions
- ADHD
- Being tested
- EndeavorOTC
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndeavorOTCDevice
Also called AKL-T01A
EndeavorOTC™ is an over-the-counter digital therapeutic designed to improve attention function, ADHD symptoms, and quality of life in users 18 years of age and older with primarily inattentive or combined-type ADHD, who have been identified as having a significant attentional impairment. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention function in children ages 8-12. EndeavorOTC is not intended to be a replacement for any form of ongoing treatment. 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 group | Role | What they receive |
|---|---|---|
| EndeavorOTC Users | All users who subscribe to EndeavorOTC for any duration Receives: Device: EndeavorOTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, Months 1, 2, 3, 6, 9, 12
Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S)
Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) provides an assessment of symptoms and behaviors associated with ADHD in adults ages 18 and older. The short versions of the self-report form (CAARS-S:S) contain 26 items that are scored on a scale of 0 (Not at all, never), 1 (Just a little, once in a while), 2 (Pretty much, often), and 3 (Very much, very frequently).
Negative change in score indicates improvement in ADHD symptoms and behaviors.
Measured: Baseline, Months 1, 2, 3, 6, 9, 12
Adult ADHD Quality of Life (AAQoL)
Adult ADHD Quality of Life (AAQoL) is a 29-item, self-report measure of functioning in a variety of life domains and adult roles. Items are rated on a 5-point scale that are transformed into a 0-100 scale, with higher scores reflecting higher quality of life. Scores are calculated for life productivity, psychological health, life outlook, and relationships, in addition to total score.
Positive change in score indicates improvement in quality of life.
Measured: Baseline, Months 1, 2, 3, 6, 9, 12
Patient Health Questionnaire - 4 items (PHQ-4)
Patient Health Questionnaire - 4 items (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 in score indicates improvement in anxiety and depression.
Measured: Baseline, Months 1, 2, 3, 6, 9, 12
Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) is a questionnaire that assesses the utilization of medical care and productivity loss. Select questions from the TIC-P questionnaire will be used to estimate costs of healthcare utilization. This assessment will be administered once every 3 months. Participants are asked to provide the number of appointments they have had with a specific healthcare provider or service in the past three months. The sum of total number of appointments utilized within a three month period will be compared between study time points.
Negative change in total number of appointments indicates improvement.
Measured: Baseline, Months 3, 6, 9, 12
Percent work time missed due to ADHD, as measured by Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity.
Negative change indicates improvement.
Measured: Baseline, Months 1, 2, 3, 6, 9, 12
Percent impairment while working due to ADHD, as measured by WPAI+CIQ:ADHD
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity.
Negative change indicates improvement.
Measured: Baseline, Months 1, 2, 3, 6, 9, 12
Percent overall work impairment due to ADHD, as measured by WPAI+CIQ:ADHD
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity.
Negative change indicates improvement.
Measured: Baseline, Months 1, 2, 3, 6, 9, 12
Percent class time missed due to ADHD, as measured by WPAI+CIQ:ADHD
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity.
Negative change indicates improvement.
Measured: Baseline, Months 1, 2, 3, 6, 9, 12
Percent overall classroom impairment due to ADHD, as measured by WPAI+CIQ:ADHD
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity.
Negative change indicates improvement.
Measured: Baseline, Months 1, 2, 3, 6, 9, 12
Percent activity impairment due to ADHD, as measured by WPAI+CIQ:ADHD
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity.
Negative change indicates improvement.
Measured: Baseline, Months 1, 2, 3, 6, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start3 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Akili Interactive Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott H Kollins, PhD, Principal investigator, Akili Interactive Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109051
- Sponsor's protocol ID
- Akili-065
- Status last verified
- Jun 2024
- First submitted
- 23 Oct 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndeavorOTC™ Prospective Product Registry
- ClinicalTrials.gov ID
- NCT06109051
- Acronym / sponsor ID
- Akili-065
- Conditions
- ADHD
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Akili Interactive Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EndeavorOTC product registry aims to collect real world data from EndeavorOTC users. The objectives of this registry are to describe clinical and demographic characteristics, treatment patterns, clinical and quality of life outcomes, and healthcare utilization in EndeavorOTC users in a real-world setting.
Detailed description
All EndeavorOTC users who subscribe to EndeavorOTC are invited to participate in this product registry. Users must provide their informed consent and have an active subscription to the product at time of enrollment to participate. Study activities are emailed to participants at baseline, 1, 2, 3, 6, 9, and 12-months after enrollment. Study activities consist of an online survey and online ADHD assessment. All data are captured electronically and securely through commercial data capture platforms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndeavorOTC Users | – | Device: EndeavorOTCAll users who subscribe to EndeavorOTC for any duration |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- EndeavorOTC users may enroll and participate in the product registry for the full year regardless of the length of their EndeavorOTC subscription.
Key inclusion criteria (2 listed)
- Has an active EndeavorOTC™subscription
- Provide informed consent to participate in the registry
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndeavorOTCAlso: AKL-T01AEndeavorOTC™ is an over-the-counter digital therapeutic designed to improve attention function, ADHD symptoms, and quality of life in users 18 years of age and older with primarily inattentive or combined-type ADHD, who have been identified as having a significant attentional impairment. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention function in children ages 8-12. EndeavorOTC is not intended to be a replacement for any form of ongoing treatment. 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. | Device | EndeavorOTC Users |
Primary outcome
Computerized Adaptive Test, Mental Health (CAT-MH®)
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
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.
Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S)
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) provides an assessment of symptoms and behaviors associated with ADHD in adults ages 18 and older. The short versions of the self-report form (CAARS-S:S) contain 26 items that are scored on a scale of 0 (Not at all, never), 1 (Just a little, once in a while), 2 (Pretty much, often), and 3 (Very much, very frequently). Negative change in score indicates improvement in ADHD symptoms and behaviors.
Adult ADHD Quality of Life (AAQoL)
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
Adult ADHD Quality of Life (AAQoL) is a 29-item, self-report measure of functioning in a variety of life domains and adult roles. Items are rated on a 5-point scale that are transformed into a 0-100 scale, with higher scores reflecting higher quality of life. Scores are calculated for life productivity, psychological health, life outlook, and relationships, in addition to total score. Positive change in score indicates improvement in quality of life.
Patient Health Questionnaire - 4 items (PHQ-4)
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
Patient Health Questionnaire - 4 items (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 in score indicates improvement in anxiety and depression.
Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Time frame: Baseline, Months 3, 6, 9, 12
Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) is a questionnaire that assesses the utilization of medical care and productivity loss. Select questions from the TIC-P questionnaire will be used to estimate costs of healthcare utilization. This assessment will be administered once every 3 months. Participants are asked to provide the number of appointments they have had with a specific healthcare provider or service in the past three months. The sum of total number of appointments utilized within a three month period will be compared between study time points. Negative change in total number of appointments indicates improvement.
Percent work time missed due to ADHD, as measured by Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity. Negative change indicates improvement.
Percent impairment while working due to ADHD, as measured by WPAI+CIQ:ADHD
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity. Negative change indicates improvement.
Percent overall work impairment due to ADHD, as measured by WPAI+CIQ:ADHD
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity. Negative change indicates improvement.
Percent class time missed due to ADHD, as measured by WPAI+CIQ:ADHD
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity. Negative change indicates improvement.
Percent overall classroom impairment due to ADHD, as measured by WPAI+CIQ:ADHD
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity. Negative change indicates improvement.
Percent activity impairment due to ADHD, as measured by WPAI+CIQ:ADHD
Time frame: Baseline, Months 1, 2, 3, 6, 9, 12
Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0 is a 10-item, validated self-report questionnaire which is based on an individual's absenteeism, presenteeism, work or classroom productivity loss, and activity impairment due to a specific disease/condition. This questionnaire has been adapted to the specific health problem of ADHD. Outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity. Negative change indicates improvement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott H Kollins, PhD principal investigator
Akili Interactive Labs, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Akili Interactive Labs, Inc. at 1 site 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 2 inclusion and 1 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: under way, not looking for participants, 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
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, Months 1, 2, 3, 6, 9, 12). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.