Clinical trial NCT03206775: D2D Normative Data for Remote Assessments
Official title: Collection of Normative Data for iPad-Based Cognitive Assessment Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognition
Keywords: cognitive training
Self-report assessments
Normative Data
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Posit Science Corporation
First posted: 2017-07-02
Enrollment: 1271
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Phase 1: Participants in this study will be healthy adults, aged 18-65, who are fluent in English and do not have a history of schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, autism spectrum disorder, mental retardation, neurological disorder, or history of major head injury. Participants will not be restricted by their geological location as they can access the study portal remotely with a reliable internet connection. Pregnant women may participate in this study.

Phase 2: Participants in this study will be attendants of the Minnesota State Fair, aged 18-80, who learned English before the age of 12 and can use an iPad without assistance. Participants may be pregnant or have a medical, developmental, psychiatric, or neurological condition.

Brief summary: Phase 1: This is a remote observational study in which participants will complete cognitive assessments developed by Posit Science. Participants will be healthy controls aged 18-65 with reliable internet access and a device that they can use to access the assessments, such as a laptop or iPad. Participants will complete up to 6 Posit Science assessments in different domains of cognition, which should last approximately 30 minutes.

Phase 2: This is an in person observational study in which participants will complete cognitive assessments developed by Posit Science. Participants will be healthy controls aged 18-80 who are fluent in English. Participants will complete batteries of cognitive assessments developed by Posit Science, which include combinations of visual, auditory, and social cognitive assessments, and self-report questionnaires. This study will be conducted at the Driven to Discover building at the Minnesota State Fair. Participation will last approximately 20 minutes.

Phase 3: Participants in Phase 3 will complete a Posit Science assessment battery and self-report questionnaires. Each participant will be asked to provide brief demographic and medical history data. Participants will be aged 18-35 and will be students at the University of Minnesota who are enrolled in the Research Experience Points program. Participants will complete the assessment battery remotely; the battery will take approximately 45-60 minutes to complete.

Phase 4: This is a pilot program to test the use of remote cognitive assessment and training in adolescents with an anxiety diagnosis and healthy controls. Participants will complete a short assessment battery, then will receive 4 hours of cognitive training over 2 weeks at home. Then they will repeat the battery. Total participation should last approximately 5 hours over 2-3 weeks and will be completed entirely remotely.

Detailed description: Phase 1: Remote Assessment with Old Battery (Enrollment period: June-August 2017. CLOSED TO ENROLLMENT) Participants who have successfully completed the online consent process may begin study procedures. A member of the research staff will connect the participant to the Posit Science battery remotely using their laptop or iPad through the BrainHQ portal. All Posit Science assessments have a brief training section before the assessment begins. Participants will be instructed to be in a quiet place free of distractions where they can turn up the volume on their device or use headphones to complete the auditory portions of the assessment. The battery will consist of 6 exercises and will last approximately 20 minutes, which will be completed in a single sitting. Data to be captured will include response time, accuracy, and time to complete the assessment. These data will be stored confidentially within the Posit Science servers and will later be downloaded onto an external device for data analysis and interpretation. Once participants have completed the batter, a member of the study staff will send their compensation.

Phase 2: Minnesota State Fair (Enrollment period: 2017-2022) Participants who have successfully completed the consent process may begin study procedures. A member of the research staff will connect the participant to the REDCap self-report surveys on an iPad. The surveys will be contained within a directory listed under the participant's unique study identifier and will not contain any personally identifying information. The first survey will collect demographic information such as age, gender, ethnicity/race, zip code of residence, education level, current medications, and personal and familial psychiatric and neurological history. This information will be collected in a self-report survey form to avoid embarrassment or stigma that could result if the participant was overheard answering these questions. After completing the demographic survey and brief medical history, all participants will complete self report questionnaires. The self-report assessments should take approximately 2 minutes to complete.

After the completion of the self-report items, the participant will be automatically redirected to the cognitive battery to which they have been randomized. They will be asked to log in to the BrainHQ portal using the same email address they provided before. They will be prompted for their name; study staff will instruct participants to enter "State" for their first name and "Fair" for their last name. However, study staff will not directly oversee participants while they create their account, and so some may not follow these instructions and may disclose their full name to Posit Science. All Posit Science assessments have a brief training section before the assessment begins. If the participant is still having trouble understanding the assessment, study staff will be available to help explain the tasks. Participants will be provided with over-the-ear headphones with disposable sanitary pads for auditory components. Each battery will consist of 4-6 Posit Science assessments, which last approximately 2-3 minutes each. The cognitive battery should last approximately 12-15 minutes. Data to be captured will include response time, accuracy, and time to complete the assessment. These data will be stored confidentially within the Posit Science servers and will later be downloaded onto an AHC managed device for analysis and interpretation. When downloaded to the AHC server, they will be de-identified and collated using a unique participant ID.

At the end of the cognitive assessment battery, participants will be asked to complete a short feasibility survey on REDCap which will ask them their opinion of the tasks they completed and how likely they would be to use these kinds of programs. This survey should take approximately 1-2 minutes. Then participants will receive their compensation and their participation will be complete.

Phase 3: Research Experience Program (REP) Project (Enrollment period: Spring 2018; future enrollment planned) Adult students at the University of Minnesota who are enrolled in the Research Experience Points (REP) program may enroll in this study to be awarded points for class credit. We will request that participants complete the study in a quiet environment free of distractions with a reliable internet connection, and that they do not participate if they have consumed alcohol or illicit substances in the last 8 hours/are under the influence of illicit substances. We will also recommend the use of over-the-ear headphones for the study. Participants will complete an online consent form independently, though they may contact research staff at any time if they have questions. After completing the consent form, participants will be redirected to the COMPAS self-report measures. After the assessment suite is complete, the participants will be automatically re-directed to the Posit Science website to complete the assessment battery. Total participation should take approximately 45-60 minutes.

Phase 4: Pilot Adolescent Cognitive Training (Enrollment period: Summer 2018. CLOSED TO ENROLLMENT) We will recruit adolescents without a mental health diagnosis and with a diagnosis of anxiety by using the UMP Psychiatry Clinic recruitment registry, contacting previous research participants, by advertising in the community and online (Facebook and Department website). Parents/guardians will be asked to provide a brief demographic and medical history about their child. If the participant is over 18, they may complete this independently, but are instructed that they can work with their parent or guardian if they choose to do so. The adolescent will then complete the assessment battery, 4 hours of BrainHQ training games over 2 weeks, and repeat the assessment battery. Total participation should last approximate 5 hours and will be completed entirely remotely. Participants will receive their compensation via email, using the same account that was used for sending the link to the battery

Eligibility criteria: Phase 1 Inclusion Criteria:

* Aged 18-65
* Willing and able to provide informed consent as determined by the REDCap assessment
* Fluent in English (learned before the age of 12)
* Has reliable internet access and a device such as a laptop or iPad which can be used to connect to the BrainHQ portal in a quiet place free of distraction
* Able to use an iPad or computer to perform visual and auditory cognitive assessments unassisted
* No history of schizophrenia, bipolar disorder with psychosis, or schizoaffective disorder
* No neurological disorder, major head injury, mental retardation diagnosis, or autism spectrum disorder
* Pregnant women may participate in this study

Phase 2 Inclusion Criteria:

* Aged 18-80
* Willing and able to provide informed consent
* Learned English before the age of 12
* Pregnant women may participate in this study
* Able to use an iPad to perform visual and/or auditory cognitive assessments unassisted.

Phase 3 Inclusion Criteria:

* Aged 18-35
* Willing and able to provide informed consent Fluent in English Able to use an iPad or computer to perform visual and auditory cognitive assessments unassisted
* Has reliable internet access and a device such as a laptop or iPad which can be used to connect to the REDCap server and BrainHQ portal in a quiet place free of distraction

Phase 4 Inclusion Criteria:

* Aged 12-18
* Either has no mental health diagnosis (healthy control) or is diagnosed with an anxiety disorder
* Willing and able to provide assent; at least one parent or guardian is able to provide written consent for participation
* Fluent in English
* Consistent access to a device with the iOS operating system (e.g., iPhone, iPad)
* Able to use an iOS device to perform visual and auditory cognitive assessments unassisted
* Has reliable internet access in a quiet place free from distraction to complete study activities

Exclusion Criteria for all participants:

* Unable or unwilling to provide informed consent
* Not fluent in written/spoken English
* Unable to use an iPad or computer to complete visual and/or auditory cognitive assessments without assistance
* Presence of a medical or behavioral condition that would prohibit participation in the trial
* Participant has used illicit substances or alcohol within the past 8 hours

Primary outcomes:
measure: Visual Sweeps
timeFrame: 4 minutes
measure: Sustained Visual Attention
timeFrame: 4 minutes
measure: Associative Learning--Visual
timeFrame: 4 minutes
measure: Associative Learning--Auditory
timeFrame: 4 minutes
measure: Emotion Motion
timeFrame: 4 Minutes
measure: Voice Choice
timeFrame: 4 Minutes
measure: On Trails: Learning
timeFrame: 4 minutes
measure: Line Length Discrimination
timeFrame: 4 minutes
measure: Tap the Emotion
timeFrame: 4 minutes
measure: Sound Sweeps
timeFrame: 4 minutes
measure: Visual Time Order Judgment
timeFrame: 4 minutes
measure: Target Tracker
timeFrame: 4 minutes
measure: Emotional Face
timeFrame: 4 minutes
measure: Auditory Sound Discrimination
timeFrame: 4 minutes
measure: Stroop 2AFC
timeFrame: 4 minutes
measure: Visual Task Switcher
timeFrame: 4 minutes
measure: Beep Seeker
timeFrame: 4 minutes
measure: Voice Choice
timeFrame: 4 minutes
Secondary outcomes:
measure: Behavioral Inhibition Scale/Behavioral Activation Scale (BIS/BAS)
timeFrame: 4 minutes
measure: Temporal Experience of Pleasure Scale (TEPS)
timeFrame: 4 minutes
measure: Feasibility ratings
timeFrame: 1 minute
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Minneapolis
country: United States
facility: University of Minnesota, Dept of Psychiatry
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sophia Vinogradov, MD
role: PRINCIPAL_INVESTIGATOR
References: