D2D Normative Data for Remote Assessments
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 12 - 80 |
| Updated: | 10/31/2018 |
| Start Date: | June 6, 2017 |
| End Date: | September 15, 2022 |
| Contact: | Neelu Ghiasi |
| Email: | vinod2d@umn.edu |
| Phone: | 612-625-1586 |
Collection of Normative Data for iPad-Based Cognitive Assessment Tools
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.
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.
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
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
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
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