D2D Normative Data for Remote Assessments
Condition: Cognition
Study type: Observational

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
    

Intervention name(s): Cognitive Assessments (Phase 1); Cognitive Battery A (Phase 2); Cognitive Battery B (Phase 2); Cognitive Battery C (Phase 2)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will participate in up to 6 assessments in 4 domains of cognition: Processing Speed; Executive Attention; Learning and Memory; and Social Cognition.
Assessments:
Visual Sweeps
Sustained Visual Attention
Associative Learning--Visual
Associative Learning--Auditory
Emotion Motion
Voice Choice; Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete self-report surveys.
Assessments:
On trails: Learning
Line Length Discrimination
Tap the Emotion
Sound Sweeps
BIS/BAS
TEPS
Feasibility survey; Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete the complete self-report surveys.
Assessments:
Visual Time Order Judgment
Target Tracker
Emotional Face
Auditory Sound Discrimination
BIS/BAS
TEPS
Feasiblity assessment; Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant willcomplete self-report surveys.
Assessments:
Stroop 2AFC
Visual Task Switcher
Beep Seeker
Voice Choice
BIS/BAS
TEPS
Feasibility Survey
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.
      
Keywords: cognitive training; Self-report assessments; Normative Data