<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03834467</url>
  </required_header>
  <id_info>
    <org_study_id>17-0182</org_study_id>
    <nct_id>NCT03834467</nct_id>
  </id_info>
  <brief_title>Testing a Shortened Version of the AlAn's Game</brief_title>
  <official_title>Testing a Shortened Version of the AlAn's Game, Which Can be Delivered Through REDCap, in a Sample of Emerging Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been demonstrated that behavior on the AlAn's (altruism-antisocial) game is related to&#xD;
      Moral Elevation response. Moral Elevation is a positive response to another's act of&#xD;
      generosity &quot;of charity, gratitude, fidelity, generosity or any other strong display of&#xD;
      virtue&quot;. The constellation of emotional, physical and psychological aspects of a Moral&#xD;
      Elevation response have been well described. Moral Elevation can be elicited with stimulus&#xD;
      stories or videos and measured with self-report questionnaires. The experience of Moral&#xD;
      Elevation is associated with subsequent prosocial and affiliative behaviors. Additionally,&#xD;
      the research has linked Moral Elevation response with behavior on the AlAn's game. This study&#xD;
      will test whether behavior on the AlAn's Short Game v.2 is related to Moral Elevation&#xD;
      response and extend prior work by testing whether viewing the Moral Elevation stimulus prior&#xD;
      to playing the AlAn's Short Game v.2 is associated with differences in game behavior. The&#xD;
      study will also test whether psychopathic traits will correlate with game behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses and Specific Aims:&#xD;
&#xD;
      Aim 1: Examine the similarities and differences in behaviors on the AlAn's Short Game v.2&#xD;
      seen with the two Active Trial (AT) types (where Red Cross donation will be reduced and&#xD;
      subject will gain money (AT1) vs. where the Red Cross donation will increase and study&#xD;
      participants will lose money (AT2).&#xD;
&#xD;
      Hypothesis 1: Number of accepted trials of AT1 and AT2 from session 1 will significantly&#xD;
      correlate.&#xD;
&#xD;
      Aim 2: Test the effects of Elevation vs. Nature video on change in AlAn's Short Game v.2&#xD;
      behavior between sessions 1 and 2.&#xD;
&#xD;
      Hypothesis 2: Subjects who view the Elevation stimulus video (study Arm 1) will show&#xD;
      increases in prosocial behavior while those watching the Nature video will not.&#xD;
&#xD;
      Aim 3: Test the association between psychopathic traits and Costly Helping and determine&#xD;
      whether the influence of Elevation on Costly Helping dissipates with increasing levels of&#xD;
      psychopathic traits.&#xD;
&#xD;
      Hypothesis 3: Psychopathic traits, as measured by the Levenson Self Report Psychopathy Scale,&#xD;
      will significantly and negatively correlate with the amount of prosocial behavior in session&#xD;
      1.&#xD;
&#xD;
      Hypothesis 4: Using subjects from study Arm 1, change in AlAn's Short game v.2 behavior&#xD;
      (session 2 minus session 1) will be negatively correlated with psychopathic trait scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2019</start_date>
  <completion_date type="Actual">October 26, 2019</completion_date>
  <primary_completion_date type="Actual">October 26, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Study participants will be randomly assigned to receive one of two possible orders of administration. All subjects will first complete the Levenson Psychopathy Scale. Then Arm 1 presents the Moral Elevation stimulus after playing the first AlAn's Short Game v.2 (session 1), while Arm 2 presents the control stimulus (nature video). Subjects in both arms will then play AlAn's game again. After playing the game for a second time, subjects in both arms will fill out an Adverse Childhood Experiences Questionnaire (ACES), Social Connectedness survey, and Demographics form.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Amount of Prosocial Behavior on the AlAn's Short Game v.2</measure>
    <time_frame>within 45 minutes, during one single study visit</time_frame>
    <description>The primary outcome of interest is the change in the amount of prosocial behavior on the AlAn's Short game between sessions 1 and 2 (Costly Helping session 2 minus Costly Helping session 1).&#xD;
Our two main analyses of interest using this outcome measure are: (1) to test whether viewing the Moral Elevation stimulus video vs. the Control video experience a greater change in Costly Helping (e.g., that Moral Elevation response promotes prosocial behavior); and (2) to test whether psychopathic traits attenuate the relationship between Moral Elevation and prosocial behavior (i.e., among those viewing the Moral Elevation stimulus video, that our primary outcome - change in prosocial behavior - will be negatively related to level of psychopathic traits).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">537</enrollment>
  <condition>Psychopathic Personality Trait</condition>
  <arm_group>
    <arm_group_label>Arm 1 - Elevation Stimulus Video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects complete the Levenson Psychopathy Scale first. Arm 1 then presents the Moral Elevation stimulus video after playing the first AlAn's Short Game v.2 (session 1). Participants will then play the AlAn's Short Game v.2 (session 2) for a second time and then fill out an Adverse Childhood Experiences Questionnaire (ACES), Social Connectedness survey, and Demographics form.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 - Control Stimulus Video</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>All subjects complete the Levenson Psychopathy Scale first. Arm 2 then presents the control stimulus (nature video) after playing the first AlAn's Short Game v.2 (session 1). Participants will then play the AlAn's Short Game v.2 (session 2) for a second time and then fill out an Adverse Childhood Experiences Questionnaire (ACES), Social Connectedness survey, and Demographics form.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arm 1 - Elevation Stimulus Video</intervention_name>
    <description>Subjects will watch a video that has been shown in previous studies to elicit an elevation response. This video shows a news story about a man saving the life of another man who falls onto the subway tracks.</description>
    <arm_group_label>Arm 1 - Elevation Stimulus Video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arm 2 - Control Stimulus Video</intervention_name>
    <description>Subjects will watch a nature video.</description>
    <arm_group_label>Arm 2 - Control Stimulus Video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • age 18-25 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • refusal to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph T Sakai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Algoe SB, Haidt J. Witnessing excellence in action: the 'other-praising' emotions of elevation, gratitude, and admiration. J Posit Psychol. 2009;4(2):105-127. doi: 10.1080/17439760802650519.</citation>
    <PMID>19495425</PMID>
  </reference>
  <reference>
    <citation>Haidt J. Elevation and the positive psychology of morality. In: Keyes C, Haidt, J., editor. Flourishing: Positive psychology and the life well-lived. Washington, DC: American Psychological Association 913-919, 2003.</citation>
  </reference>
  <reference>
    <citation>Sakai JT, Dalwani MS, Mikulich-Gilbertson SK, McWilliams SK, Raymond KM, Crowley TJ. A Behavioral Measure of Costly Helping: Replicating and Extending the Association with Callous Unemotional Traits in Male Adolescents. PLoS One. 2016 Mar 15;11(3):e0151678. doi: 10.1371/journal.pone.0151678. eCollection 2016.</citation>
    <PMID>26977935</PMID>
  </reference>
  <reference>
    <citation>Aquino K, McFerran B, Laven M. Moral identity and the experience of moral elevation in response to acts of uncommon goodness. J Pers Soc Psychol. 2011 Apr;100(4):703-18. doi: 10.1037/a0022540.</citation>
    <PMID>21443375</PMID>
  </reference>
  <reference>
    <citation>Freeman D, Aquino K, McFerran B. Overcoming beneficiary race as an impediment to charitable donations: social dominance orientation, the experience of moral elevation, and donation behavior. Pers Soc Psychol Bull. 2009 Jan;35(1):72-84. doi: 10.1177/0146167208325415. Epub 2008 Nov 18.</citation>
    <PMID>19017786</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 17, 2020</last_update_submitted>
  <last_update_submitted_qc>March 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psychopathic traits</keyword>
  <keyword>moral elevation</keyword>
  <keyword>prosocial behavior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antisocial Personality Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not share individual participant data. We might print the results of this research study in relevant journals or share aggregate data on that does not identify subjects with qualified investigators or as a supplement as required by some journals. However, the names and any other identifying information of research subjects will always be kept confidential and will not be shared. The data that may be shared in this manner include gender, age, and race/ethnicity, as well as responses from the AlAn's Game v.2, Levenson Psychopathy Scale, adverse childhood experiences questionnaire and social connectedness survey.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03834467
org study id: 17-0182
nct id: NCT03834467
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It has been demonstrated that behavior on the AlAn's (altruism-antisocial) game is related to
      Moral Elevation response. Moral Elevation is a positive response to another's act of
      generosity "of charity, gratitude, fidelity, generosity or any other strong display of
      virtue". The constellation of emotional, physical and psychological aspects of a Moral
      Elevation response have been well described. Moral Elevation can be elicited with stimulus
      stories or videos and measured with self-report questionnaires. The experience of Moral
      Elevation is associated with subsequent prosocial and affiliative behaviors. Additionally,
      the research has linked Moral Elevation response with behavior on the AlAn's game. This study
      will test whether behavior on the AlAn's Short Game v.2 is related to Moral Elevation
      response and extend prior work by testing whether viewing the Moral Elevation stimulus prior
      to playing the AlAn's Short Game v.2 is associated with differences in game behavior. The
      study will also test whether psychopathic traits will correlate with game behavior.
Hypotheses and Specific Aims:

      Aim 1: Examine the similarities and differences in behaviors on the AlAn's Short Game v.2
      seen with the two Active Trial (AT) types (where Red Cross donation will be reduced and
      subject will gain money (AT1) vs. where the Red Cross donation will increase and study
      participants will lose money (AT2).

      Hypothesis 1: Number of accepted trials of AT1 and AT2 from session 1 will significantly
      correlate.

      Aim 2: Test the effects of Elevation vs. Nature video on change in AlAn's Short Game v.2
      behavior between sessions 1 and 2.

      Hypothesis 2: Subjects who view the Elevation stimulus video (study Arm 1) will show
      increases in prosocial behavior while those watching the Nature video will not.

      Aim 3: Test the association between psychopathic traits and Costly Helping and determine
      whether the influence of Elevation on Costly Helping dissipates with increasing levels of
      psychopathic traits.

      Hypothesis 3: Psychopathic traits, as measured by the Levenson Self Report Psychopathy Scale,
      will significantly and negatively correlate with the amount of prosocial behavior in session
      1.

      Hypothesis 4: Using subjects from study Arm 1, change in AlAn's Short game v.2 behavior
      (session 2 minus session 1) will be negatively correlated with psychopathic trait scores.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study participants will be randomly assigned to receive one of two possible orders of administration. All subjects will first complete the Levenson Psychopathy Scale. Then Arm 1 presents the Moral Elevation stimulus after playing the first AlAn's Short Game v.2 (session 1), while Arm 2 presents the control stimulus (nature video). Subjects in both arms will then play AlAn's game again. After playing the game for a second time, subjects in both arms will fill out an Adverse Childhood Experiences Questionnaire (ACES), Social Connectedness survey, and Demographics form.
primary purpose: Other
masking: None (Open Label)
measure: Change in the Amount of Prosocial Behavior on the AlAn's Short Game v.2
time frame: within 45 minutes, during one single study visit
description: The primary outcome of interest is the change in the amount of prosocial behavior on the AlAn's Short game between sessions 1 and 2 (Costly Helping session 2 minus Costly Helping session 1).
Our two main analyses of interest using this outcome measure are: (1) to test whether viewing the Moral Elevation stimulus video vs. the Control video experience a greater change in Costly Helping (e.g., that Moral Elevation response promotes prosocial behavior); and (2) to test whether psychopathic traits attenuate the relationship between Moral Elevation and prosocial behavior (i.e., among those viewing the Moral Elevation stimulus video, that our primary outcome - change in prosocial behavior - will be negatively related to level of psychopathic traits).
arm group label: Arm 1 - Elevation Stimulus Video
arm group type: Experimental
description: All subjects complete the Levenson Psychopathy Scale first. Arm 1 then presents the Moral Elevation stimulus video after playing the first AlAn's Short Game v.2 (session 1). Participants will then play the AlAn's Short Game v.2 (session 2) for a second time and then fill out an Adverse Childhood Experiences Questionnaire (ACES), Social Connectedness survey, and Demographics form.
arm group label: Arm 2 - Control Stimulus Video
arm group type: Sham Comparator
description: All subjects complete the Levenson Psychopathy Scale first. Arm 2 then presents the control stimulus (nature video) after playing the first AlAn's Short Game v.2 (session 1). Participants will then play the AlAn's Short Game v.2 (session 2) for a second time and then fill out an Adverse Childhood Experiences Questionnaire (ACES), Social Connectedness survey, and Demographics form.
intervention type: Other
intervention name: Arm 1 - Elevation Stimulus Video
description: Subjects will watch a video that has been shown in previous studies to elicit an elevation response. This video shows a news story about a man saving the life of another man who falls onto the subway tracks.
arm group label: Arm 1 - Elevation Stimulus Video
intervention type: Other
intervention name: Arm 2 - Control Stimulus Video
description: Subjects will watch a nature video.
arm group label: Arm 2 - Control Stimulus Video
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph T Sakai, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
citation: Algoe SB, Haidt J. Witnessing excellence in action: the 'other-praising' emotions of elevation, gratitude, and admiration. J Posit Psychol. 2009;4(2):105-127. doi: 10.1080/17439760802650519.
PMID: 19495425
citation: Haidt J. Elevation and the positive psychology of morality. In: Keyes C, Haidt, J., editor. Flourishing: Positive psychology and the life well-lived. Washington, DC: American Psychological Association 913-919, 2003.
citation: Sakai JT, Dalwani MS, Mikulich-Gilbertson SK, McWilliams SK, Raymond KM, Crowley TJ. A Behavioral Measure of Costly Helping: Replicating and Extending the Association with Callous Unemotional Traits in Male Adolescents. PLoS One. 2016 Mar 15;11(3):e0151678. doi: 10.1371/journal.pone.0151678. eCollection 2016.
PMID: 26977935
citation: Aquino K, McFerran B, Laven M. Moral identity and the experience of moral elevation in response to acts of uncommon goodness. J Pers Soc Psychol. 2011 Apr;100(4):703-18. doi: 10.1037/a0022540.
PMID: 21443375
citation: Freeman D, Aquino K, McFerran B. Overcoming beneficiary race as an impediment to charitable donations: social dominance orientation, the experience of moral elevation, and donation behavior. Pers Soc Psychol Bull. 2009 Jan;35(1):72-84. doi: 10.1177/0146167208325415. Epub 2008 Nov 18.
PMID: 19017786
responsible party type: Sponsor
mesh term: Antisocial Personality Disorder
sharing ipd: No
ipd description: We will not share individual participant data. We might print the results of this research study in relevant journals or share aggregate data on that does not identify subjects with qualified investigators or as a supplement as required by some journals. However, the names and any other identifying information of research subjects will always be kept confidential and will not be shared. The data that may be shared in this manner include gender, age, and race/ethnicity, as well as responses from the AlAn's Game v.2, Levenson Psychopathy Scale, adverse childhood experiences questionnaire and social connectedness survey.