<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/NCT04450641</url>
  </required_header>
  <id_info>
    <org_study_id>39562</org_study_id>
    <nct_id>NCT04450641</nct_id>
  </id_info>
  <brief_title>Piloting a Mobile Game for Behavioral Therapy</brief_title>
  <official_title>A Gamified Mobile Platform for Improving Social Communication in Children With Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      The following study aims to understand the feasibility of the mobile app and game, GuessWhat,&#xD;
      to deliver behavioral therapy to children with autism. The GuessWhat app is a charades style&#xD;
      game that engages parent and child in fluid social interaction where the parent must guess&#xD;
      what the child is acting out based on the prompt shown on the phone screen. Participants will&#xD;
      use their own personal phone to download the study app. The app will walk participants&#xD;
      through a variety of charades style games. The interactive games will be video recorded and&#xD;
      all data are transferred securely to the Wall Lab for analysis. This study is enrolling&#xD;
      parents of children with ASD who are at least 18 years of age and have a child between 3-12&#xD;
      years old. Parents are asked to complete questionnaires before and after playing the&#xD;
      GuessWhat game with their child 3-4 times per week for 4 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All participants who complete baseline measures will be directed to download the GuessWhat app. Participants who do not download the GuessWhat app and elect not to play, will be assigned to the Inactive Users group during analysis.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking. All participants received the same condition and asked to play a mobile app. Participants who did not play the app during piloting were asked to complete study measures pre and post. These measures were compared against participants who did play the app.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in parent reported social responsiveness from week 0 to week 4</measure>
    <time_frame>Baseline (Week 0), Week 4</time_frame>
    <description>The Social Responsiveness Scale-2 is a 65-item measure where parents rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severitySocial Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4</measure>
    <time_frame>Baseline (Week 0), Week 4</time_frame>
    <description>Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Socialization subscale of the Parent/Caregiver Comprehensive form will be administered online to the parents. Scores from the socialization domain of the VABS-III reflects one's functioning in social situations. The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GuessWhat App Usage Data</measure>
    <time_frame>4 weeks</time_frame>
    <description>App usage data comprised of game decks selected, number of game sessions started, ended, and shared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent reported feedback</measure>
    <time_frame>Week 4</time_frame>
    <description>Qualitative survey delivered to parent participants at Week 4 to understand preferred games, overall feedback including likes and dislikes, any technical issues they experienced or challenges in using the app.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parent reported communication subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4</measure>
    <time_frame>Baseline (Week 0), Week 4</time_frame>
    <description>Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Communication subscale of the Parent/Caregiver Comprehensive form will be administered online to the parents. Scores from the communication domain of the VABS-III reflects The communication subscale is 32 items, where raw scores are converted to IQ-type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Baseline Parent Reported Social Communication</measure>
    <time_frame>Baseline (Week 0)</time_frame>
    <description>The Social Communication Questionnaire (SCQ) screens for autism in children over 4:0 years in age. Parents are asked 40 Yes/No questions and the resulting score is out of 39 (the first question is not associated with a numerical value). The SCQ assesses a child's communication skills and social functioning. It takes less than 10 minutes to complete and is administered by clinical research coordinators to parents of children during the phone screen to participants who have already completed the online screening questionnaire. A score of 15 or above is indicative of autism and is required to be eligible in the research study.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment group used GuessWhat during the 4 week intervention period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in control group received standard treatment as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GuessWhat Mobile Application</intervention_name>
    <description>The GuessWhat app is a charades style game and app that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. Parent and child will be encouraged to play using the emojis and emotion game mode at least 3 individual game sessions per week. Parents are asked to play GuessWhat with their child 3-4 times per week for 4 weeks.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent who is at least 18 years old of child with autism.&#xD;
&#xD;
          -  Child with autism is between 3 and 12 years old at time of baseline data collection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent is not able to read or speak English&#xD;
&#xD;
          -  Parent does not have an Android or iOs smartphone compatible with GuessWhat App&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis P Wall, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://guesswhat.stanford.edu</url>
    <description>Study Website</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Dennis Paul Wall</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>digital</keyword>
  <keyword>mobile health</keyword>
  <keyword>game</keyword>
  <keyword>autism</keyword>
  <keyword>technology</keyword>
  <keyword>therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04450641
org study id: 39562
nct id: NCT04450641
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The following study aims to understand the feasibility of the mobile app and game, GuessWhat,
      to deliver behavioral therapy to children with autism. The GuessWhat app is a charades style
      game that engages parent and child in fluid social interaction where the parent must guess
      what the child is acting out based on the prompt shown on the phone screen. Participants will
      use their own personal phone to download the study app. The app will walk participants
      through a variety of charades style games. The interactive games will be video recorded and
      all data are transferred securely to the Wall Lab for analysis. This study is enrolling
      parents of children with ASD who are at least 18 years of age and have a child between 3-12
      years old. Parents are asked to complete questionnaires before and after playing the
      GuessWhat game with their child 3-4 times per week for 4 weeks.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: All participants who complete baseline measures will be directed to download the GuessWhat app. Participants who do not download the GuessWhat app and elect not to play, will be assigned to the Inactive Users group during analysis.
primary purpose: Other
masking: None (Open Label)
masking description: No masking. All participants received the same condition and asked to play a mobile app. Participants who did not play the app during piloting were asked to complete study measures pre and post. These measures were compared against participants who did play the app.
measure: Change in parent reported social responsiveness from week 0 to week 4
time frame: Baseline (Week 0), Week 4
description: The Social Responsiveness Scale-2 is a 65-item measure where parents rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severitySocial Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).
measure: Change in parent reported socialization subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
time frame: Baseline (Week 0), Week 4
description: Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Socialization subscale of the Parent/Caregiver Comprehensive form will be administered online to the parents. Scores from the socialization domain of the VABS-III reflects one's functioning in social situations. The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.
measure: GuessWhat App Usage Data
time frame: 4 weeks
description: App usage data comprised of game decks selected, number of game sessions started, ended, and shared.
measure: Parent reported feedback
time frame: Week 4
description: Qualitative survey delivered to parent participants at Week 4 to understand preferred games, overall feedback including likes and dislikes, any technical issues they experienced or challenges in using the app.
measure: Change in parent reported communication subscale scores of the Vineland Adaptive Behavior Scales,2nd Edition (VABS-II) from baseline to week 4
time frame: Baseline (Week 0), Week 4
description: Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Communication subscale of the Parent/Caregiver Comprehensive form will be administered online to the parents. Scores from the communication domain of the VABS-III reflects The communication subscale is 32 items, where raw scores are converted to IQ-type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.
measure: Baseline Parent Reported Social Communication
time frame: Baseline (Week 0)
description: The Social Communication Questionnaire (SCQ) screens for autism in children over 4:0 years in age. Parents are asked 40 Yes/No questions and the resulting score is out of 39 (the first question is not associated with a numerical value). The SCQ assesses a child's communication skills and social functioning. It takes less than 10 minutes to complete and is administered by clinical research coordinators to parents of children during the phone screen to participants who have already completed the online screening questionnaire. A score of 15 or above is indicative of autism and is required to be eligible in the research study.
arm group label: Treatment
arm group type: Experimental
description: Treatment group used GuessWhat during the 4 week intervention period.
arm group label: Control
arm group type: Other
description: Participants in control group received standard treatment as usual.
intervention type: Other
intervention name: GuessWhat Mobile Application
description: The GuessWhat app is a charades style game and app that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. Parent and child will be encouraged to play using the emojis and emotion game mode at least 3 individual game sessions per week. Parents are asked to play GuessWhat with their child 3-4 times per week for 4 weeks.
arm group label: Control
arm group label: Treatment
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dennis P Wall, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
url: http://guesswhat.stanford.edu
description: Study Website
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Dennis Paul Wall
investigator title: Associate Professor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No