<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/NCT04460677</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2020001593</org_study_id>
    <nct_id>NCT04460677</nct_id>
  </id_info>
  <brief_title>ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19</brief_title>
  <official_title>ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</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 purpose of this study is to evaluate the feasibility, acceptability and effectiveness of&#xD;
      a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic&#xD;
      adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The&#xD;
      first objective is to develop and refine a brief telehealth-delivered treatment, the&#xD;
      Emotional Support Plan (ESP), to help promote adults to cope during periods of acute&#xD;
      distress, such as those experienced during the COVID-19 pandemic. The second objective is to&#xD;
      assess the feasibility and effectiveness of the ESP to support autistic adults to implement&#xD;
      emotion regulation strategies during periods of acute distress. The last objective is to&#xD;
      yield preliminary data to apply for extramural grants to validate these methods to monitor&#xD;
      and support mental health of autistic adults during key transitions (e.g., starting college).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Actual">February 9, 2022</completion_date>
  <primary_completion_date type="Actual">February 9, 2022</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decreased distress on Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>8 week study period</time_frame>
    <description>The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day) scale. Higher scores equal more distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decreased distress on EMA reports</measure>
    <time_frame>8 week study period</time_frame>
    <description>EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)</measure>
    <time_frame>8 week study period</time_frame>
    <description>The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day) scale. Higher scores equal more anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adult Self Report (ASR)</measure>
    <time_frame>8 week study period</time_frame>
    <description>The ASR is a measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Psychological Distress</condition>
  <condition>Stress, Psychological</condition>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Emotional Support Plan (ESP) + Weekly Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This will involve weekly assessments without prompting to use the plan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Emotional Support Plan (ESP) + 4x Daily Monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will be prompted on their phones 4x/day randomly, to report on activities, mood, suicidal ideation, distress level and ESP use since the last prompt</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Emotional Support Plan</intervention_name>
    <description>The Emotional Support Plan (ESP) is designed to help adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic.</description>
    <arm_group_label>Emotional Support Plan (ESP) + 4x Daily Monitoring</arm_group_label>
    <arm_group_label>Emotional Support Plan (ESP) + Weekly Monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Daily Monitoring</intervention_name>
    <description>The daily monitoring will remind participants 4x/day to report on their mood, distress, etc. and use their ESP if needed.</description>
    <arm_group_label>Emotional Support Plan (ESP) + 4x Daily Monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria Adults 18 years or older with previously established diagnoses in ASD&#xD;
        will be invited to participate. Adults who have a verbal IQ above 70 or who are students&#xD;
        admitted to a college or university will be included in the study.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Individuals who are younger than 18 years old or who does not have diagnosis of ASD&#xD;
             will excluded from the study as the purpose of the current research is to evaluate the&#xD;
             validity of ESPs in adults with autism.&#xD;
&#xD;
          -  Adults who are unable to understand English will be excluded because the instruments&#xD;
             being investigated are currently only validated in English and the study team is not&#xD;
             sufficiently fluent in other languages to provide assurance that informed consent&#xD;
             could be obtained (or intervention provided) in a language besides English.&#xD;
&#xD;
          -  Subjects without access to a compatible iOS and Android smartphone (nearly all phones&#xD;
             from the past 10 years are compatible) will be excluded because the study requires&#xD;
             subjects to record responses on a smartphone app. Individuals will not be excluded&#xD;
             from the study based on race, ethnicity or gender.&#xD;
&#xD;
          -  Subjects who have a verbal IQ below 70 will be excluded as this is a study that&#xD;
             requires self-report and engagement in a one-on-one intervention.&#xD;
&#xD;
          -  If the PI's clinical judgment is that it would not be in the adult's best interest to&#xD;
             be enrolled, they may also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rutgers University</name>
      <address>
        <city>Piscataway</city>
        <state>New Jersey</state>
        <zip>08854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 9, 2022</last_update_submitted>
  <last_update_submitted_qc>August 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Vanessa H. Bal, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>smartphone</keyword>
  <keyword>ecological momentary intervention (EMI)</keyword>
  <keyword>ecological momentary assessment (EMA)</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>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
    <mesh_term>Stress, Psychological</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/NCT04460677
org study id: Pro2020001593
nct id: NCT04460677
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of
      a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic
      adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The
      first objective is to develop and refine a brief telehealth-delivered treatment, the
      Emotional Support Plan (ESP), to help promote adults to cope during periods of acute
      distress, such as those experienced during the COVID-19 pandemic. The second objective is to
      assess the feasibility and effectiveness of the ESP to support autistic adults to implement
      emotion regulation strategies during periods of acute distress. The last objective is to
      yield preliminary data to apply for extramural grants to validate these methods to monitor
      and support mental health of autistic adults during key transitions (e.g., starting college).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Decreased distress on Patient Health Questionnaire (PHQ-9)
time frame: 8 week study period
description: The PHQ-9, assessed weekly, is a 9-item questionnaire of psychological function over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more distress.
measure: Decreased distress on EMA reports
time frame: 8 week study period
description: EMA (Ecological Momentary Assessment) reports of decreased distress (in ESP + daily monitoring group only). Higher scores on the item equal higher levels of distress.
measure: Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7)
time frame: 8 week study period
description: The GAD-7, assessed weekly, is a 7-item questionnaire of anxiety symptoms over the past week with all items on a "0" (not at all) to "3" (nearly every day) scale. Higher scores equal more anxiety.
measure: Adult Self Report (ASR)
time frame: 8 week study period
description: The ASR is a measure of adaptive functioning and psychopathology (e.g., anxiety, depression symptoms). Most of the items are on a 3 point scale including: (0) Not true, (1) Somewhat or sometimes true, and (2) Very often or often true.
arm group label: Emotional Support Plan (ESP) + Weekly Monitoring
arm group type: Experimental
description: This will involve weekly assessments without prompting to use the plan.
arm group label: Emotional Support Plan (ESP) + 4x Daily Monitoring
arm group type: Experimental
description: Participants in this arm will be prompted on their phones 4x/day randomly, to report on activities, mood, suicidal ideation, distress level and ESP use since the last prompt
intervention type: Behavioral
intervention name: Emotional Support Plan
description: The Emotional Support Plan (ESP) is designed to help adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic.
arm group label: Emotional Support Plan (ESP) + 4x Daily Monitoring
arm group label: Emotional Support Plan (ESP) + Weekly Monitoring
intervention type: Behavioral
intervention name: Daily Monitoring
description: The daily monitoring will remind participants 4x/day to report on their mood, distress, etc. and use their ESP if needed.
arm group label: Emotional Support Plan (ESP) + 4x Daily Monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Vanessa H. Bal, PhD
investigator title: Assistant Professor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
mesh term: Stress, Psychological
sharing ipd: No