<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/NCT03019978</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004326</org_study_id>
    <nct_id>NCT03019978</nct_id>
  </id_info>
  <brief_title>Person-Centered Assessment and Monitoring Systems</brief_title>
  <acronym>PCAMS</acronym>
  <official_title>Person-Centered Assessment and Monitoring Systems (PCAMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pennsylvania Bureau of Autism Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will include an analysis of data for residents of Pennsylvania who are age&#xD;
      21 and older, have a diagnosis of Autism Spectrum Disorder (ASD), and are enrolled in the&#xD;
      Commonwealth's Adult Community Autism Program (ACAP). The individuals enrolled in the program&#xD;
      will be administered a standardized assessment battery quarterly for two years. The proposed&#xD;
      study will analyze the data gathered during each of the assessment periods in order to aid in&#xD;
      service/treatment planning, assess for individual improvements, and ultimately measure&#xD;
      treatment outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study seeks to more closely monitor the changing needs and challenges of adults&#xD;
      with ASD, which will be facilitated through a battery of assessments given over quarterly&#xD;
      time points in a two year time period. Investigators seek to address whether increased&#xD;
      frequency of behaviorally driven assessments will inform treatment. More specifically,&#xD;
      investigators are interested in knowing if the assessment data influences treatment planning&#xD;
      with providers or if it is guiding any decisions about treatment once data is returned to&#xD;
      participants in a meaningful way which is easily understood. If data prompts treatment&#xD;
      changes, the study will examine whether improvements are being shown months or even years&#xD;
      later.&#xD;
&#xD;
      An &quot;elected reporter&quot;, a family member, is asked to take part in the research study with the&#xD;
      participant. An elected reporter is asked to complete several questionnaires quarterly, both&#xD;
      reporting on themself and the participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Social Responsiveness Scale- 2</measure>
    <time_frame>annually over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adult Behavior Checklist</measure>
    <time_frame>annually over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Additional PROMIS measures</measure>
    <time_frame>quarterly over 2 years</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Community Engagement measure</measure>
    <time_frame>semi-annually over 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PROMIS measures</measure>
    <time_frame>quarterly over 2 years</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elected Reporter Community Engagement measure</measure>
    <time_frame>semi-annually over 2 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PCAMS assessments</intervention_name>
    <description>This is a longitudinal study, where data will be collected from 54 individuals who are already enrolled in Pennsylvania's ACAP program. Participants will be required to complete online assessments at baseline and then quarterly over a two-year time period.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in Pennsylvania's Adult Community Autism Program (ACAP), &gt; 18 years of age&#xD;
&#xD;
          -  English as primary language spoken&#xD;
&#xD;
          -  Ability to self-report (i.e. understand and answer assessment questions written at a&#xD;
             third grade comprehension level)&#xD;
&#xD;
          -  Have an Elected Reporter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Inability to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Murray, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hershey Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Penn State College of Medicine</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Michael Murray</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03019978
org study id: STUDY00004326
nct id: NCT03019978
lead sponsor: 
collaborator: 
has dmc: No
The proposed study will include an analysis of data for residents of Pennsylvania who are age
      21 and older, have a diagnosis of Autism Spectrum Disorder (ASD), and are enrolled in the
      Commonwealth's Adult Community Autism Program (ACAP). The individuals enrolled in the program
      will be administered a standardized assessment battery quarterly for two years. The proposed
      study will analyze the data gathered during each of the assessment periods in order to aid in
      service/treatment planning, assess for individual improvements, and ultimately measure
      treatment outcomes.
The proposed study seeks to more closely monitor the changing needs and challenges of adults
      with ASD, which will be facilitated through a battery of assessments given over quarterly
      time points in a two year time period. Investigators seek to address whether increased
      frequency of behaviorally driven assessments will inform treatment. More specifically,
      investigators are interested in knowing if the assessment data influences treatment planning
      with providers or if it is guiding any decisions about treatment once data is returned to
      participants in a meaningful way which is easily understood. If data prompts treatment
      changes, the study will examine whether improvements are being shown months or even years
      later.

      An "elected reporter", a family member, is asked to take part in the research study with the
      participant. An elected reporter is asked to complete several questionnaires quarterly, both
      reporting on themself and the participant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Social Responsiveness Scale- 2
time frame: annually over 2 years
measure: Adult Behavior Checklist
time frame: annually over 2 years
measure: Additional PROMIS measures
time frame: quarterly over 2 years
description: Patient-Reported Outcomes Measurement Information System
measure: Community Engagement measure
time frame: semi-annually over 2 years
measure: PROMIS measures
time frame: quarterly over 2 years
description: Patient-Reported Outcomes Measurement Information System
measure: Elected Reporter Community Engagement measure
time frame: semi-annually over 2 years
intervention type: Other
intervention name: PCAMS assessments
description: This is a longitudinal study, where data will be collected from 54 individuals who are already enrolled in Pennsylvania's ACAP program. Participants will be required to complete online assessments at baseline and then quarterly over a two-year time period.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael J Murray, M.D.
role: Principal Investigator
affiliation: Hershey Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Michael Murray
investigator title: Associate Professor of Psychiatry
mesh term: Autism Spectrum Disorder
sharing ipd: No