<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/NCT03019952</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00003849</org_study_id>
    <nct_id>NCT03019952</nct_id>
  </id_info>
  <brief_title>Effectiveness of the Care Coordination, Assessment, and Responsive Engagement Program for Transition-aged Adolescents (t-CARE) With ASD</brief_title>
  <acronym>t-CARE</acronym>
  <official_title>Effectiveness of the Care Coordination, Assessment, and Responsive Engagement Program for Transition-aged Adolescents (t-CARE) With ASD</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>
      An analysis of data for adolescents and young adults diagnosed with Autism Spectrum Disorders&#xD;
      (ASDs) who are evaluated as part of the Care Coordination, Assessment, and Responsive&#xD;
      Engagement for transition-aged adolescents (t-CARE) program which replaced the former Autism&#xD;
      Life Care Model (ALCM), which was a clinical program implemented between Fall 2014 and April&#xD;
      2016. The individuals enrolled in the program will be administered a standardized assessment&#xD;
      battery during each visit with the care coordinator or study coordinator. The proposed study&#xD;
      will analyze data gathered during each of the assessment periods in order to check the&#xD;
      efficacy and viability of the protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current collaboration between individuals, families, and providers through in-person meetings&#xD;
      are extremely infrequent, costly, and occur most often when providers are intimately involved&#xD;
      as part of a multidisciplinary team in a single setting such as at a school. Often, little&#xD;
      information is transmitted between providers and/or school personnel in determining treatment&#xD;
      goals and interventions. Furthermore, the transmission of information is often provider to&#xD;
      provider or school personnel to provider, which excludes direct patient-input and lessens&#xD;
      transparency in decision making. In an effort to improve current care and therefore improve&#xD;
      successful adult transitions for adolescents with ASD, t-CARE is designed to mimic&#xD;
      multidisciplinary team meetings. These meetings are incredibly impactful as they include&#xD;
      direct individual and family involvement through facilitated information-sharing, while also&#xD;
      maintaining patient-centered care across multiple providers and complex systems of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">April 9, 2018</completion_date>
  <primary_completion_date type="Actual">April 9, 2018</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>Holmes and Rahe Stress Scale</measure>
    <time_frame>annually over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>SRS-2</measure>
    <time_frame>annually over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Waisman Activities of Daily Living Scale</measure>
    <time_frame>annually over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Intolerance of Uncertainty</measure>
    <time_frame>annually over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS Multi-Domain 49</measure>
    <time_frame>monthly over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Temple University Community Participation (TUCP) measure</measure>
    <time_frame>quarterly over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS proxy measures</measure>
    <time_frame>quarterly over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PROMIS SF measures</measure>
    <time_frame>monthly over 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-Determination Scale</measure>
    <time_frame>annually over 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Closure Survey</measure>
    <time_frame>after completion of 2 year study</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">52</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care Coordination Visit</intervention_name>
    <description>This is a longitudinal study. Adolescents or young adults with autism will participate in this study. Participants will be required to complete a baseline of assessment measures at enrollment and then monthly assessments (described in the study procedures below) during the first (approximately) 10-15 minutes of each visit with the t-CARE coordinator. The remainder of the visit will focus on care coordination and clinical treatment goals.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between 14 and 19 years of age upon entry into t-CARE&#xD;
&#xD;
          2. A primary diagnosis of Asperger's Syndrome or autism, as indicated by the Social&#xD;
             Responsiveness Scale, Second Edition (SRS-2; Constantino &amp; Gruber, 2012)&#xD;
&#xD;
          3. English as primary language spoken&#xD;
&#xD;
          4. Ability to self-report (i.e. understand and answer assessment questions written at a&#xD;
             third grade comprehension level) (self-report questions to be asked by study&#xD;
             coordinator)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A significant language delay&#xD;
&#xD;
          2. Significant psychosis as indicated through a semi-structured interview&#xD;
             (Mini-International Neuropsychiatric Interview)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>March 2019</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>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</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>
  <!-- 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/NCT03019952
org study id: STUDY00003849
nct id: NCT03019952
lead sponsor: 
collaborator: 
has dmc: No
An analysis of data for adolescents and young adults diagnosed with Autism Spectrum Disorders
      (ASDs) who are evaluated as part of the Care Coordination, Assessment, and Responsive
      Engagement for transition-aged adolescents (t-CARE) program which replaced the former Autism
      Life Care Model (ALCM), which was a clinical program implemented between Fall 2014 and April
      2016. The individuals enrolled in the program will be administered a standardized assessment
      battery during each visit with the care coordinator or study coordinator. The proposed study
      will analyze data gathered during each of the assessment periods in order to check the
      efficacy and viability of the protocol.
Current collaboration between individuals, families, and providers through in-person meetings
      are extremely infrequent, costly, and occur most often when providers are intimately involved
      as part of a multidisciplinary team in a single setting such as at a school. Often, little
      information is transmitted between providers and/or school personnel in determining treatment
      goals and interventions. Furthermore, the transmission of information is often provider to
      provider or school personnel to provider, which excludes direct patient-input and lessens
      transparency in decision making. In an effort to improve current care and therefore improve
      successful adult transitions for adolescents with ASD, t-CARE is designed to mimic
      multidisciplinary team meetings. These meetings are incredibly impactful as they include
      direct individual and family involvement through facilitated information-sharing, while also
      maintaining patient-centered care across multiple providers and complex systems of care.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Holmes and Rahe Stress Scale
time frame: annually over 2 years
measure: SRS-2
time frame: annually over 2 years
measure: Waisman Activities of Daily Living Scale
time frame: annually over 2 years
measure: Intolerance of Uncertainty
time frame: annually over 2 years
measure: PROMIS Multi-Domain 49
time frame: monthly over 2 years
measure: Temple University Community Participation (TUCP) measure
time frame: quarterly over 2 years
measure: PROMIS proxy measures
time frame: quarterly over 2 years
measure: PROMIS SF measures
time frame: monthly over 2 years
measure: Self-Determination Scale
time frame: annually over 2 years
measure: Closure Survey
time frame: after completion of 2 year study
intervention type: Behavioral
intervention name: Care Coordination Visit
description: This is a longitudinal study. Adolescents or young adults with autism will participate in this study. Participants will be required to complete a baseline of assessment measures at enrollment and then monthly assessments (described in the study procedures below) during the first (approximately) 10-15 minutes of each visit with the t-CARE coordinator. The remainder of the visit will focus on care coordination and clinical treatment goals.
criteria: 
gender: All
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
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