<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/NCT02245607</url>
  </required_header>
  <id_info>
    <org_study_id>MH105247</org_study_id>
    <secondary_id>5R34MH105247-03</secondary_id>
    <nct_id>NCT02245607</nct_id>
  </id_info>
  <brief_title>Compensatory Cognitive Training in Clinical High Risk Latino Youth</brief_title>
  <official_title>Compensatory Cognitive Training in Clinical High Risk Latino Youth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized study to compare Compensatory Cognitive Training (CCT) versus&#xD;
      Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.&#xD;
&#xD;
      Study hypotheses: Compared to those who receive RT, study participants receiving CCT will&#xD;
      show significant improvement in neurocognition, functional capacity, self-rated functioning&#xD;
      and clinical measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 12 week randomized study to compare Compensatory Cognitive Training (CCT) versus&#xD;
      Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.&#xD;
&#xD;
      Study participants will be measured 3 times, at baseline, 12 and 24 weeks on all outcome&#xD;
      measures. Study hypothesis: Study participants receiving CCT will show significant&#xD;
      improvement at 12 and 24 weeks compared to baseline in 1) Neurocognition using the Global&#xD;
      Cognitive Index z score derived from the MATRICS neurocognitive domain scores, 2) Functional&#xD;
      Capacity as assessed by the UCSD Performance-based Skills Assessment (UPSA/UPSA-Adolescent),&#xD;
      3) Self-Rated Functioning as measured by the Specific Level of Functioning Scale (SLoF) and&#xD;
      4) Clinical symptom ratings as measured by the Scale of Prodromal Symptoms (SOPS) total score&#xD;
      when compared to subjects receiving RT training across study time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neurocognition (Global Cognitive Index z score)</measure>
    <time_frame>3 and 6 months post-baseline</time_frame>
    <description>The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional capacity (UPSA/UPSA-A)</measure>
    <time_frame>3 and 6 month post-baseline</time_frame>
    <description>The UPSA total Functional Capacity score is the total of all subscale scores on the UPSA (Finances, Communication, Transportation, Household)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-reported functioning (SLoF)</measure>
    <time_frame>3 and 6 month post-baseline</time_frame>
    <description>The specific level of functioning (SLOF) assessment scale measures observable behavioral functioning and daily living skills.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical symptom severity (SOPS total)</measure>
    <time_frame>3 and 6 month post-baseline</time_frame>
    <description>The Scale of Prodromal Symptoms (SOPS) measures positive, negative, disorganized and general symptoms seen in psychotic illness. The total score is used for outcome.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Clinical High Risk</condition>
  <condition>Psychosis</condition>
  <condition>Prodromal</condition>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Compensatory Cognitive Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Compensatory Cognitive Training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recreational Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Recreational Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Compensatory Cognitive Training</intervention_name>
    <arm_group_label>Compensatory Cognitive Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Recreational Therapy</intervention_name>
    <arm_group_label>Recreational Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet Clinical High Risk criteria&#xD;
&#xD;
          -  Be of Latino descent&#xD;
&#xD;
          -  Speak Spanish as their preferred language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant medical or neurological illness&#xD;
&#xD;
          -  Brain injury with loss of consciousness &gt; 30 minutes&#xD;
&#xD;
          -  Current substance abuse (excluding nicotine)&#xD;
&#xD;
          -  IQ &lt; 80&#xD;
&#xD;
          -  High suicidal risk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Cadenhead, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Neurología y Neurocirugía</name>
      <address>
        <city>Mexico City</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Kristin Cadenhead, M.D.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Psychotic Disorders</keyword>
  <keyword>Cognitive Training</keyword>
  <keyword>Mental Disorders</keyword>
  <keyword>Schizophrenia and Disorders with Psychotic Features</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</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/NCT02245607
org study id: MH105247
secondary id: 5R34MH105247-03
nct id: NCT02245607
lead sponsor: 
collaborator: 
has dmc: Yes
This is a randomized study to compare Compensatory Cognitive Training (CCT) versus
      Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.

      Study hypotheses: Compared to those who receive RT, study participants receiving CCT will
      show significant improvement in neurocognition, functional capacity, self-rated functioning
      and clinical measures.
This is a 12 week randomized study to compare Compensatory Cognitive Training (CCT) versus
      Recreational Therapy (RT) in Latino clinical high risk individuals in the US and Mexico.

      Study participants will be measured 3 times, at baseline, 12 and 24 weeks on all outcome
      measures. Study hypothesis: Study participants receiving CCT will show significant
      improvement at 12 and 24 weeks compared to baseline in 1) Neurocognition using the Global
      Cognitive Index z score derived from the MATRICS neurocognitive domain scores, 2) Functional
      Capacity as assessed by the UCSD Performance-based Skills Assessment (UPSA/UPSA-Adolescent),
      3) Self-Rated Functioning as measured by the Specific Level of Functioning Scale (SLoF) and
      4) Clinical symptom ratings as measured by the Scale of Prodromal Symptoms (SOPS) total score
      when compared to subjects receiving RT training across study time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Neurocognition (Global Cognitive Index z score)
time frame: 3 and 6 months post-baseline
description: The CGI is derived based on Z scores across multiple neurocognitive domains and is a representation of global cognition
measure: Functional capacity (UPSA/UPSA-A)
time frame: 3 and 6 month post-baseline
description: The UPSA total Functional Capacity score is the total of all subscale scores on the UPSA (Finances, Communication, Transportation, Household)
measure: Self-reported functioning (SLoF)
time frame: 3 and 6 month post-baseline
description: The specific level of functioning (SLOF) assessment scale measures observable behavioral functioning and daily living skills.
measure: Clinical symptom severity (SOPS total)
time frame: 3 and 6 month post-baseline
description: The Scale of Prodromal Symptoms (SOPS) measures positive, negative, disorganized and general symptoms seen in psychotic illness. The total score is used for outcome.
arm group label: Compensatory Cognitive Training
arm group type: Experimental
description: Compensatory Cognitive Training
arm group label: Recreational Therapy
arm group type: Active Comparator
description: Recreational Therapy
intervention type: Behavioral
intervention name: Compensatory Cognitive Training
arm group label: Compensatory Cognitive Training
intervention type: Behavioral
intervention name: Recreational Therapy
arm group label: Recreational Therapy
criteria: 
gender: All
minimum age: 12 Years
maximum age: 30 Years
healthy volunteers: No
last name: Kristin Cadenhead, MD
role: Principal Investigator
affiliation: University of California, San Diego
facility: 
facility: 
country: Mexico
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Kristin Cadenhead, M.D.
investigator title: Professor
mesh term: Schizophrenia