xml: <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/NCT06038721</url>
    </required_header>
    <id_info>
      <org_study_id>20230860</org_study_id>
      <nct_id>NCT06038721</nct_id>
    </id_info>
    <brief_title>Unified Protocol: Community Connections</brief_title>
    <official_title>Unified Protocol: Community Connections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Children's Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Miami</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 administer the Unified Protocols for Transdiagnostic&#xD;
        Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A) to youth and&#xD;
        participants' parents and to examine the efficacy and outcomes of the treatment using&#xD;
        standardized measures, questionnaires, interviews. The UP-C and the UP-A are&#xD;
        cognitive-behavioral therapies to treat emotional disorders.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 25, 2023</start_date>
    <completion_date type="Anticipated">September 25, 2028</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2028</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-S)</measure>
      <time_frame>Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).</time_frame>
      <description>The Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-25) is 25-item parent-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite score ranging from 0 to 75. A score of 70 or higher indicates high severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)</measure>
      <time_frame>Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).</time_frame>
      <description>The Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-25) is 25-item self-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite scores ranging from 0 to 75. A score of 70 or higher indicates high severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Strengths and Difficulties Questionnaire - Parent Version (SDQ-P)</measure>
      <time_frame>Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).</time_frame>
      <description>The Strengths and Difficulties Questionnaire (SDQ) is a 25-item parent-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Strengths and Difficulties Questionnaire - Child Version (SDQ-C)</measure>
      <time_frame>Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).</time_frame>
      <description>The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total composite scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Parental Stress Scale (PSS) as measured by Likert Scale</measure>
      <time_frame>Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).</time_frame>
      <description>The Parental Stress Scale (PSS) is an 18-item measure assessing parents' feelings about their parenting role, exploring both positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, feelings of stress) aspects on parenthood. All items are rated on 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). Items are summed with higher scores indicating higher levels of parental stress.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Top Problems Assessment - Parent Report as measured by Likert Scale</measure>
      <time_frame>up to 24 weeks</time_frame>
      <description>The Top Problems assessment is used to identify parent-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Top Problems Assessment - Child Report as measured by Likert Scale</measure>
      <time_frame>up to 24 weeks</time_frame>
      <description>The Top Problems assessment is used to identify self-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Clinical Global Impression, Severity Scale (CGI-S)</measure>
      <time_frame>At baseline, and up to 24 weeks</time_frame>
      <description>The CGI-S is a single-item clinician-reported measure used to assess the severity of the youth's illness at the time of assessment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Global Impression - Improvement (CGI-I)</measure>
      <time_frame>At up to 24 weeks</time_frame>
      <description>The CGI-I is a single-item clinician-reported measure used to assess clinical changes in youth symptomology over the course of treatment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom improvement since baseline.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Mental Health Issue</condition>
    <condition>Anxiety Disorder</condition>
    <condition>Depressive Disorder</condition>
    <condition>Parenting</condition>
    <arm_group>
      <arm_group_label>The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in up to 15 sessions through a group format, attended over up to 24 weeks. Sessions will include parent and child strategies to manage strong emotions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in an individual format for up to 24 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children</intervention_name>
      <description>The UP-C is administered in-person to parents and children over the course of up to 15 weekly group sessions, which last approximately 90 minutes each.</description>
      <arm_group_label>The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children</arm_group_label>
      <other_name>UP-C</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents</intervention_name>
      <description>The UP-A is administered to parents and teens over the course of approximately 15-24 weekly individual sessions, which last approximately 50 minutes each. Sessions can be administered in-person or online, with at least one session occurring in person.</description>
      <arm_group_label>The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents</arm_group_label>
      <other_name>UP-A</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children between the ages of 7-17.&#xD;
  &#xD;
            -  Youth currently resides in Miami-Dade County.&#xD;
  &#xD;
            -  Children and their parents must be able to speak and understand English and/or Spanish&#xD;
               sufficiently well to complete study procedures (e.g., provide their informed&#xD;
               consent/assent, complete assessment measures and/or program materials).&#xD;
  &#xD;
            -  At least one parent or caregiver with whom the child is living with that can accompany&#xD;
               the child and participate in all visits (assessment and treatment).&#xD;
  &#xD;
            -  Positive endorsement of elevated emotional concerns in one of a limited range of&#xD;
               emotional disorder domains (i.e., anxiety, depression, trauma, or obsessive-compulsive&#xD;
               symptoms, etc.) during full DIAMOND-Kid semi-structured interview, and/or elevated&#xD;
               anxiety or depression symptoms (T-score &gt; or = 65) on the Revised Child Anxiety and&#xD;
               Depression Scale - Short Form (RCADS; Child or Parent Report).&#xD;
  &#xD;
            -  Youth with other types of comorbid conditions (e.g., tic/Tourette's disorder, eating&#xD;
               disorders, or disruptive behavior disorders) will not be excluded, providing a&#xD;
               clinical area of concern is regarding one of the emotional disorder domains specified&#xD;
               and treatment within this protocol is deemed most appropriate.&#xD;
  &#xD;
            -  Youth and parent participation in at least one in-person session if the treatment is&#xD;
               predominantly delivered virtually.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior receipt of at least 8 sessions of the UP-C/A program at the Child and Adolescent&#xD;
               Mood and Anxiety Treatment Program (CAMAT).&#xD;
  &#xD;
            -  Psychiatric hospitalization in the previous 6 months (i.e., due to Baker Act,&#xD;
               psychotic symptoms, significant suicidal ideation, danger to self or others, etc.).&#xD;
  &#xD;
            -  Another significant problem area that takes priority for services (e.g., eating&#xD;
               disorder, substance-use disorder, primary externalizing concerns, psychotic symptoms,&#xD;
               etc.), as identified by family report or via DIAMOND-Kid interview.&#xD;
  &#xD;
            -  Inability for family to wait for the next group treatment cohort to start, family&#xD;
               declining therapist assignment following intake, and/or family no-showing to 3 or more&#xD;
               scheduled sessions at CAMAT (inclusive of intake assessment).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jill Ehrenreich-May, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jill Ehrenreich-May, PhD</last_name>
      <phone>305-284-6476</phone>
      <email>j.ehrenreich@miami.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Niza Tonarely-Busto, PhD</last_name>
      <phone>305-284-2712</phone>
      <email>niza.tonarely@miami.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Child and Adolescent Mood and Anxiety Treatment Program</name>
        <address>
          <city>Coral Gables</city>
          <state>Florida</state>
          <zip>33146</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jill Ehrenreich-May, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Jill Ehrenreich-May, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Ehrenreich-May, J., Kennedy, S. M., Sherman, J. A., Bilek, E. L., Buzzella, B. A., Bennett, S. M., &amp; Barlow, D. H. (2017). Unified protocols for transdiagnostic treatment of emotional disorders in children and adolescents: Therapist guide. Oxford University Press.</citation>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Jill May Ehrenreich</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038721
  org study id: 20230860
  nct id: NCT06038721
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to administer the Unified Protocols for Transdiagnostic
        Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A) to youth and
        participants' parents and to examine the efficacy and outcomes of the treatment using
        standardized measures, questionnaires, interviews. The UP-C and the UP-A are
        cognitive-behavioral therapies to treat emotional disorders.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-S)
  time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
  description: The Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-25) is 25-item parent-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite score ranging from 0 to 75. A score of 70 or higher indicates high severity.
  measure: Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)
  time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
  description: The Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-25) is 25-item self-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite scores ranging from 0 to 75. A score of 70 or higher indicates high severity.
  measure: Change in Strengths and Difficulties Questionnaire - Parent Version (SDQ-P)
  time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
  description: The Strengths and Difficulties Questionnaire (SDQ) is a 25-item parent-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.
  measure: Change in Strengths and Difficulties Questionnaire - Child Version (SDQ-C)
  time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
  description: The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total composite scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.
  measure: Change in Parental Stress Scale (PSS) as measured by Likert Scale
  time frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
  description: The Parental Stress Scale (PSS) is an 18-item measure assessing parents' feelings about their parenting role, exploring both positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, feelings of stress) aspects on parenthood. All items are rated on 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). Items are summed with higher scores indicating higher levels of parental stress.
  measure: Top Problems Assessment - Parent Report as measured by Likert Scale
  time frame: up to 24 weeks
  description: The Top Problems assessment is used to identify parent-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).
  measure: Top Problems Assessment - Child Report as measured by Likert Scale
  time frame: up to 24 weeks
  description: The Top Problems assessment is used to identify self-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).
  measure: Change in Clinical Global Impression, Severity Scale (CGI-S)
  time frame: At baseline, and up to 24 weeks
  description: The CGI-S is a single-item clinician-reported measure used to assess the severity of the youth's illness at the time of assessment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom severity.
  measure: Clinical Global Impression - Improvement (CGI-I)
  time frame: At up to 24 weeks
  description: The CGI-I is a single-item clinician-reported measure used to assess clinical changes in youth symptomology over the course of treatment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom improvement since baseline.
  arm group label: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
  arm group type: Experimental
  description: The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in up to 15 sessions through a group format, attended over up to 24 weeks. Sessions will include parent and child strategies to manage strong emotions.
  arm group label: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
  arm group type: Experimental
  description: The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in an individual format for up to 24 weeks.
  intervention type: Behavioral
  intervention name: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
  description: The UP-C is administered in-person to parents and children over the course of up to 15 weekly group sessions, which last approximately 90 minutes each.
  arm group label: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
  other name: UP-C
  intervention type: Behavioral
  intervention name: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
  description: The UP-A is administered to parents and teens over the course of approximately 15-24 weekly individual sessions, which last approximately 50 minutes each. Sessions can be administered in-person or online, with at least one session occurring in person.
  arm group label: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
  other name: UP-A
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Jill Ehrenreich-May, PhD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Jill Ehrenreich-May, PhD
  phone: 305-284-6476
  email: j.ehrenreich@miami.edu
  last name: Niza Tonarely-Busto, PhD
  phone: 305-284-2712
  email: niza.tonarely@miami.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: Ehrenreich-May, J., Kennedy, S. M., Sherman, J. A., Bilek, E. L., Buzzella, B. A., Bennett, S. M., & Barlow, D. H. (2017). Unified protocols for transdiagnostic treatment of emotional disorders in children and adolescents: Therapist guide. Oxford University Press.
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Jill May Ehrenreich
  investigator title: Professor
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders
  sharing ipd: No