<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/NCT03800303</url>
  </required_header>
  <id_info>
    <org_study_id>17-010831</org_study_id>
    <nct_id>NCT03800303</nct_id>
  </id_info>
  <brief_title>Integrated Treatment for Youth With Mood Disorders</brief_title>
  <official_title>Healthy Youth &amp; Families: An Integrated Approach to Treating Mood Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      In an effort to understand the effects of evidence-based interventions on children and&#xD;
      adolescents, the aims of this study are to:&#xD;
&#xD;
        1. evaluate the feasibility of utilizing wearable devices to track health information&#xD;
           (i.e., sleep, physical activity);&#xD;
&#xD;
        2. evaluate the effectiveness of evidence-based intervention components on mood and&#xD;
           interpersonal functioning, family engagement, and sleep and physical activity level&#xD;
           outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Conner's Comprehensive Behavior Rating Scales</measure>
    <time_frame>12 months</time_frame>
    <description>Likert scale items measuring symptom presentation</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Mood Disorders in Children and Adolescents</condition>
  <arm_group>
    <arm_group_label>two-week family-based treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family-based treatment</intervention_name>
    <description>2-week family-based treatment</description>
    <arm_group_label>two-week family-based treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children and adolescents between the ages of 10 and 18 years;&#xD;
&#xD;
          -  Diagnosed with a primary depressive or bipolar disorder;&#xD;
&#xD;
          -  Admitted to the Child and Adolescent Integrated Mood Program (CAIMP) at Mayo Clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individual's not eligible for admission to the Child and Adolescent Integrated Mood&#xD;
             Program (CAIMP)at Mayo Clinic.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jarrod M Leffler</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>March 15, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Jarrod M. Leffler, Ph.D., L.P.</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>depression</keyword>
  <keyword>bipolar</keyword>
  <keyword>caregivers</keyword>
  <keyword>children</keyword>
  <keyword>adolescents</keyword>
  <keyword>treatment</keyword>
  <keyword>parents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mood Disorders</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/NCT03800303
org study id: 17-010831
nct id: NCT03800303
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In an effort to understand the effects of evidence-based interventions on children and
      adolescents, the aims of this study are to:

        1. evaluate the feasibility of utilizing wearable devices to track health information
           (i.e., sleep, physical activity);

        2. evaluate the effectiveness of evidence-based intervention components on mood and
           interpersonal functioning, family engagement, and sleep and physical activity level
           outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Conner's Comprehensive Behavior Rating Scales
time frame: 12 months
description: Likert scale items measuring symptom presentation
arm group label: two-week family-based treatment
arm group type: Experimental
description: Active treatment includes a two-week family-based partial hospitalization treatment utilizing and integrated therapeutic design.
intervention type: Behavioral
intervention name: Family-based treatment
description: 2-week family-based treatment
arm group label: two-week family-based treatment
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Jarrod M Leffler
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Jarrod M. Leffler, Ph.D., L.P.
investigator title: Assistant Professor
mesh term: Mood Disorders