<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/NCT03838835</url>
  </required_header>
  <id_info>
    <org_study_id>18-01424</org_study_id>
    <nct_id>NCT03838835</nct_id>
  </id_info>
  <brief_title>Equine Facilitated CBT Group Therapy for Youth Anxiety</brief_title>
  <official_title>Equine Facilitated Cognitive Behavioral Therapy (CBT) Group Therapy for Youth Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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 evaluate a 10-week equine facilitated cognitive behavioral&#xD;
      therapy (CBT) group program for youth between ages of 6 to 17 with symptoms of anxiety. The&#xD;
      program will be delivered at GallopNYC, a stable that provides equine-facilitated group&#xD;
      therapy to youth with a range of mental health problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The equine-facilitated group therapy normally provided at GallopNYC (Treatment as Usual, TAU)&#xD;
      will be compared to an augmented group program that will include CBT strategies, including&#xD;
      psychoeducation to the child and caregiver about anxiety, coping strategies to use when&#xD;
      anxious, and identifying and addressing dysfunctional thoughts that maintain anxiety.&#xD;
      Seventy-five children between 6 to 17 years of age will be randomized to TAU&#xD;
      (equine-facilitated group therapy), the augmented group therapy that contains CBT strategies,&#xD;
      or wait list control. Outcomes include anxiety symptoms, self-efficacy,receipt of services,&#xD;
      functioning and the child's relationship with the horse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Actual">May 26, 2020</completion_date>
  <primary_completion_date type="Actual">May 26, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety, as measured by the SCARED</measure>
    <time_frame>Baseline to 10 Weeks</time_frame>
    <description>41 item questionnaire scored on a 3-point Likert Scale ranging from &quot;not true&quot; to &quot;very true.&quot; Items are summed, with higher scores indicating more anxiety symptoms (a cutoff of 25 indicates an anxiety disorder).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Equine-facilitated group therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Augmented equine-facilitated CBT group program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control (WLC)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Augmented equine-facilitated CBT group program</intervention_name>
    <description>Consists of CBT strategies including 1) providing psychoeducation about anxiety, 2) teaching coping strategies when anxious,and 3) identifying and addressing dysfunctional thoughts that maintain anxiety.</description>
    <arm_group_label>Augmented equine-facilitated CBT group program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TAU is equine-facilitated group therapy</intervention_name>
    <description>TAU is equine-facilitated group therapy at GallopNYC, which consists of horseback riding and integrates strategies to support the development of cognitive, physical, emotional, and social skills.</description>
    <arm_group_label>Equine-facilitated group therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WLC</intervention_name>
    <description>WLC consists of youth who are not yet receiving any services at Gallop NYC.</description>
    <arm_group_label>Wait List Control (WLC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A child aged 6-17 seeking services for anxiety at Gallop NYC, who (based on the&#xD;
             screener administered by GallopNYC) evidence symptoms of anxiety (as measured by a&#xD;
             score of 2 or more on the GAD 2 item questionnaire) and a minimum functioning score of&#xD;
             51 (as measured by the child global assessment scale)&#xD;
&#xD;
          -  Caregivers will also serve as study respondents. To do so, they must meet the&#xD;
             following criteria:&#xD;
&#xD;
          -  Primary caregiver/ legal guardian of a child who meets eligibility criteria&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Providers will serve as study therapists. To do so, they must meet the following criteria:&#xD;
&#xD;
          -  PATH-certified provider employed at Gallop NYC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Child does not meet criteria for anxiety symptoms (as measured by a score of 2 or more&#xD;
             on the GAD 2 item questionnaire) and/or does not meet minimum level of functioning&#xD;
             (does not meet a minimum functioning score of 51 as measured by the child global&#xD;
             assessment scale)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly Hoagwood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Langone Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety 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/NCT03838835
org study id: 18-01424
nct id: NCT03838835
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate a 10-week equine facilitated cognitive behavioral
      therapy (CBT) group program for youth between ages of 6 to 17 with symptoms of anxiety. The
      program will be delivered at GallopNYC, a stable that provides equine-facilitated group
      therapy to youth with a range of mental health problems.
The equine-facilitated group therapy normally provided at GallopNYC (Treatment as Usual, TAU)
      will be compared to an augmented group program that will include CBT strategies, including
      psychoeducation to the child and caregiver about anxiety, coping strategies to use when
      anxious, and identifying and addressing dysfunctional thoughts that maintain anxiety.
      Seventy-five children between 6 to 17 years of age will be randomized to TAU
      (equine-facilitated group therapy), the augmented group therapy that contains CBT strategies,
      or wait list control. Outcomes include anxiety symptoms, self-efficacy,receipt of services,
      functioning and the child's relationship with the horse.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anxiety, as measured by the SCARED
time frame: Baseline to 10 Weeks
description: 41 item questionnaire scored on a 3-point Likert Scale ranging from "not true" to "very true." Items are summed, with higher scores indicating more anxiety symptoms (a cutoff of 25 indicates an anxiety disorder).
arm group label: Equine-facilitated group therapy
arm group type: Experimental
arm group label: Augmented equine-facilitated CBT group program
arm group type: Experimental
arm group label: Wait List Control (WLC)
arm group type: Other
intervention type: Behavioral
intervention name: Augmented equine-facilitated CBT group program
description: Consists of CBT strategies including 1) providing psychoeducation about anxiety, 2) teaching coping strategies when anxious,and 3) identifying and addressing dysfunctional thoughts that maintain anxiety.
arm group label: Augmented equine-facilitated CBT group program
intervention type: Behavioral
intervention name: TAU is equine-facilitated group therapy
description: TAU is equine-facilitated group therapy at GallopNYC, which consists of horseback riding and integrates strategies to support the development of cognitive, physical, emotional, and social skills.
arm group label: Equine-facilitated group therapy
intervention type: Other
intervention name: WLC
description: WLC consists of youth who are not yet receiving any services at Gallop NYC.
arm group label: Wait List Control (WLC)
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Kimberly Hoagwood, MD
role: Principal Investigator
affiliation: New York Langone Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders