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/NCT06025539</url>
    </required_header>
    <id_info>
      <org_study_id>Resilience training</org_study_id>
      <nct_id>NCT06025539</nct_id>
    </id_info>
    <brief_title>Animal-assisted Resilience Training for Children With Stressful Life Events or Autism Spectrum Disorder</brief_title>
    <acronym>AART</acronym>
    <official_title>Effects of an Animal-assisted Resilience Training for Children With a History of Stressful Life Events or a Diagnosis of Autism Spectrum Disorder: A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Basel, Switzerland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Basel, Switzerland</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 goal of this clinical trial is to learn about the effects of an animal-assisted&#xD;
        resilience training in children who experienced stressful life events or who have a diagnosis&#xD;
        of autism spectrum disorder. The main question it aims to answer is:&#xD;
  &#xD;
        • Is an animal-assisted resilience training a feasible approach to increase resilience in&#xD;
        children with a history of stressful life events or a diagnosis of autism spectrum disorder?&#xD;
  &#xD;
        Participants will take part in 12 training sessions of a standardized resilience training.&#xD;
        The training is group-based, takes place outdoors, and includes interactions with different&#xD;
        animals. It focuses on self-esteem, self-perception, dealing with emotions, and social&#xD;
        competence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2021</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Questionnaire on resources in childhood and adolescence</measure>
      <time_frame>18 weeks</time_frame>
      <description>Pre-to-post assessment changes in resilience</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Questionnaire to assess emotion regulation in children and adolescents</measure>
      <time_frame>18 weeks</time_frame>
      <description>Pre-to-post assessment changes in emotion regulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of attendend sessions</measure>
      <time_frame>12 weeks</time_frame>
      <description>Number of attended sessions over the course of the training</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feeling secure and motivation to participate as measured on a 0-10 scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>Motivation and feeling secure as measured at the beginning and end of each session</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention satisfaction as assessed in semi-structured interview</measure>
      <time_frame>18 weeks (follow-up)</time_frame>
      <description>Satisfaction with program content and structure, as measured by qualitative interview</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Strengths and Difficulties Questionnaire (SDQ)</measure>
      <time_frame>18 weeks</time_frame>
      <description>Pre-to-post assessment changes in peer-relationship problems and prosocial behavior measures</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <condition>Life Change Events</condition>
    <arm_group>
      <arm_group_label>Animal-assisted resilience training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12 sessions of group-based, animal-assisted resilience training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Animal-assisted resilience training</intervention_name>
      <description>Participants take part in 12 sessions (120 minutes each), each session focuses on a topic that is related to resilience. The intervention takes part outdoors on a farm, and includes interactions with several different animals. The training takes place in small groups, and includes exercises, observations, and discussions.</description>
      <arm_group_label>Animal-assisted resilience training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 2 and 4 years (toddler group) or 8 and 12 years (children group)&#xD;
  &#xD;
            -  History of at least one stressful life event experience OR diagnosis of autism&#xD;
               spectrum disorder&#xD;
  &#xD;
            -  Basic knowledge of either German or English of parents and child to follow the&#xD;
               instructions during the training sessions and completion of interviews.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Medical contraindications for contact with animals, such as allergies or phobia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Karin Hediger, Prof. Dr.</last_name>
      <phone>‭+41 79 519 78 85‬</phone>
      <email>karin.hediger@unibas.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Helen Koechlin, PD PhD</last_name>
      <email>helen.koechlin@uzh.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Basel</name>
        <address>
          <city>Basel</city>
          <zip>4055</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Karin Hediger, Prof. Dr.</last_name>
        <phone>‭+41 79 519 78 85‬</phone>
        <email>karin.hediger@unibas.ch</email>
      </contact>
      <contact_backup>
        <last_name>Helen Koechlin, PD PhD</last_name>
        <email>helen.koechlin@uzh.ch</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
      <mesh_term>Child Development Disorders, Pervasive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will be shared upon request and only once study results have been published.</ipd_description>
    </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/NCT06025539
  org study id: Resilience training
  nct id: NCT06025539
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the effects of an animal-assisted
        resilience training in children who experienced stressful life events or who have a diagnosis
        of autism spectrum disorder. The main question it aims to answer is:
  
        • Is an animal-assisted resilience training a feasible approach to increase resilience in
        children with a history of stressful life events or a diagnosis of autism spectrum disorder?
  
        Participants will take part in 12 training sessions of a standardized resilience training.
        The training is group-based, takes place outdoors, and includes interactions with different
        animals. It focuses on self-esteem, self-perception, dealing with emotions, and social
        competence.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Questionnaire on resources in childhood and adolescence
  time frame: 18 weeks
  description: Pre-to-post assessment changes in resilience
  measure: Questionnaire to assess emotion regulation in children and adolescents
  time frame: 18 weeks
  description: Pre-to-post assessment changes in emotion regulation
  measure: Number of attendend sessions
  time frame: 12 weeks
  description: Number of attended sessions over the course of the training
  measure: Feeling secure and motivation to participate as measured on a 0-10 scale
  time frame: 12 weeks
  description: Motivation and feeling secure as measured at the beginning and end of each session
  measure: Intervention satisfaction as assessed in semi-structured interview
  time frame: 18 weeks (follow-up)
  description: Satisfaction with program content and structure, as measured by qualitative interview
  measure: Strengths and Difficulties Questionnaire (SDQ)
  time frame: 18 weeks
  description: Pre-to-post assessment changes in peer-relationship problems and prosocial behavior measures
  arm group label: Animal-assisted resilience training
  arm group type: Experimental
  description: 12 sessions of group-based, animal-assisted resilience training.
  intervention type: Behavioral
  intervention name: Animal-assisted resilience training
  description: Participants take part in 12 sessions (120 minutes each), each session focuses on a topic that is related to resilience. The intervention takes part outdoors on a farm, and includes interactions with several different animals. The training takes place in small groups, and includes exercises, observations, and discussions.
  arm group label: Animal-assisted resilience training
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Karin Hediger, Prof. Dr.
  phone: ‭+41 79 519 78 85‬
  email: karin.hediger@unibas.ch
  last name: Helen Koechlin, PD PhD
  email: helen.koechlin@uzh.ch
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Switzerland
  responsible party type: Sponsor
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  sharing ipd: No
  ipd description: Data will be shared upon request and only once study results have been published.