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/NCT06020261</url>
    </required_header>
    <id_info>
      <org_study_id>23-0065</org_study_id>
      <nct_id>NCT06020261</nct_id>
    </id_info>
    <brief_title>Parent Management Training to Treat Irritability</brief_title>
    <acronym>PMT</acronym>
    <official_title>Parent Management Training to Treat Irritability</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Children's Hospital Colorado</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Colorado, Denver</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>
        This is a pilot study to determine if the investigator can accrue a diverse sample of 30&#xD;
        children with significant irritability, conduct manualized Parent Management Training (PMT)&#xD;
        with this group and measure physiology during pre- and post- PMT visits. The investigator&#xD;
        will also aim to demonstrate the initial efficacy of PMT for irritability and utilize this&#xD;
        trial to serve as a standard of care comparison for future studies.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Up to 45 participants will be consented for this Parent Management Training (PMT) to Treat&#xD;
        Irritability study in order to meet the aim of having 30 participants complete the study. The&#xD;
        child participant and a parent will complete a pre-treatment study visit to evaluate mental&#xD;
        health, behavior and cognitive functioning. Participants who meet inclusion criteria (age&#xD;
        10-14 with significant irritability) and do not meet exclusion criteria (e.g. Autism, Bipolar&#xD;
        disorder, active PTSD, serious medical issues or Intellectual disability) will be invited to&#xD;
        join the trial. All participants will receive an active treatment of 12 PMT sessions from a&#xD;
        licensed or license eligible clinician supervised by a licensed clinician. These session will&#xD;
        focus on the parents only, but both the parent and child will complete standardized measures&#xD;
        during treatment. After the 12 sessions of PMT, the parent and child will complete a&#xD;
        post-treatment visit to complete measures. Pre and post treatment measures will be compared&#xD;
        to determine improvement in irritability as well as other areas of functioning.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>
      <intervention_model_description>pre assessment, 12 sessions of manualized Parent Management Training, post assessment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>recruitment feasibility</measure>
      <time_frame>one year</time_frame>
      <description>The number of participants completing 12 sessions of PMT in one year will be at least 30.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>reduction in irritability</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will report a decrease in irritability as measured by the ARI.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Irritable Mood</condition>
    <condition>Temper Tantrum</condition>
    <condition>Anger</condition>
    <arm_group>
      <arm_group_label>Parent Management Training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>12 sessions of manualized Parent Management Training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Parent Management Training</intervention_name>
      <description>developing parenting skills and competencies dealing with oppositional and irritable behaviors in the child.</description>
      <arm_group_label>Parent Management Training</arm_group_label>
      <other_name>behavioral treatment</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  clinically significant irritability (Clinician Affective Reactivity Index 3 or&#xD;
               greater)&#xD;
  &#xD;
            -  parent or guardian willing to participate in treatment with the child&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  psychiatric instability (danger to self/others, risky substance abuse)&#xD;
  &#xD;
            -  current active PTSD or a severe active stressor (e.g. child maltreatment)&#xD;
  &#xD;
            -  history of severe psychopathology with an established alternate treatment (e.g. autism&#xD;
               spectrum disorder, bipolar disorder, schizophrenia, intellectual disability)&#xD;
  &#xD;
            -  general medical condition that may be driving irritability or prevent generalizable&#xD;
               physiologic measures.&#xD;
  &#xD;
            -  screen positive for an intellectual disability via WASI II estimated IQ&lt;70.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joel Stoddard, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Colorado Denver, Anschutz Medical Campus</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jami Moe-Hartman, MA</last_name>
      <phone>303-724-2259</phone>
      <email>jami.moehartman@cuanschutz.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jessica Hawks, PhD</last_name>
      <phone>720-777-8214</phone>
      <email>jessica.hawks@childrenscolorado.org</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Parent management</keyword>
    <keyword>irritability</keyword>
    <keyword>anger</keyword>
    <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/NCT06020261
  org study id: 23-0065
  nct id: NCT06020261
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a pilot study to determine if the investigator can accrue a diverse sample of 30
        children with significant irritability, conduct manualized Parent Management Training (PMT)
        with this group and measure physiology during pre- and post- PMT visits. The investigator
        will also aim to demonstrate the initial efficacy of PMT for irritability and utilize this
        trial to serve as a standard of care comparison for future studies.
  Up to 45 participants will be consented for this Parent Management Training (PMT) to Treat
        Irritability study in order to meet the aim of having 30 participants complete the study. The
        child participant and a parent will complete a pre-treatment study visit to evaluate mental
        health, behavior and cognitive functioning. Participants who meet inclusion criteria (age
        10-14 with significant irritability) and do not meet exclusion criteria (e.g. Autism, Bipolar
        disorder, active PTSD, serious medical issues or Intellectual disability) will be invited to
        join the trial. All participants will receive an active treatment of 12 PMT sessions from a
        licensed or license eligible clinician supervised by a licensed clinician. These session will
        focus on the parents only, but both the parent and child will complete standardized measures
        during treatment. After the 12 sessions of PMT, the parent and child will complete a
        post-treatment visit to complete measures. Pre and post treatment measures will be compared
        to determine improvement in irritability as well as other areas of functioning.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: pre assessment, 12 sessions of manualized Parent Management Training, post assessment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: recruitment feasibility
  time frame: one year
  description: The number of participants completing 12 sessions of PMT in one year will be at least 30.
  measure: reduction in irritability
  time frame: 12 weeks
  description: Participants will report a decrease in irritability as measured by the ARI.
  arm group label: Parent Management Training
  arm group type: Experimental
  description: 12 sessions of manualized Parent Management Training.
  intervention type: Behavioral
  intervention name: Parent Management Training
  description: developing parenting skills and competencies dealing with oppositional and irritable behaviors in the child.
  arm group label: Parent Management Training
  other name: behavioral treatment
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 14 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joel Stoddard, MD
  role: Principal Investigator
  affiliation: University of Colorado Denver, Anschutz Medical Campus
  last name: Jami Moe-Hartman, MA
  phone: 303-724-2259
  email: jami.moehartman@cuanschutz.edu
  last name: Jessica Hawks, PhD
  phone: 720-777-8214
  email: jessica.hawks@childrenscolorado.org
  responsible party type: Sponsor
  sharing ipd: No