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/NCT05967468</url>
    </required_header>
    <id_info>
      <org_study_id>H-53969</org_study_id>
      <nct_id>NCT05967468</nct_id>
    </id_info>
    <brief_title>Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder</brief_title>
    <official_title>Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Baylor College of Medicine</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>
        Anxiety and obsessive-compulsive disorders are among the most common in children. Although&#xD;
        cognitive behavioral therapy (CBT) is an effective and evidence-based treatment for such&#xD;
        disorders, access to CBT is often limited. Family-based and internet-delivered therapy is one&#xD;
        method to increase access to care. The purpose of this project is to evaluate the comparative&#xD;
        efficacy and treatment mechanisms of two lower-intensity but effective treatments for&#xD;
        families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth&#xD;
        compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving&#xD;
        breathing exercises with a therapist.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cognitive-behavioral therapy (CBT) is an effective treatment for anxiety, yet access to CBT&#xD;
        is limited for most families due to the cost, practicalities of attending in-person treatment&#xD;
        sessions, and limited availability of trained therapists. Low-intensity telehealth delivery&#xD;
        of services is a promising method to improve access to care for youth with anxiety and their&#xD;
        families, givens its reachability to a wider range of areas (e.g., rural/underserved) and its&#xD;
        ability to minimize practical barriers (e.g., treatment could be delivered to home without&#xD;
        need for travel), and reduce stigma (e.g., parents do not need to visit mental health&#xD;
        clinics). Additionally, parent-involved treatments for youth anxiety are effective and have&#xD;
        the potential to reach more children and adolescents who refuse to see a therapist. However,&#xD;
        these interventions have not been widely evaluated. The goal of this project is to evaluate&#xD;
        the comparative efficacy and treatment mechanisms of two lower-intensity but effective&#xD;
        treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via&#xD;
        telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention&#xD;
        involving breathing exercises with a therapist. This study involves two CBT-based&#xD;
        intervention groups, both of which have demonstrated efficacy in prior work: 1) a parent-led,&#xD;
        therapist-supported Internet based CBT intervention (iCBT) and 2) parent training paired with&#xD;
        bibliotherapy intervention (SPACE).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 14, 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>
      <intervention_model_description>Children (N=100), ages 7-13 will be randomized to one of three conditions</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcomes assessor is blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in clinician-rated child anxiety severity throughout the past week.</measure>
      <time_frame>baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up</time_frame>
      <description>Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings</measure>
      <time_frame>baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up</time_frame>
      <description>Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical Global Impression-Severity</measure>
      <time_frame>baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up</time_frame>
      <description>Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Obsessive-Compulsive Disorder in Children</condition>
    <condition>Anxiety Disorder of Childhood</condition>
    <condition>Social Anxiety Disorder of Childhood</condition>
    <condition>Obsessive-Compulsive Disorder in Adolescence</condition>
    <condition>Generalized Anxiety Disorder</condition>
    <condition>Separation Anxiety</condition>
    <condition>Panic Disorder</condition>
    <condition>Panic Disorder With Agoraphobia</condition>
    <condition>Panic Attacks</condition>
    <arm_group>
      <arm_group_label>Family-Based Internet-Based CBT Group (iCBT)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One third of participants will be randomized to receive iCBT. Each week of treatment, the parent will be encouraged to read the corresponding materials on the Baylor College of Medicine (BCM) webpage, complete accompanying worksheets, and guide their child through completing activities in the child-facing materials, with support from a therapist (6 30-minute supportive videoconferencing via Zoom, 6 emails on alternating weeks). One core aspect of treatment will be parents leading their child through graduated exposure. Exposures, a hallmark of CBT for anxiety, are used to gradually and repeatedly confront feared stimuli. For example, exposure therapy for a child fearful of dogs may begin with looking at pictures of dogs and standing across the park from a dog on a leash, to eventually petting a dog. All relevant information regarding parent-led exposures will be detailed in the treatment materials, and therapists will review with parents via email and/or video-conferencing sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Parent Training Bibliotherapy (SPACE)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>One third of participants will be randomized to the SPACE group. Families will receive 4 45-minute supportive video calls with a therapist over the course of 12-14 weeks. Participating families will receive a copy of the book 'Breaking Free of Child Anxiety and OCD' to use at home and in session with the therapist. During each of the video-conferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active Comparator</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>One third of participants will be randomized to receive a Relaxation and Mentorship. This involves attending 4 45-minute sessions with a therapist over the course of 12-14 weeks. Topics covered include breathing slowly and deeply, coloring activities, and releasing muscle tension to reduce stress levels.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Family Based, Internet-Based Cognitive Behavioral Therapy</intervention_name>
      <description>Family-based cognitive behavioral therapy employing internet-delivered modules and videos</description>
      <arm_group_label>Family-Based Internet-Based CBT Group (iCBT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Bibliotherapy, low therapist contact SPACE</intervention_name>
      <description>Parent-based bibliotherapy for treating anxiety disorders in youth</description>
      <arm_group_label>Parent Training Bibliotherapy (SPACE)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Relaxation and Mentorship</intervention_name>
      <description>Relaxation based treatment</description>
      <arm_group_label>Active Comparator</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The child is between the ages of 7 to 13 years inclusion at enrollment&#xD;
  &#xD;
            -  The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a&#xD;
               score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).&#xD;
  &#xD;
            -  The child is appropriate for anxiety-focused treatment (e.g., anxiety is the primary&#xD;
               or co-primary problem as diagnosed using the Mini-International Neuropsychiatric&#xD;
               Interview for Children and Adolescents (MINI-KID).&#xD;
  &#xD;
            -  One parent/guardian is able and willing to participate in assessment and treatment&#xD;
               (e.g., has sufficient English fluency, the decisional capacity to participate, and can&#xD;
               commit to treatment duration).&#xD;
  &#xD;
            -  The participating parent/guardian lives with their child at least 50% of the time per&#xD;
               self-report.&#xD;
  &#xD;
            -  Both parent and child are able to read and understand English.&#xD;
  &#xD;
            -  The child has the intellectual and communication skills to engage in CBT, as judged by&#xD;
               an experienced supervising clinician.&#xD;
  &#xD;
            -  Participants must be in the state of Texas for treatment sessions/assessments.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  the child has a diagnosis of child lifetime bipolar disorder, drug or alcohol&#xD;
               dependence, psychotic disorder, or conduct disorder.&#xD;
  &#xD;
            -  the child has severe, current suicidal/homicidal ideation and/or self-injury requiring&#xD;
               medical intervention (referrals will be made for appropriate clinical intervention).&#xD;
  &#xD;
            -  the child is receiving concurrent therapy for anxiety.&#xD;
  &#xD;
            -  New Treatments: Initiation of an antidepressant within 12 weeks before study&#xD;
               enrollment OR 6 weeks for an antipsychotic, benzodiazepine, or attention deficit&#xD;
               hyperactivity disorder (ADHD) medication before study enrollment. Established&#xD;
               Treatment changes: Any change in established psychotropic medication (e.g.,&#xD;
               antidepressants, anxiolytics, antipsychotic) within 4 weeks before study enrollment.&#xD;
               Any medications must remain stable during treatment; downward adjustments due to side&#xD;
               effects may be acceptable.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>13 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Daphne Ayton, B.A.</last_name>
      <phone>832-206-4034</phone>
      <email>daphne.ayton@bcm.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eric Storch, Ph.D.</last_name>
      <phone>(713) 798-3579</phone>
      <email>eric.storch@bcm.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Baylor College of Medicine</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eric Storch, Ph.D.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 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>Baylor College of Medicine</investigator_affiliation>
      <investigator_full_name>Eric A Storch</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>obsessive-compulsive disorder</keyword>
    <keyword>anxiety</keyword>
    <keyword>cognitive-behavioral therapy</keyword>
    <keyword>children</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
      <mesh_term>Compulsive Personality Disorder</mesh_term>
      <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
      <mesh_term>Panic Disorder</mesh_term>
      <mesh_term>Phobia, Social</mesh_term>
      <mesh_term>Agoraphobia</mesh_term>
      <mesh_term>Anxiety, Separation</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/NCT05967468
  org study id: H-53969
  nct id: NCT05967468
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Anxiety and obsessive-compulsive disorders are among the most common in children. Although
        cognitive behavioral therapy (CBT) is an effective and evidence-based treatment for such
        disorders, access to CBT is often limited. Family-based and internet-delivered therapy is one
        method to increase access to care. The purpose of this project is to evaluate the comparative
        efficacy and treatment mechanisms of two lower-intensity but effective treatments for
        families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth
        compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving
        breathing exercises with a therapist.
  Cognitive-behavioral therapy (CBT) is an effective treatment for anxiety, yet access to CBT
        is limited for most families due to the cost, practicalities of attending in-person treatment
        sessions, and limited availability of trained therapists. Low-intensity telehealth delivery
        of services is a promising method to improve access to care for youth with anxiety and their
        families, givens its reachability to a wider range of areas (e.g., rural/underserved) and its
        ability to minimize practical barriers (e.g., treatment could be delivered to home without
        need for travel), and reduce stigma (e.g., parents do not need to visit mental health
        clinics). Additionally, parent-involved treatments for youth anxiety are effective and have
        the potential to reach more children and adolescents who refuse to see a therapist. However,
        these interventions have not been widely evaluated. The goal of this project is to evaluate
        the comparative efficacy and treatment mechanisms of two lower-intensity but effective
        treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via
        telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention
        involving breathing exercises with a therapist. This study involves two CBT-based
        intervention groups, both of which have demonstrated efficacy in prior work: 1) a parent-led,
        therapist-supported Internet based CBT intervention (iCBT) and 2) parent training paired with
        bibliotherapy intervention (SPACE).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Children (N=100), ages 7-13 will be randomized to one of three conditions
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Outcomes assessor is blinded
  measure: Change in clinician-rated child anxiety severity throughout the past week.
  time frame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
  description: Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.
  measure: Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings
  time frame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
  description: Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.
  measure: Clinical Global Impression-Severity
  time frame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
  description: Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
  arm group label: Family-Based Internet-Based CBT Group (iCBT)
  arm group type: Experimental
  description: One third of participants will be randomized to receive iCBT. Each week of treatment, the parent will be encouraged to read the corresponding materials on the Baylor College of Medicine (BCM) webpage, complete accompanying worksheets, and guide their child through completing activities in the child-facing materials, with support from a therapist (6 30-minute supportive videoconferencing via Zoom, 6 emails on alternating weeks). One core aspect of treatment will be parents leading their child through graduated exposure. Exposures, a hallmark of CBT for anxiety, are used to gradually and repeatedly confront feared stimuli. For example, exposure therapy for a child fearful of dogs may begin with looking at pictures of dogs and standing across the park from a dog on a leash, to eventually petting a dog. All relevant information regarding parent-led exposures will be detailed in the treatment materials, and therapists will review with parents via email and/or video-conferencing sessions.
  arm group label: Parent Training Bibliotherapy (SPACE)
  arm group type: Experimental
  description: One third of participants will be randomized to the SPACE group. Families will receive 4 45-minute supportive video calls with a therapist over the course of 12-14 weeks. Participating families will receive a copy of the book 'Breaking Free of Child Anxiety and OCD' to use at home and in session with the therapist. During each of the video-conferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.
  arm group label: Active Comparator
  arm group type: Active Comparator
  description: One third of participants will be randomized to receive a Relaxation and Mentorship. This involves attending 4 45-minute sessions with a therapist over the course of 12-14 weeks. Topics covered include breathing slowly and deeply, coloring activities, and releasing muscle tension to reduce stress levels.
  intervention type: Behavioral
  intervention name: Family Based, Internet-Based Cognitive Behavioral Therapy
  description: Family-based cognitive behavioral therapy employing internet-delivered modules and videos
  arm group label: Family-Based Internet-Based CBT Group (iCBT)
  intervention type: Behavioral
  intervention name: Bibliotherapy, low therapist contact SPACE
  description: Parent-based bibliotherapy for treating anxiety disorders in youth
  arm group label: Parent Training Bibliotherapy (SPACE)
  intervention type: Other
  intervention name: Relaxation and Mentorship
  description: Relaxation based treatment
  arm group label: Active Comparator
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 13 Years
  healthy volunteers: No
  last name: Daphne Ayton, B.A.
  phone: 832-206-4034
  email: daphne.ayton@bcm.edu
  last name: Eric Storch, Ph.D.
  phone: (713) 798-3579
  email: eric.storch@bcm.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Baylor College of Medicine
  investigator full name: Eric A Storch
  investigator title: Professor
  mesh term: Anxiety Disorders
  mesh term: Compulsive Personality Disorder
  mesh term: Obsessive-Compulsive Disorder
  mesh term: Panic Disorder
  mesh term: Phobia, Social
  mesh term: Agoraphobia
  mesh term: Anxiety, Separation
  sharing ipd: No