<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/NCT01687764</url>
  </required_header>
  <id_info>
    <org_study_id>HCPA11-0249</org_study_id>
    <nct_id>NCT01687764</nct_id>
  </id_info>
  <brief_title>Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children</brief_title>
  <official_title>Combination of Active or Placebo Attentional Bias Modification Treatment (ABMT) to Either Cognitive Behavioral Group Therapy (CBGT) or Psychoeducational Control Intervention (PCI) for Anxiety Disorders in Children: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <brief_summary>
    <textblock>
      The objective of this project is to test the combination of active or placebo Attentional&#xD;
      Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or&#xD;
      Psychoeducational Control Intervention (PCI) for anxiety disorders in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pediatric Anxiety Rating Scale (PARS) / continuous</measure>
    <time_frame>Endpoint (week 10) and 6-month follow-up</time_frame>
    <description>Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous</measure>
    <time_frame>Endpoint (week-10) and 6-month follow-up</time_frame>
    <description>Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Screen for Children and Anxiety Related Emotional Disorders (SCARED)</measure>
    <time_frame>Endpoint (week-10) and 6-months follow-up</time_frame>
    <description>Score change in SCARED child and parent versions from baseline to week 10 and 6-months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Childhood Depression Inventory (CDI)</measure>
    <time_frame>Endpoint (week-10) and 6-month follow-up</time_frame>
    <description>Score change in CDI from baseline to week-10 and to 6-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)</measure>
    <time_frame>Endpoint (week-10) and 6-month follow-up</time_frame>
    <description>Score change in SNAP-IV from baseline to week-10 and 6-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spence Children's Anxiety Scale (SCAS)</measure>
    <time_frame>Endpoint (week-10) and 6-month follow-up</time_frame>
    <description>Score change in SCAS from baseline to week-10 and to 6-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological measures</measure>
    <time_frame>Endpoint (week-10) and 6-month follow-up</time_frame>
    <description>Change in neuropsychological measures from baseline to week-10 and 6-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological measures</measure>
    <time_frame>Endpoint (week-10) and 6-month follow-up</time_frame>
    <description>Change in biological measures from baseline to week-10 and to 6-month follow-up</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Generalized Anxiety Disorder</condition>
  <condition>Separation Anxiety Disorder</condition>
  <condition>Social Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>CBGT+ABMT(active)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>CBGT+ABMT(placebo)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PCI+ABMT(active)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PCI+ABMT(placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Attentional Bias Modification Treatment (ABMT) - Active</intervention_name>
    <description>The ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (&lt; or &gt;) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor.</description>
    <arm_group_label>CBGT+ABMT(active)</arm_group_label>
    <arm_group_label>PCI+ABMT(active)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Attentional Bias Modification Treatment - Placebo</intervention_name>
    <description>The Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation.</description>
    <arm_group_label>CBGT+ABMT(placebo)</arm_group_label>
    <arm_group_label>PCI+ABMT(placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Group Therapy</intervention_name>
    <description>&quot;FRIENDS for Life&quot; Australian protocol for the treatment of anxiety disorders in children</description>
    <arm_group_label>CBGT+ABMT(active)</arm_group_label>
    <arm_group_label>CBGT+ABMT(placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducational Control Intervention</intervention_name>
    <description>Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities</description>
    <arm_group_label>PCI+ABMT(active)</arm_group_label>
    <arm_group_label>PCI+ABMT(placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder&#xD;
             (SeAD) or Social Anxiety Disorder (SoAD) according to KSADS-PL psychiatric interview&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other psychiatric disorder that causes more impairment and suffering than GAD, SeAD or&#xD;
             SoAD in the clinical evaluation&#xD;
&#xD;
          -  Current or previous treatment (behavioral or pharmacological) for a psychaitric&#xD;
             disorder in childhood&#xD;
&#xD;
          -  IQ &lt; 70 (Raven)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gisele G Manfro, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Silvia H Koller, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Rio Grande do Sul / University of Psychology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gisele G Manfro, MD, PhD</last_name>
    <phone>+55 51 3359 8983</phone>
    <email>gmanfro@portoweb.com.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Giovanni A Salum Junior, MD</last_name>
    <phone>+55 51 3359 8983</phone>
    <email>gsalumjr@gmail.com.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Institute of Mental Health (NIMH)</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Queensland</name>
      <address>
        <city>Brisbane St Lucia</city>
        <state>Queensland</state>
        <zip>4072</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giovanni A Salum Junior, MD</last_name>
      <phone>+55 51 33598983</phone>
      <email>gsalumjr@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Rafaela Behs, MSc</last_name>
      <phone>+55 51 33598983</phone>
      <email>rafaelabehs@hotmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Gisele G Manfro, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Silvia H Koller, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giovanni A Salum Junior, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Circe S Petersen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rudineia Toazza</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rafaela B Jarros, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Diogo Souza</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tel-Aviv University</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>69987</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>October 26, 2011</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 14, 2012</last_update_submitted>
  <last_update_submitted_qc>September 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Generalized Anxiety Disorder (GAD)</keyword>
  <keyword>Separation Anxiety Disorder (SeAD)</keyword>
  <keyword>Social Anxiety Disorder (SoAD)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Phobia, Social</mesh_term>
    <mesh_term>Anxiety, Separation</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/NCT01687764
org study id: HCPA11-0249
nct id: NCT01687764
lead sponsor: 
The objective of this project is to test the combination of active or placebo Attentional
      Bias Modification Treatment (ABMT) to either Cognitive Behavioral Group Therapy (CBGT) or
      Psychoeducational Control Intervention (PCI) for anxiety disorders in children.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pediatric Anxiety Rating Scale (PARS) / continuous
time frame: Endpoint (week 10) and 6-month follow-up
description: Score change on Pediatric Anxiety Rating Scale (PARS) from baseline to week 10 and to 6-month follow-up
measure: Clinical Global Impression - Improvement Scale (CGI-I) / dichotomous
time frame: Endpoint (week-10) and 6-month follow-up
description: Percentage of subjects with less than 2 points in the CGI-I scale in week 10 and in 6-month follow-up
measure: Screen for Children and Anxiety Related Emotional Disorders (SCARED)
time frame: Endpoint (week-10) and 6-months follow-up
description: Score change in SCARED child and parent versions from baseline to week 10 and 6-months follow-up
measure: Childhood Depression Inventory (CDI)
time frame: Endpoint (week-10) and 6-month follow-up
description: Score change in CDI from baseline to week-10 and to 6-month follow-up
measure: Swanson, Nolan, and Pelham scale - Version IV (SNAP-IV)
time frame: Endpoint (week-10) and 6-month follow-up
description: Score change in SNAP-IV from baseline to week-10 and 6-month follow-up
measure: Spence Children's Anxiety Scale (SCAS)
time frame: Endpoint (week-10) and 6-month follow-up
description: Score change in SCAS from baseline to week-10 and to 6-month follow-up
measure: Neuropsychological measures
time frame: Endpoint (week-10) and 6-month follow-up
description: Change in neuropsychological measures from baseline to week-10 and 6-month follow-up
measure: Biological measures
time frame: Endpoint (week-10) and 6-month follow-up
description: Change in biological measures from baseline to week-10 and to 6-month follow-up
arm group label: CBGT+ABMT(active)
arm group type: Experimental
arm group label: CBGT+ABMT(placebo)
arm group type: Experimental
arm group label: PCI+ABMT(active)
arm group type: Experimental
arm group label: PCI+ABMT(placebo)
arm group type: Placebo Comparator
intervention type: Other
intervention name: Attentional Bias Modification Treatment (ABMT) - Active
description: The ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (< or >) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor.
arm group label: CBGT+ABMT(active)
arm group label: PCI+ABMT(active)
intervention type: Other
intervention name: Attentional Bias Modification Treatment - Placebo
description: The Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation.
arm group label: CBGT+ABMT(placebo)
arm group label: PCI+ABMT(placebo)
intervention type: Behavioral
intervention name: Cognitive Behavioral Group Therapy
description: "FRIENDS for Life" Australian protocol for the treatment of anxiety disorders in children
arm group label: CBGT+ABMT(active)
arm group label: CBGT+ABMT(placebo)
intervention type: Behavioral
intervention name: Psychoeducational Control Intervention
description: Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities
arm group label: PCI+ABMT(active)
arm group label: PCI+ABMT(placebo)
criteria: 
gender: All
minimum age: 7 Years
maximum age: 11 Years
healthy volunteers: No
last name: Gisele G Manfro, MD, PhD
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre
last name: Silvia H Koller, PhD
role: Principal Investigator
affiliation: Federal University of Rio Grande do Sul / University of Psychology
last name: Gisele G Manfro, MD, PhD
phone: +55 51 3359 8983
email: gmanfro@portoweb.com.br
last name: Giovanni A Salum Junior, MD
phone: +55 51 3359 8983
email: gsalumjr@gmail.com.br
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
country: Australia
country: Brazil
country: Israel
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Phobia, Social
mesh term: Anxiety, Separation