<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/NCT01708226</url>
  </required_header>
  <id_info>
    <org_study_id>IRB12-001459</org_study_id>
    <secondary_id>1R34MH095885-01A1</secondary_id>
    <nct_id>NCT01708226</nct_id>
  </id_info>
  <brief_title>Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series</brief_title>
  <acronym>AMPOCD</acronym>
  <official_title>Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues&#xD;
      significant concurrent and long-term risk to affected youth. Although empirically supported&#xD;
      psychosocial and pharmacological treatments for OCD exist, many children and their families&#xD;
      are not able to adequately access these treatments or derive only partial benefit from them.&#xD;
      Such findings highlight the importance of developing more effective treatment options which&#xD;
      have the potential to be widely accessible to OCD youth.&#xD;
&#xD;
      The investigators are proposing to test a computerized attention modification program, AMP,&#xD;
      in six youth with OCD in an open case series to gather information regarding protocol&#xD;
      acceptability, feasibility and preliminary efficacy. This phase includes the development and&#xD;
      refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP&#xD;
      parameters for use with children.&#xD;
&#xD;
      Following ascertainment of study eligibility, participants will undergo a baseline assessment&#xD;
      consisting of a clinical interview, neurocognitive assessments, EEG, attention bias&#xD;
      assessment, and self report questionnaires. Study participants will then receive 12 sessions&#xD;
      of AMP treatment over the course of three weeks. All youngsters and their families will be&#xD;
      reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours&#xD;
      over the course of six weeks. Participants who are treatment responders may be asked to&#xD;
      return approximately 3 months after completing treatment for a follow-up assessment.&#xD;
&#xD;
      Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to&#xD;
      administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom&#xD;
      severity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment</measure>
    <time_frame>pre-treatment (week 0) and post-treatment (week 5)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment</measure>
    <time_frame>pre-treatment (week 0) and post-treatment (week 5)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attention Bias Assessment Change from Pre-Treatment to Post-Treatment</measure>
    <time_frame>pre-treatment (week 0) and post-treatment (week 5)</time_frame>
    <description>Computerized assessment of attention bias</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Obsessive Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Attention Modification Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Attention Modification Program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Modification Program</intervention_name>
    <description>Computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief.</description>
    <arm_group_label>Attention Modification Program</arm_group_label>
    <other_name>AMP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Youth ages 8 - 17&#xD;
&#xD;
          -  Primary DSM-IV diagnosis of OCD as determined by Anxiety Disorders Interview Schedule&#xD;
             (ADIS-IV) Child/Parent version&#xD;
&#xD;
          -  Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) score &gt; 15&#xD;
&#xD;
          -  Medication free or on stable medication for six weeks prior to study entry&#xD;
&#xD;
          -  Informed parental consent and child assent. Parents must agree to their child's&#xD;
             participation in this protocol. Parents will be asked to fill out self-report&#xD;
             questionnaires and participate in assessments that will provide us with more&#xD;
             information about their child, however parents are not considered &quot;participants&quot;&#xD;
             within this protocol, as all treatment is targeted toward their child.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DSM-IV depressive disorder, bipolar disorder, PTSD, substance abuse/dependence,&#xD;
             conduct disorder, PDD, schizophrenia, or mental retardation&#xD;
&#xD;
          -  Concurrent psychosocial treatment for OCD&#xD;
&#xD;
          -  IQ &lt; 80&#xD;
&#xD;
          -  Youngsters with other comorbid disorders (e.g., anxiety, ADHD, ODD, tic disorder) will&#xD;
             be eligible as long as these disorders are secondary to OCD in terms of severity and&#xD;
             impairment and do not require immediate treatment initiation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susanna Chang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Piacentini, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James McCraken, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Susanna Chang, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>OCD</keyword>
  <keyword>obsessive compulsive disorder</keyword>
  <keyword>children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01708226
org study id: IRB12-001459
secondary id: 1R34MH095885-01A1
nct id: NCT01708226
lead sponsor: 
collaborator: 
has dmc: Yes
Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues
      significant concurrent and long-term risk to affected youth. Although empirically supported
      psychosocial and pharmacological treatments for OCD exist, many children and their families
      are not able to adequately access these treatments or derive only partial benefit from them.
      Such findings highlight the importance of developing more effective treatment options which
      have the potential to be widely accessible to OCD youth.

      The investigators are proposing to test a computerized attention modification program, AMP,
      in six youth with OCD in an open case series to gather information regarding protocol
      acceptability, feasibility and preliminary efficacy. This phase includes the development and
      refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP
      parameters for use with children.

      Following ascertainment of study eligibility, participants will undergo a baseline assessment
      consisting of a clinical interview, neurocognitive assessments, EEG, attention bias
      assessment, and self report questionnaires. Study participants will then receive 12 sessions
      of AMP treatment over the course of three weeks. All youngsters and their families will be
      reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours
      over the course of six weeks. Participants who are treatment responders may be asked to
      return approximately 3 months after completing treatment for a follow-up assessment.

      Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to
      administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom
      severity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment
time frame: pre-treatment (week 0) and post-treatment (week 5)
measure: Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment
time frame: pre-treatment (week 0) and post-treatment (week 5)
measure: Attention Bias Assessment Change from Pre-Treatment to Post-Treatment
time frame: pre-treatment (week 0) and post-treatment (week 5)
description: Computerized assessment of attention bias
arm group label: Attention Modification Program
arm group type: Experimental
description: Attention Modification Program
intervention type: Behavioral
intervention name: Attention Modification Program
description: Computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief.
arm group label: Attention Modification Program
other name: AMP
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Susanna Chang, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: John Piacentini, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: James McCraken, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Susanna Chang, PhD
investigator title: Assistant Professor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
sharing ipd: No