<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/NCT02998073</url>
  </required_header>
  <id_info>
    <org_study_id>0702016</org_study_id>
    <nct_id>NCT02998073</nct_id>
  </id_info>
  <brief_title>Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder</brief_title>
  <official_title>A Multiple Biomarker Approach to Investigating Psychosocial Intervention Treatment Response in Justice-Involved Youth With Conduct Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ontario Mental Health Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Addiction and Mental Health</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 research focuses on youth with conduct disorder (CD), and a history of violence. CD is a&#xD;
      youth neurodevelopmental disorder that is commonly associated with criminality. Although&#xD;
      psychosocial interventions that address impulsivity and self-control have been shown to be&#xD;
      effective at helping promote prosocial behavior in patients with CD, the biological changes&#xD;
      that occur as a result of treatment are not well understood. This study will explore changes&#xD;
      in the brain function of the anterior cingulate cortex (ACC) in response to a common&#xD;
      psychosocial intervention (Stop, Now and Plan). This study will contribute to our&#xD;
      understanding of biological mechanisms involved in therapeutic gains among children with&#xD;
      behavioural problems and youth offenders; therefore, it will inform further development of&#xD;
      treatment programs for children/youth with impulsive behaviours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CD is a youth-limited neurodevelopmental disorder characterized by impulsivity and&#xD;
      dysfunctional social behavior. CD is associated with increased risks of mortality, lower&#xD;
      educational and occupational achievement, criminal behavior and other psychosocial&#xD;
      difficulties, and hence presents a significant burden to society. Impulsivity is a prominent&#xD;
      predictor of violence in CD. Treatment programs targeting impulsivity in CD have been shown&#xD;
      to be effective at increasing pro-social functioning in CD, but the biological mechanisms&#xD;
      that underpin these therapeutic gains are not well understood. Past research suggests that&#xD;
      the ACC play a role in CD and impulsivity. This study explores biological and behavioral&#xD;
      changes in response to Stop, Now and Plan (SNAP), a validated 13-week psychosocial&#xD;
      intervention addressing impulsivity and self-control in youth.&#xD;
&#xD;
      The main hypotheses are:&#xD;
&#xD;
      (1) CD youth who respond to SNAP treatment will exhibit greater post-treatment ACC activation&#xD;
      during an fMRI imaging task compared with their baseline, pre-treatment ACC activation.&#xD;
&#xD;
      The secondary hypotheses are:&#xD;
&#xD;
      (1) CD youth will exhibit lower ACC activation at baseline during an fMRI imaging task&#xD;
      compared with the baseline ACC activation exhibited by typically developing youth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">August 11, 2021</completion_date>
  <primary_completion_date type="Actual">February 5, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline: blood-oxygen-level dependent (BOLD) activation of anterior cingulate cortex as measured by functional magnetic resonance imaging</measure>
    <time_frame>Measured before and after the 13-week program</time_frame>
    <description>Difference in ACC BOLD activation to commission errors (contrast of BOLD response during commission errors vs. BOLD response during correct hits) will be tested using a 2 (Session: pre-SNAP vs. post-SNAP) × 2 (Group: treatment responders vs. non-treatment responders) within subject, mixed model analysis of covariance (ANCOVA), controlling for the effect of age, to investigate the two-way interaction between session and group. (Note: Commission errors compose a measure produced by the Go/No-Go task.)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Conduct Disorder</condition>
  <arm_group>
    <arm_group_label>Conduct Disorder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are justice-involved youth with conduct disorder. Participants will receive Stop, Now and Plan (SNAP) psychosocial intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants are healthy males. Participants receive no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stop, Now and Plan</intervention_name>
    <description>SNAP program was developed to target justice-involved youth (6 years and older) who have problems with aggression, CD, and/or gang affiliation. SNAP focuses on engaging youth in interesting and creative learning modules by providing real life scenarios designed to improve self-control, impulsive behaviors, decision-making skills, and pro-social skills. SNAP treatment is delivered over a 13-week period.</description>
    <arm_group_label>Conduct Disorder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (SNAP Treatment Group):&#xD;
&#xD;
        - Historical diagnosis of CD as per the K-SADS, which will be corroborated by DSM-5&#xD;
        criteria obtained by clinical assessment, and a CBCL, externalizing sub-score of 70 and&#xD;
        above.&#xD;
&#xD;
        Inclusion Criteria (SNAP Control Group)&#xD;
&#xD;
          -  No history of psychiatric illness as assessed by the Kiddi - Schedule for Affective&#xD;
             Disorders and Schizophrenia Present and Lifetime version (K-SADS)&#xD;
&#xD;
          -  No history of criminal justice system involvement.&#xD;
&#xD;
        Exclusion Criteria (ALL Groups):&#xD;
&#xD;
          -  Serious, unstable medical condition that precludes safe participation in the study&#xD;
&#xD;
          -  History of neurological or endocrine disorder&#xD;
&#xD;
          -  Any contraindication to safe MRI scanning, including claustrophobia&#xD;
&#xD;
          -  Psychotic or bipolar disorder&#xD;
&#xD;
          -  Current drug use measured by urinalysis&#xD;
&#xD;
          -  Full-scale IQ of 80 or lower (cut-off for borderline intellectual functioning)&#xD;
             measured using the Wechsler Abbreviated Scales of Intelligence - 2nd Edition (WASI-II)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Kolla, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T1R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.camh.net/research</url>
    <description>Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre</description>
  </link>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>August 12, 2021</last_update_submitted>
  <last_update_submitted_qc>August 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Nathan Kolla</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conduct 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/NCT02998073
org study id: 0702016
nct id: NCT02998073
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research focuses on youth with conduct disorder (CD), and a history of violence. CD is a
      youth neurodevelopmental disorder that is commonly associated with criminality. Although
      psychosocial interventions that address impulsivity and self-control have been shown to be
      effective at helping promote prosocial behavior in patients with CD, the biological changes
      that occur as a result of treatment are not well understood. This study will explore changes
      in the brain function of the anterior cingulate cortex (ACC) in response to a common
      psychosocial intervention (Stop, Now and Plan). This study will contribute to our
      understanding of biological mechanisms involved in therapeutic gains among children with
      behavioural problems and youth offenders; therefore, it will inform further development of
      treatment programs for children/youth with impulsive behaviours.
CD is a youth-limited neurodevelopmental disorder characterized by impulsivity and
      dysfunctional social behavior. CD is associated with increased risks of mortality, lower
      educational and occupational achievement, criminal behavior and other psychosocial
      difficulties, and hence presents a significant burden to society. Impulsivity is a prominent
      predictor of violence in CD. Treatment programs targeting impulsivity in CD have been shown
      to be effective at increasing pro-social functioning in CD, but the biological mechanisms
      that underpin these therapeutic gains are not well understood. Past research suggests that
      the ACC play a role in CD and impulsivity. This study explores biological and behavioral
      changes in response to Stop, Now and Plan (SNAP), a validated 13-week psychosocial
      intervention addressing impulsivity and self-control in youth.

      The main hypotheses are:

      (1) CD youth who respond to SNAP treatment will exhibit greater post-treatment ACC activation
      during an fMRI imaging task compared with their baseline, pre-treatment ACC activation.

      The secondary hypotheses are:

      (1) CD youth will exhibit lower ACC activation at baseline during an fMRI imaging task
      compared with the baseline ACC activation exhibited by typically developing youth.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline: blood-oxygen-level dependent (BOLD) activation of anterior cingulate cortex as measured by functional magnetic resonance imaging
time frame: Measured before and after the 13-week program
description: Difference in ACC BOLD activation to commission errors (contrast of BOLD response during commission errors vs. BOLD response during correct hits) will be tested using a 2 (Session: pre-SNAP vs. post-SNAP) × 2 (Group: treatment responders vs. non-treatment responders) within subject, mixed model analysis of covariance (ANCOVA), controlling for the effect of age, to investigate the two-way interaction between session and group. (Note: Commission errors compose a measure produced by the Go/No-Go task.)
arm group label: Conduct Disorder
arm group type: Experimental
description: Participants are justice-involved youth with conduct disorder. Participants will receive Stop, Now and Plan (SNAP) psychosocial intervention.
arm group label: Control
arm group type: No Intervention
description: Participants are healthy males. Participants receive no intervention.
intervention type: Behavioral
intervention name: Stop, Now and Plan
description: SNAP program was developed to target justice-involved youth (6 years and older) who have problems with aggression, CD, and/or gang affiliation. SNAP focuses on engaging youth in interesting and creative learning modules by providing real life scenarios designed to improve self-control, impulsive behaviors, decision-making skills, and pro-social skills. SNAP treatment is delivered over a 13-week period.
arm group label: Conduct Disorder
criteria: 
gender: Male
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nathan Kolla, MD, PhD
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
country: Canada
url: http://www.camh.net/research
description: Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Nathan Kolla
investigator title: Principal Investigator
mesh term: Conduct Disorder
sharing ipd: No