<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/NCT01710969</url>
  </required_header>
  <id_info>
    <org_study_id>DESPR DA023156</org_study_id>
    <secondary_id>R01DA023156</secondary_id>
    <nct_id>NCT01710969</nct_id>
  </id_info>
  <brief_title>Individual and Group Intervention Formats With Aggressive Children</brief_title>
  <official_title>Individual and Group Intervention Formats With Aggressive Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute on Drug Abuse (NIDA)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The planned study will randomly assign aggressive children to one of two versions of the&#xD;
      Coping Power child component. The two versions of Coping Power will either deliver the child&#xD;
      component of the program in the usual small group format (Group Coping Power: GCP) or in a&#xD;
      newly-developed individual format (Individual Coping Power: ICP). By providing a direct&#xD;
      comparison of two different formats of the same intervention, the planned study's design will&#xD;
      fill a critical gap in our current understanding of the relative effectiveness of group vs.&#xD;
      individual programs. Further, this study will allow for examination of the specific factors&#xD;
      that influence relative effectiveness of these two formats, important information with broad&#xD;
      implications for program development, training of clinicians, and intervention&#xD;
      implementation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim 1: The study will test the hypothesis that the Coping Power intervention will&#xD;
      produce larger effect sizes when delivered in an individual format in comparison to a group&#xD;
      format. Although there are advantages of both formats, pilot data suggests that the group&#xD;
      format may be diminishing the strength of outcome effects of intervention in comparison to&#xD;
      the same intervention delivered in individual format. This pilot data is consistent with some&#xD;
      prior findings, but a direct randomized comparison of children assigned to group versus&#xD;
      individual formats has not been conducted, despite the critically important conceptual,&#xD;
      clinical, and policy implications.&#xD;
&#xD;
      Hypothesis 1-1: It is hypothesized that ICP will produce greater reductions in behavior&#xD;
      outcomes including substance use, externalizing behavior problems, and delinquency at a&#xD;
      1-year follow-up, in comparison to GCP.&#xD;
&#xD;
      Hypothesis 1-2: it is hypothesized that the ICP condition will produce greater improvements&#xD;
      in children's social competence, which is directly targeted by the intervention, in&#xD;
      comparison to GCP.&#xD;
&#xD;
      Specific Aim 2: Individual and group variation in effect sizes will be an outcome of youth&#xD;
      behavior in the group (i.e., deviancy training) and group leader behavior management skill.&#xD;
      We see youth behavior to be highly influenced by group leader management practices. We&#xD;
      understand that some groups and/or individual children present challenges to even the most&#xD;
      competent group leaders, and therefore, variation will be observable and meaningful. The&#xD;
      design of the study allows for the testing of both group level and individual effects, and&#xD;
      linkage of these effects to specific behaviors. Such information will provide an empirical&#xD;
      basis for clinical training for group interventions with youth in general and Coping Power in&#xD;
      particular.&#xD;
&#xD;
      Hypothesis 2-1: It is hypothesized that peer escalation in the GCP condition will predict&#xD;
      worse outcomes, and that the level of group deviance in the GCP condition will moderate the&#xD;
      effectiveness of the GCP condition, with better outcome effects for the groups with the&#xD;
      highest initial screening scores.&#xD;
&#xD;
      Hypothesis 2-2: It is hypothesized that group interventions will be compromised by individual&#xD;
      children's reactions to the interpersonal dynamics of the groups, such as inadvertent&#xD;
      attention to deviant behavior and talk provided by group members and/or the group leader.&#xD;
&#xD;
      Hypothesis 2-3: It is hypothesized that level of positive group leader behaviors (directing&#xD;
      attention to rules, correcting behavior, providing praise for compliance, introduction and&#xD;
      review of activities, clear directions) will moderate the effectiveness of the GCP condition.&#xD;
&#xD;
      Specific Aim 3: Variability in outcome scores will differ between conditions. Hypothesis 3-1:&#xD;
      It is hypothesized that there will be greater variability in the outcome scores of children&#xD;
      in the GCP condition than in those of children in the ICP condition.&#xD;
&#xD;
      Specific Aim 4: Child characteristics will be examined as potential moderators of&#xD;
      intervention effects.&#xD;
&#xD;
      Hypothesis 4-1: It is hypothesized that youth with low effortful control will be most&#xD;
      vulnerable to deviancy effects in group interventions and therefore will show lower effect&#xD;
      sizes than youth higher in effortful control at baseline. Thus we expect effortful control to&#xD;
      function as a moderator of group intervention effectiveness, but not individual intervention&#xD;
      effectiveness.&#xD;
&#xD;
      Research Question 1: In addition, we will investigate the possibility that characteristics of&#xD;
      the youth's decision-making (impulsive decision-making; outcome expectations), affective&#xD;
      arousal (callous-unemotional traits; low physiological arousal in response to negative&#xD;
      consequences), temperament and behavior characteristics (baseline severity of aggressive&#xD;
      behavior); perceived and actual peer reactions (perceived peer competence; peer rejection;&#xD;
      peer victimization; deviant peers) and demographic characteristics (sex; age; race) will&#xD;
      moderate the effectiveness of both interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavior Assessment System for Children, Externalizing Behavior</measure>
    <time_frame>Baseline, Mid-Intervention, Post-Intervention; 1 year follow-up</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Aggressive Behavior</condition>
  <arm_group>
    <arm_group_label>Individual Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>behavioral - children receive the Coping Power program in an individual, face-to-face format</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>behavioral - children receive the Coping Power program in a small group format (5-6 children per group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual intervention</intervention_name>
    <description>34 weekly sessions of cognitive-behavioral Coping Power intervention, delivered in an individual one-to-one format</description>
    <arm_group_label>Individual Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Intervention</intervention_name>
    <description>34 weekly sessions of Coping Power intervention, delivered in a small group format (6 children per gorup)</description>
    <arm_group_label>Group Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  top 25% in teacher-rated aggression and above low-aggressive range in parent-rated&#xD;
             aggression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute on Drug Abuse (NIDA)</investigator_affiliation>
    <investigator_title>Professor and Doddridge Saxon Chairholder in Clinical Psychology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aggression</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/NCT01710969
org study id: DESPR DA023156
secondary id: R01DA023156
nct id: NCT01710969
lead sponsor: 
has dmc: Yes
The planned study will randomly assign aggressive children to one of two versions of the
      Coping Power child component. The two versions of Coping Power will either deliver the child
      component of the program in the usual small group format (Group Coping Power: GCP) or in a
      newly-developed individual format (Individual Coping Power: ICP). By providing a direct
      comparison of two different formats of the same intervention, the planned study's design will
      fill a critical gap in our current understanding of the relative effectiveness of group vs.
      individual programs. Further, this study will allow for examination of the specific factors
      that influence relative effectiveness of these two formats, important information with broad
      implications for program development, training of clinicians, and intervention
      implementation.
Specific Aim 1: The study will test the hypothesis that the Coping Power intervention will
      produce larger effect sizes when delivered in an individual format in comparison to a group
      format. Although there are advantages of both formats, pilot data suggests that the group
      format may be diminishing the strength of outcome effects of intervention in comparison to
      the same intervention delivered in individual format. This pilot data is consistent with some
      prior findings, but a direct randomized comparison of children assigned to group versus
      individual formats has not been conducted, despite the critically important conceptual,
      clinical, and policy implications.

      Hypothesis 1-1: It is hypothesized that ICP will produce greater reductions in behavior
      outcomes including substance use, externalizing behavior problems, and delinquency at a
      1-year follow-up, in comparison to GCP.

      Hypothesis 1-2: it is hypothesized that the ICP condition will produce greater improvements
      in children's social competence, which is directly targeted by the intervention, in
      comparison to GCP.

      Specific Aim 2: Individual and group variation in effect sizes will be an outcome of youth
      behavior in the group (i.e., deviancy training) and group leader behavior management skill.
      We see youth behavior to be highly influenced by group leader management practices. We
      understand that some groups and/or individual children present challenges to even the most
      competent group leaders, and therefore, variation will be observable and meaningful. The
      design of the study allows for the testing of both group level and individual effects, and
      linkage of these effects to specific behaviors. Such information will provide an empirical
      basis for clinical training for group interventions with youth in general and Coping Power in
      particular.

      Hypothesis 2-1: It is hypothesized that peer escalation in the GCP condition will predict
      worse outcomes, and that the level of group deviance in the GCP condition will moderate the
      effectiveness of the GCP condition, with better outcome effects for the groups with the
      highest initial screening scores.

      Hypothesis 2-2: It is hypothesized that group interventions will be compromised by individual
      children's reactions to the interpersonal dynamics of the groups, such as inadvertent
      attention to deviant behavior and talk provided by group members and/or the group leader.

      Hypothesis 2-3: It is hypothesized that level of positive group leader behaviors (directing
      attention to rules, correcting behavior, providing praise for compliance, introduction and
      review of activities, clear directions) will moderate the effectiveness of the GCP condition.

      Specific Aim 3: Variability in outcome scores will differ between conditions. Hypothesis 3-1:
      It is hypothesized that there will be greater variability in the outcome scores of children
      in the GCP condition than in those of children in the ICP condition.

      Specific Aim 4: Child characteristics will be examined as potential moderators of
      intervention effects.

      Hypothesis 4-1: It is hypothesized that youth with low effortful control will be most
      vulnerable to deviancy effects in group interventions and therefore will show lower effect
      sizes than youth higher in effortful control at baseline. Thus we expect effortful control to
      function as a moderator of group intervention effectiveness, but not individual intervention
      effectiveness.

      Research Question 1: In addition, we will investigate the possibility that characteristics of
      the youth's decision-making (impulsive decision-making; outcome expectations), affective
      arousal (callous-unemotional traits; low physiological arousal in response to negative
      consequences), temperament and behavior characteristics (baseline severity of aggressive
      behavior); perceived and actual peer reactions (perceived peer competence; peer rejection;
      peer victimization; deviant peers) and demographic characteristics (sex; age; race) will
      moderate the effectiveness of both interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Behavior Assessment System for Children, Externalizing Behavior
time frame: Baseline, Mid-Intervention, Post-Intervention; 1 year follow-up
arm group label: Individual Intervention
arm group type: Experimental
description: behavioral - children receive the Coping Power program in an individual, face-to-face format
arm group label: Group Intervention
arm group type: Experimental
description: behavioral - children receive the Coping Power program in a small group format (5-6 children per group)
intervention type: Behavioral
intervention name: Individual intervention
description: 34 weekly sessions of cognitive-behavioral Coping Power intervention, delivered in an individual one-to-one format
arm group label: Individual Intervention
intervention type: Behavioral
intervention name: Group Intervention
description: 34 weekly sessions of Coping Power intervention, delivered in a small group format (6 children per gorup)
arm group label: Group Intervention
criteria: 
gender: All
minimum age: 9 Years
maximum age: 12 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: National Institute on Drug Abuse (NIDA)
investigator title: Professor and Doddridge Saxon Chairholder in Clinical Psychology
mesh term: Aggression