<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/NCT03004781</url>
  </required_header>
  <id_info>
    <org_study_id>UCLouvain_H2M1</org_study_id>
    <nct_id>NCT03004781</nct_id>
  </id_info>
  <brief_title>Stimulation of Parents' Self-efficacy Beliefs and Emotion Coaching Practices (H2M1)</brief_title>
  <acronym>H2M1</acronym>
  <official_title>Stimulation of Parents' Self-efficacy Beliefs and Emotion Coaching Practices to Reduce Externalizing Behavior in Preschoolers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research compared the efficacy of two parenting interventions that vary according to the&#xD;
      number and the nature of variables in reducing preschoolers' externalizing behavior (EB). The&#xD;
      goal was to identify which parenting intervention format (one-variable versus two-variable)&#xD;
      caused higher behavioral adjustment in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first format was a one-variable intervention manipulating parental self-efficacy beliefs.&#xD;
      The second format was a two-variable intervention manipulating both parents' self-efficacy&#xD;
      beliefs and emotion coaching practices. The two interventions shared exactly the same design,&#xD;
      consisting of eight parent group sessions. Effect on children's EB and observed behaviors&#xD;
      were evaluated through a multi-method assessment at three points (pre-test, post-test and&#xD;
      follow-up).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in child behavior</measure>
    <time_frame>0 week, 8 weeks, 24 weeks</time_frame>
    <description>parent reports of child behavior and standardized observation of parent-child interaction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in parental self-efficacy beliefs</measure>
    <time_frame>0 week, 8 weeks, 24 weeks</time_frame>
    <description>parent questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parenting behavior</measure>
    <time_frame>0 week, 8 weeks, 24 weeks</time_frame>
    <description>standardized observation of parent-child interaction</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Behavior Problem</condition>
  <arm_group>
    <arm_group_label>Waiting-list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>8-week period without intervention, N=45</description>
  </arm_group>
  <arm_group>
    <arm_group_label>self-efficacy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week group-based parenting program on self-efficacy beliefs, N=19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>self-efficacy/emotion coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week group-based parenting program on self-efficacy beliefs and emotion coaching practice, N=26</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parenting program</intervention_name>
    <arm_group_label>self-efficacy</arm_group_label>
    <arm_group_label>self-efficacy/emotion coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children in the clinical or borderline range of the EB scale (cut-off = 21 or higher)&#xD;
             of the Child Behavior Checklist preschool form (Achenbach &amp; Rescorla, 2000a)&#xD;
&#xD;
          -  three to six years old and still in kindergarten at the beginning of the intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with intellectual disabilities (average IQ &lt; 5.5)&#xD;
&#xD;
          -  highly gifted children (average IQ &gt;14.5)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université Catholique de Louvain</investigator_affiliation>
    <investigator_full_name>Isabelle Roskam</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>parenting intervention</keyword>
  <keyword>externalizing behavior</keyword>
  <keyword>emotion coaching practices</keyword>
  <keyword>self-efficacy beliefs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</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/NCT03004781
org study id: UCLouvain_H2M1
nct id: NCT03004781
lead sponsor: 
has dmc: No
This research compared the efficacy of two parenting interventions that vary according to the
      number and the nature of variables in reducing preschoolers' externalizing behavior (EB). The
      goal was to identify which parenting intervention format (one-variable versus two-variable)
      caused higher behavioral adjustment in children.
The first format was a one-variable intervention manipulating parental self-efficacy beliefs.
      The second format was a two-variable intervention manipulating both parents' self-efficacy
      beliefs and emotion coaching practices. The two interventions shared exactly the same design,
      consisting of eight parent group sessions. Effect on children's EB and observed behaviors
      were evaluated through a multi-method assessment at three points (pre-test, post-test and
      follow-up).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in child behavior
time frame: 0 week, 8 weeks, 24 weeks
description: parent reports of child behavior and standardized observation of parent-child interaction
measure: Change in parental self-efficacy beliefs
time frame: 0 week, 8 weeks, 24 weeks
description: parent questionnaire
measure: Change in parenting behavior
time frame: 0 week, 8 weeks, 24 weeks
description: standardized observation of parent-child interaction
arm group label: Waiting-list
arm group type: No Intervention
description: 8-week period without intervention, N=45
arm group label: self-efficacy
arm group type: Experimental
description: 8-week group-based parenting program on self-efficacy beliefs, N=19
arm group label: self-efficacy/emotion coaching
arm group type: Experimental
description: 8-week group-based parenting program on self-efficacy beliefs and emotion coaching practice, N=26
intervention type: Behavioral
intervention name: Parenting program
arm group label: self-efficacy
arm group label: self-efficacy/emotion coaching
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Université Catholique de Louvain
investigator full name: Isabelle Roskam
investigator title: Professor
mesh term: Problem Behavior
sharing ipd: No