<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/NCT02975544</url>
  </required_header>
  <id_info>
    <org_study_id>70801</org_study_id>
    <nct_id>NCT02975544</nct_id>
  </id_info>
  <brief_title>An Exploratory Trial of a Health Education Programme Based on the Social and Emotional Competence in Children</brief_title>
  <acronym>CRECES</acronym>
  <official_title>Pilot Study of CRECES Programme: Promoting Healthy Life Styles in Children Through the Social and Emotional Competence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundación Caja Navarra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Clinica Universidad de Navarra, Universidad de Navarra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate whether an intervention based on the social and&#xD;
      emotional competence development improves the healthy lifestyles adoption in young children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has designed, implemented and evaluated an intervention to promote healthy&#xD;
      lifestyles in children addressing the development of the social and emotional competence.&#xD;
      This research followed the first three stages of the Medical Research Council framework for&#xD;
      complex interventions: the theoretical, modeling phase and the exploratory trial. A&#xD;
      randomised control trial with 37 children (5 y 6 years old) was conducted at the exploratory&#xD;
      trial. The first unit was implemented in 8 sessions. A multi-method and multi-informant&#xD;
      approach was used to assess the preliminary efficacy, acceptability and feasibility of the&#xD;
      programme.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">April 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes on children's emotional knowledge</measure>
    <time_frame>Baseline; Post-test (1 month), 7 months follow-up</time_frame>
    <description>Directly measured on children by PERCEVAL test (Mestre, J. M., Guil, R., Martínez-Cabañas, F., Escandón, C. L., y Gonzalez de la Torre, G. (2011).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes on the total and parcial dimensions (cooperation, independence and interaction) of children's basic social skills</measure>
    <time_frame>Baseline, post-test (1 month) and 7 months follow-up</time_frame>
    <description>Reported by parents by Preschool and Kindergarten Behavior Scales (PKBS-II; Merrell, 2003).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on the total and parcial dimensions (comfort, satisfaction, resilience, risk avoidance and achievement) of children's health profile</measure>
    <time_frame>Baseline, post-test (1 month) and 7 months follow-up</time_frame>
    <description>Reported by children and parents by Child Health and Illness Profile-CHILDREN Edition (CHIP-CE; Rajmil, L., Serra-Sutton, V., Alonso, J., Herdman, M., Riley, A., y Starfield, B. (2003)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Acceptability of the programme by children and parents who took part in</measure>
    <time_frame>post-test (1 month)</time_frame>
    <description>Explored by semi-structured interviews with children and parents</description>
  </other_outcome>
  <other_outcome>
    <measure>Efficacy on children social and emotional skills and healthy habits adoption perceived by parents</measure>
    <time_frame>post-test (1 month)</time_frame>
    <description>Explored by semi-structured interviews with parents</description>
  </other_outcome>
  <other_outcome>
    <measure>Feasibility of the programme's implementation</measure>
    <time_frame>Baseline</time_frame>
    <description>Examined by researcher's field diary</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Health Behavior</condition>
  <condition>Emotional Intelligence</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received CRECES programme during 5 weeks as part of the extracurricular plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Continued with their habitual school routine</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CRECES programme</intervention_name>
    <description>The first unit of CRECES programme was implemented in 8 sessions. Each session was 40-50 minutes long and delivered during four weeks. Parents were provided with home-extension activities.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 5 and 6 enrolled in a public school in the north of Spain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with severe cognitive or language special needs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elena Bermejo Martins, Nursing, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Navarra</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinica Universidad de Navarra, Universidad de Navarra</investigator_affiliation>
    <investigator_full_name>Elena Bermejo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>social and emotional competence</keyword>
  <keyword>healthy lifestyles</keyword>
  <keyword>children</keyword>
  <keyword>educational programme</keyword>
  <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/NCT02975544
org study id: 70801
nct id: NCT02975544
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study was to evaluate whether an intervention based on the social and
      emotional competence development improves the healthy lifestyles adoption in young children.
This study has designed, implemented and evaluated an intervention to promote healthy
      lifestyles in children addressing the development of the social and emotional competence.
      This research followed the first three stages of the Medical Research Council framework for
      complex interventions: the theoretical, modeling phase and the exploratory trial. A
      randomised control trial with 37 children (5 y 6 years old) was conducted at the exploratory
      trial. The first unit was implemented in 8 sessions. A multi-method and multi-informant
      approach was used to assess the preliminary efficacy, acceptability and feasibility of the
      programme.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes on children's emotional knowledge
time frame: Baseline; Post-test (1 month), 7 months follow-up
description: Directly measured on children by PERCEVAL test (Mestre, J. M., Guil, R., Martínez-Cabañas, F., Escandón, C. L., y Gonzalez de la Torre, G. (2011).
measure: Changes on the total and parcial dimensions (cooperation, independence and interaction) of children's basic social skills
time frame: Baseline, post-test (1 month) and 7 months follow-up
description: Reported by parents by Preschool and Kindergarten Behavior Scales (PKBS-II; Merrell, 2003).
measure: Changes on the total and parcial dimensions (comfort, satisfaction, resilience, risk avoidance and achievement) of children's health profile
time frame: Baseline, post-test (1 month) and 7 months follow-up
description: Reported by children and parents by Child Health and Illness Profile-CHILDREN Edition (CHIP-CE; Rajmil, L., Serra-Sutton, V., Alonso, J., Herdman, M., Riley, A., y Starfield, B. (2003)
measure: Acceptability of the programme by children and parents who took part in
time frame: post-test (1 month)
description: Explored by semi-structured interviews with children and parents
measure: Efficacy on children social and emotional skills and healthy habits adoption perceived by parents
time frame: post-test (1 month)
description: Explored by semi-structured interviews with parents
measure: Feasibility of the programme's implementation
time frame: Baseline
description: Examined by researcher's field diary
arm group label: Intervention group
arm group type: Experimental
description: Received CRECES programme during 5 weeks as part of the extracurricular plan
arm group label: Control group
arm group type: No Intervention
description: Continued with their habitual school routine
intervention type: Behavioral
intervention name: CRECES programme
description: The first unit of CRECES programme was implemented in 8 sessions. Each session was 40-50 minutes long and delivered during four weeks. Parents were provided with home-extension activities.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elena Bermejo Martins, Nursing, PhD
role: Principal Investigator
affiliation: University of Navarra
responsible party type: Principal Investigator
investigator affiliation: Clinica Universidad de Navarra, Universidad de Navarra
investigator full name: Elena Bermejo
investigator title: Principal Investigator
sharing ipd: No