<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/NCT04414449</url>
  </required_header>
  <id_info>
    <org_study_id>PSI2017-84005-R</org_study_id>
    <nct_id>NCT04414449</nct_id>
  </id_info>
  <brief_title>ICT-enabled Social-emotional Learning: Development of Responsibility and Well-being in the Educational Environment</brief_title>
  <acronym>emoTIC</acronym>
  <official_title>ICT-enabled Social-emotional Learning: Development of Responsibility and Well-being in the Educational Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Ciencia e Innovación, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Valencia</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>
      The purpose of the study is to develop adolescents' social-emotional abilities to foster&#xD;
      their personal and social responsibility, as well as their well-being, by means of a&#xD;
      school-based intervention that addresses students, teachers and parents who participate in a&#xD;
      social-emotional program using a technological platform. The program consists of activities&#xD;
      based on solid theoretical frameworks on emotional intelligence, development of&#xD;
      responsibility and meaningful learning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      EmoTIC is an emotional education program focused on the development of social-emotional&#xD;
      competences through an application that can be used in mobile devices and tablets.The program&#xD;
      is based on a space adventure, and provides reinforcement through score points and more time&#xD;
      for the additional games. The duration of the program is 8 weeks.&#xD;
&#xD;
      The emoTIC 8 version is designed so that teachers can easily carry it out in their&#xD;
      classrooms. The application consists of application-guided activities that are put into&#xD;
      practice in class, and includes other exercises that are meant to be carried out at home. The&#xD;
      activities that are designed to be carried out during school hours are named &quot;missions&quot;, and&#xD;
      the exercises the students will do at home are called &quot;trainings&quot;. Both are essential to&#xD;
      adequately conduct the intervention.&#xD;
&#xD;
      The emoTIC SPACE version is designed so that it is carried out autonomously at home, through&#xD;
      application-guided activities. This version includes 8 activities for each of the 4 areas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emotional Intelligence</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Trait Meta-Mood Scale (TMMS-24)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Intelligence</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Trait Meta-Mood Scale (TMMS-24)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Intelligence</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Trait Meta-Mood Scale (TMMS-24)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Well-Being</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Life satisfaction and positive and negative affects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Well-Being</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Life satisfaction and positive and negative affects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Well-Being</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Life satisfaction and positive and negative affects</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Competence</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Emotional Skills and Competence Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Competence</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Emotional Skills and Competence Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional Competence</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Emotional Skills and Competence Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Somatic complaints</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>The Somatic Complain List (SCL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatic complaints</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>The Somatic Complain List (SCL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Somatic complaints</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>The Somatic Complain List (SCL-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression, Anxiety and Stress</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Depression, Anxiety and Stress Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression, Anxiety and Stress</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Depression, Anxiety and Stress Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression, Anxiety and Stress</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Depression, Anxiety and Stress Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial adjustment</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Strengths and Difficulties Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial adjustment</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Strengths and Difficulties Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial adjustment</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Strengths and Difficulties Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicide ideation</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>&quot;Sentia&quot; Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicide ideation</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>&quot;Sentia&quot; Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicide ideation</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>&quot;Sentia&quot; Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personality</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Mini-Ipip Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personality</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Mini-Ipip Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personality</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Mini-Ipip Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Rosenberg Self-Esteem Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Rosenberg Self-Esteem Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Rosenberg Self-Esteem Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>General Self-Efficacy Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>General Self-Efficacy Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>General Self-Efficacy Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School Social Climate</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Questionnaire to Assess School Social Climate (CECSCE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School Social Climate</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Questionnaire to Assess School Social Climate (CECSCE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School Social Climate</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Questionnaire to Assess School Social Climate (CECSCE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Responsibility</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Personal and Social Responsibility Questionnaire (PSRQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Responsibility</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Personal and Social Responsibility Questionnaire (PSRQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Responsibility</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Personal and Social Responsibility Questionnaire (PSRQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Happiness</measure>
    <time_frame>Time 1 (first month)</time_frame>
    <description>Subjective Happiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Happiness</measure>
    <time_frame>Time 2 (4th month)</time_frame>
    <description>Subjective Happiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Happiness</measure>
    <time_frame>Time 3 (up to 1 year)</time_frame>
    <description>Subjective Happiness Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">385</enrollment>
  <condition>Adolescent - Emotional Problem</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the tutoring time, the intervention program is carried out in the experimental group, through emoTIC. EmoTIC is an emotional education program focused on the development of social-emotional competences through an application that can be used in mobile devices and tablets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During the period in which the intervention program is conducted in the experimental group, the control group will remain in the waitlist (will not participate in the intervention), and will carry out the program once the study is finished.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ICT-enabled Social-emotional Learning</intervention_name>
    <description>ICT-enabled Social-emotional Learning</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To have signed the informed consent (or their legal tutors).&#xD;
&#xD;
          -  Being between 11 and 18 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand the activities or the language used.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Inmaculada Montoya-Castilla, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat de València</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitat de València</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>November 24, 2022</last_update_submitted>
  <last_update_submitted_qc>November 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Inmaculada Montoya Castilla</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Emotional Intelligence</keyword>
  <keyword>Schools</keyword>
  <keyword>Training Programs</keyword>
  <keyword>Information and Communication Technologies (ICT)</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/NCT04414449
org study id: PSI2017-84005-R
nct id: NCT04414449
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to develop adolescents' social-emotional abilities to foster
      their personal and social responsibility, as well as their well-being, by means of a
      school-based intervention that addresses students, teachers and parents who participate in a
      social-emotional program using a technological platform. The program consists of activities
      based on solid theoretical frameworks on emotional intelligence, development of
      responsibility and meaningful learning.
EmoTIC is an emotional education program focused on the development of social-emotional
      competences through an application that can be used in mobile devices and tablets.The program
      is based on a space adventure, and provides reinforcement through score points and more time
      for the additional games. The duration of the program is 8 weeks.

      The emoTIC 8 version is designed so that teachers can easily carry it out in their
      classrooms. The application consists of application-guided activities that are put into
      practice in class, and includes other exercises that are meant to be carried out at home. The
      activities that are designed to be carried out during school hours are named "missions", and
      the exercises the students will do at home are called "trainings". Both are essential to
      adequately conduct the intervention.

      The emoTIC SPACE version is designed so that it is carried out autonomously at home, through
      application-guided activities. This version includes 8 activities for each of the 4 areas.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Emotional Intelligence
time frame: Time 1 (first month)
description: Trait Meta-Mood Scale (TMMS-24)
measure: Emotional Intelligence
time frame: Time 2 (4th month)
description: Trait Meta-Mood Scale (TMMS-24)
measure: Emotional Intelligence
time frame: Time 3 (up to 1 year)
description: Trait Meta-Mood Scale (TMMS-24)
measure: Subjective Well-Being
time frame: Time 1 (first month)
description: Life satisfaction and positive and negative affects
measure: Subjective Well-Being
time frame: Time 2 (4th month)
description: Life satisfaction and positive and negative affects
measure: Subjective Well-Being
time frame: Time 3 (up to 1 year)
description: Life satisfaction and positive and negative affects
measure: Emotional Competence
time frame: Time 1 (first month)
description: Emotional Skills and Competence Questionnaire
measure: Emotional Competence
time frame: Time 2 (4th month)
description: Emotional Skills and Competence Questionnaire
measure: Emotional Competence
time frame: Time 3 (up to 1 year)
description: Emotional Skills and Competence Questionnaire
measure: Somatic complaints
time frame: Time 1 (first month)
description: The Somatic Complain List (SCL-10)
measure: Somatic complaints
time frame: Time 2 (4th month)
description: The Somatic Complain List (SCL-10)
measure: Somatic complaints
time frame: Time 3 (up to 1 year)
description: The Somatic Complain List (SCL-10)
measure: Depression, Anxiety and Stress
time frame: Time 1 (first month)
description: Depression, Anxiety and Stress Scale
measure: Depression, Anxiety and Stress
time frame: Time 2 (4th month)
description: Depression, Anxiety and Stress Scale
measure: Depression, Anxiety and Stress
time frame: Time 3 (up to 1 year)
description: Depression, Anxiety and Stress Scale
measure: Psychosocial adjustment
time frame: Time 1 (first month)
description: Strengths and Difficulties Questionnaire
measure: Psychosocial adjustment
time frame: Time 2 (4th month)
description: Strengths and Difficulties Questionnaire
measure: Psychosocial adjustment
time frame: Time 3 (up to 1 year)
description: Strengths and Difficulties Questionnaire
measure: Suicide ideation
time frame: Time 1 (first month)
description: "Sentia" Scale
measure: Suicide ideation
time frame: Time 2 (4th month)
description: "Sentia" Scale
measure: Suicide ideation
time frame: Time 3 (up to 1 year)
description: "Sentia" Scale
measure: Personality
time frame: Time 1 (first month)
description: Mini-Ipip Questionnaire
measure: Personality
time frame: Time 2 (4th month)
description: Mini-Ipip Questionnaire
measure: Personality
time frame: Time 3 (up to 1 year)
description: Mini-Ipip Questionnaire
measure: Self-esteem
time frame: Time 1 (first month)
description: Rosenberg Self-Esteem Scale
measure: Self-esteem
time frame: Time 2 (4th month)
description: Rosenberg Self-Esteem Scale
measure: Self-esteem
time frame: Time 3 (up to 1 year)
description: Rosenberg Self-Esteem Scale
measure: Self-Efficacy
time frame: Time 1 (first month)
description: General Self-Efficacy Scale
measure: Self-Efficacy
time frame: Time 2 (4th month)
description: General Self-Efficacy Scale
measure: Self-Efficacy
time frame: Time 3 (up to 1 year)
description: General Self-Efficacy Scale
measure: School Social Climate
time frame: Time 1 (first month)
description: Questionnaire to Assess School Social Climate (CECSCE)
measure: School Social Climate
time frame: Time 2 (4th month)
description: Questionnaire to Assess School Social Climate (CECSCE)
measure: School Social Climate
time frame: Time 3 (up to 1 year)
description: Questionnaire to Assess School Social Climate (CECSCE)
measure: Social Responsibility
time frame: Time 1 (first month)
description: Personal and Social Responsibility Questionnaire (PSRQ)
measure: Social Responsibility
time frame: Time 2 (4th month)
description: Personal and Social Responsibility Questionnaire (PSRQ)
measure: Social Responsibility
time frame: Time 3 (up to 1 year)
description: Personal and Social Responsibility Questionnaire (PSRQ)
measure: Subjective Happiness
time frame: Time 1 (first month)
description: Subjective Happiness Scale
measure: Subjective Happiness
time frame: Time 2 (4th month)
description: Subjective Happiness Scale
measure: Subjective Happiness
time frame: Time 3 (up to 1 year)
description: Subjective Happiness Scale
arm group label: Intervention group
arm group type: Experimental
description: During the tutoring time, the intervention program is carried out in the experimental group, through emoTIC. EmoTIC is an emotional education program focused on the development of social-emotional competences through an application that can be used in mobile devices and tablets.
arm group label: Control group
arm group type: No Intervention
description: During the period in which the intervention program is conducted in the experimental group, the control group will remain in the waitlist (will not participate in the intervention), and will carry out the program once the study is finished.
intervention type: Other
intervention name: ICT-enabled Social-emotional Learning
description: ICT-enabled Social-emotional Learning
arm group label: Intervention group
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Inmaculada Montoya-Castilla, PhD
role: Principal Investigator
affiliation: Universitat de València
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Inmaculada Montoya Castilla
investigator title: Associate Professor
sharing ipd: No