<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/NCT04497506</url>
  </required_header>
  <id_info>
    <org_study_id>PR[18]_SOC_0096</org_study_id>
    <nct_id>NCT04497506</nct_id>
  </id_info>
  <brief_title>Wise Interventions in the Digital Society</brief_title>
  <official_title>Wise Interventions for Adolescents and Young People in the Digital Society</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Deusto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundación BBVA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Deusto</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 study evaluates the effectiveness of a Wise intervention based on self-affirmation (SA)&#xD;
      and Implicit Theories of Personality (ITP) in Spanish adolescents and young people. Half of&#xD;
      participants will receive the ITP and self-affirmation intervention, while the other half&#xD;
      will receive a control intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescence is a period that involves important transitions and learning opportunities.&#xD;
      Adolescents and young people learn and develop new competencies and facets in the digital&#xD;
      society. Hence, a large part of their social relationships takes place through social&#xD;
      media.This offers them numerous positive opportunities for the emotional and social&#xD;
      development of adolescents and young people. They can develop positive interactions through&#xD;
      prosocial behaviors, empathy, and social support towards others. At the same time it is not&#xD;
      without potential risks, especially in adolescence, a stage of psychological vulnerability&#xD;
      for risky behaviors. Very recently, interest in scientific social psychology has grown due to&#xD;
      a new approach to interventions, which have been called &quot;wise interventions.&quot; This approach&#xD;
      involves a set of rigorous techniques, based on theory and research, that address specific&#xD;
      psychological processes to help people thrive in various life environments. The main&#xD;
      objective of this project is to design and evaluate the effectiveness of a wise intervention&#xD;
      based on self-affirmation (SA) and Implicit Theories of Personality (ITP) to promote various&#xD;
      online prosocial behaviors (help, empathy, collaboration) and prevent online risk and&#xD;
      harassment behaviors (online bullying, sexting, grooming). Secondary objectives are (1) to&#xD;
      assess the moderating role of gender and the degree of evolutionary development of&#xD;
      adolescents and young people, and (2) to evaluate potential mediating mechanisms for the&#xD;
      effectiveness of the interventions. The study will involve the evaluation of the intervention&#xD;
      in a sample of around 1000 young and adolescents randomly allocated to experimental and&#xD;
      control condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2021</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>
    <intervention_model_description>Participants will be randomized in a 1:1 ratio blocked by gender to one of two groups: experimental condition (SA+ITP) versus control condition (anti-stress condition) in parallel for the duration of the study.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Allocation will be concealed to the participants, researchers -who will be in class the assessment days if possible depending on the Covid-19 scenario- and teachers.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline scores of the Cyber Bullying Questionnaire (CBQ; Calvete et al., 2010; Gámez-Guadix, Villa-George, &amp; Calvete, 2014)</measure>
    <time_frame>Baseline, 3 months, and 6 months.</time_frame>
    <description>Self reported levels of perpetration (9 items) and victimization (9 items) of peer cyber aggression. Each item is scored 0-4 (0 = never; 4 = almost every week).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline scores of the Online Sexual Solicitation and Interaction of Minors with Adults Questionnaire (Gámez-Guadix, De Santisteban, &amp; Alcazar, 2017).</measure>
    <time_frame>Baseline, 3 months, and 6 months.</time_frame>
    <description>Self reported items that assess the sexual interactions with an adult (10 items). Items are rated on a four-point response scale ranging from 0 (never) to 3 (6 or more times).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline scores of the Sexting questionnaire (Gámez-Guadix, Almendros, Borrajo, &amp; Calvete, 2015).</measure>
    <time_frame>Baseline, 3 months, and 6 months.</time_frame>
    <description>Self reported items about sending photos, information or videos of sexual or intimate content to three potential recipients: a partner, a friend and someone they have met on Internet but not in person (3 items). A five-point response scale was used ranging from 0 (never) to 4 (7 or more times).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline scores of the Online Prosocial Behavior Scale (OPBS; Erreygers, Vandebosch, Vranjes, Baillien y De Witte, 2017).</measure>
    <time_frame>Baseline, 3 months, and 6 months.</time_frame>
    <description>Self reported items about online prosocial behaviors (4 items). A five-point response scale was used ranging from 1 (never) to 5 (every day).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline scores of the Cyber Dating Abuse Questionnaire (CDAQ; Borrajo et al., 2015)</measure>
    <time_frame>Baseline, 3 months, and 6 months (only in participants with a dating relationship).</time_frame>
    <description>Self reported items about dating aggressive behaviors of perpetration (4 items) and victimization (4 items). Items scored 0-3 (0 = never; 3 = almost always).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline scores of the reduced version of the Center for Epidemiological Studies Depression (CES-D; Rueda-Jaimes et al., 2009).</measure>
    <time_frame>Baseline, 3 months, and 6 months.</time_frame>
    <description>Self reported symptoms of depression through 10 items, with a four-point response scale ranging from 0 (practically never) to 3 (almost all the time).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline scores of attitude towards cyberbullying measure</measure>
    <time_frame>Baseline, intervention day, 3 months, and 6 months.</time_frame>
    <description>Self reported ad hoc measures developed by the research team of the attitude towards cyberbullying. The participants will classify one situation of cyberbullying through adjectives using the semantic differential technique with a response range of 7 points.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline scores of attitude towards different courses of action measure</measure>
    <time_frame>Baseline, intervention day, 3 months, and 6 months.</time_frame>
    <description>Self reported ad hoc measures developed by the research team of the attitude towards different courses of action when the adolescent witnesses cyberbullying. The participants will rate four different ways to react to cyberbullying through semantic differential items.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline scores of the anticipation of reactions and behaviors measure</measure>
    <time_frame>Baseline, intervention day, 3 months, and 6 months.</time_frame>
    <description>Self reported ad hoc measures developed by the research team of the anticipation of reactions and behaviors when the adolescent is a witness. The participants will answer seven items on a five-point response scale ranging from 0 (totally disagree) to 3 (totally agree).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline scores of Entity and incremental theories (Levy, Stroessner, &amp; Dweck, 1998).</measure>
    <time_frame>Baseline, intervention day, 3 months, and 6 months.</time_frame>
    <description>Entity and incremental theories will be evaluated using eight items adapted to the situations of bullying in schools. Items are rated on a six-point scale ranging from 1 (strongly disagree) to 6 (strongly agree).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1212</enrollment>
  <condition>Cyberbullying</condition>
  <condition>Grooming</condition>
  <condition>Risk Behavior</condition>
  <arm_group>
    <arm_group_label>Self-affirmation and Incremental theory of personality</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 hour Wise intervention (based on SA and ITP) consisting on several tasks to be completed online individually.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard preventive intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>1 hour educational intervention (about stress management) consisting on several tasks to be completed online individually.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wise Intervention (Self-affirmation and Incremental theory of personality)</intervention_name>
    <description>The intervention designed to promote prosocial behavior and reduce online risks is based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. It includes two components: a self-affirmation activity and an ITP intervention. The SA component includes a list of values so that they could choose the two or three most important for them. Next, they are asked to write why those selected values are the most important to them. The ITP component includes activities such as reading scientific information about social behavior and its role in people's well-being, the meaning and value of online risk behaviors through stories and videos of the experiences of other young people of their age, and self-persuasion exercises that involve an active commitment to change.</description>
    <arm_group_label>Self-affirmation and Incremental theory of personality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard preventive intervention</intervention_name>
    <description>It consists of an educational intervention that provides a number of strategies to manage everyday conflicts among adolescents. This intervention teaches them new ways to manage these difficulties through different actions (relaxation, distraction, sports, etc.). Finally, they are asked to plan the strategies they will use in the future in the face of some difficulties and to recommend some guidelines for another adolescent who may be going through a similar situation.</description>
    <arm_group_label>Standard preventive intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent by the adolescents and their parents.&#xD;
&#xD;
          -  To be fluent in Spanish and/or Euskera.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of permission by parents and the adolescent.&#xD;
&#xD;
          -  Lack of understanding of the instructions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esther Calvete, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Deusto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Deusto</name>
      <address>
        <city>Bilbao</city>
        <state>Bizkaia</state>
        <zip>48080</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Deusto</investigator_affiliation>
    <investigator_full_name>Esther Calvete</investigator_full_name>
    <investigator_title>Principal Investigator, Deusto Stress Research Team, University of Deusto</investigator_title>
  </responsible_party>
  <keyword>Adolescence</keyword>
  <keyword>Youth</keyword>
  <keyword>Cyberbullying</keyword>
  <keyword>Grooming</keyword>
  <keyword>Sexting</keyword>
  <keyword>Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyberbullying</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Raw data will be available at OSF when the results of the study are published.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>The study protocol and informed consent protocol will be published at clinicaltrials.org Data will be available at OSF when the results are published.</ipd_time_frame>
    <ipd_access_criteria>Public</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT04497506/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT04497506/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04497506
org study id: PR[18]_SOC_0096
nct id: NCT04497506
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effectiveness of a Wise intervention based on self-affirmation (SA)
      and Implicit Theories of Personality (ITP) in Spanish adolescents and young people. Half of
      participants will receive the ITP and self-affirmation intervention, while the other half
      will receive a control intervention.
Adolescence is a period that involves important transitions and learning opportunities.
      Adolescents and young people learn and develop new competencies and facets in the digital
      society. Hence, a large part of their social relationships takes place through social
      media.This offers them numerous positive opportunities for the emotional and social
      development of adolescents and young people. They can develop positive interactions through
      prosocial behaviors, empathy, and social support towards others. At the same time it is not
      without potential risks, especially in adolescence, a stage of psychological vulnerability
      for risky behaviors. Very recently, interest in scientific social psychology has grown due to
      a new approach to interventions, which have been called "wise interventions." This approach
      involves a set of rigorous techniques, based on theory and research, that address specific
      psychological processes to help people thrive in various life environments. The main
      objective of this project is to design and evaluate the effectiveness of a wise intervention
      based on self-affirmation (SA) and Implicit Theories of Personality (ITP) to promote various
      online prosocial behaviors (help, empathy, collaboration) and prevent online risk and
      harassment behaviors (online bullying, sexting, grooming). Secondary objectives are (1) to
      assess the moderating role of gender and the degree of evolutionary development of
      adolescents and young people, and (2) to evaluate potential mediating mechanisms for the
      effectiveness of the interventions. The study will involve the evaluation of the intervention
      in a sample of around 1000 young and adolescents randomly allocated to experimental and
      control condition.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized in a 1:1 ratio blocked by gender to one of two groups: experimental condition (SA+ITP) versus control condition (anti-stress condition) in parallel for the duration of the study.
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: Allocation will be concealed to the participants, researchers -who will be in class the assessment days if possible depending on the Covid-19 scenario- and teachers.
measure: Change from baseline scores of the Cyber Bullying Questionnaire (CBQ; Calvete et al., 2010; Gámez-Guadix, Villa-George, & Calvete, 2014)
time frame: Baseline, 3 months, and 6 months.
description: Self reported levels of perpetration (9 items) and victimization (9 items) of peer cyber aggression. Each item is scored 0-4 (0 = never; 4 = almost every week).
measure: Change from baseline scores of the Online Sexual Solicitation and Interaction of Minors with Adults Questionnaire (Gámez-Guadix, De Santisteban, & Alcazar, 2017).
time frame: Baseline, 3 months, and 6 months.
description: Self reported items that assess the sexual interactions with an adult (10 items). Items are rated on a four-point response scale ranging from 0 (never) to 3 (6 or more times).
measure: Change from baseline scores of the Sexting questionnaire (Gámez-Guadix, Almendros, Borrajo, & Calvete, 2015).
time frame: Baseline, 3 months, and 6 months.
description: Self reported items about sending photos, information or videos of sexual or intimate content to three potential recipients: a partner, a friend and someone they have met on Internet but not in person (3 items). A five-point response scale was used ranging from 0 (never) to 4 (7 or more times).
measure: Change from baseline scores of the Online Prosocial Behavior Scale (OPBS; Erreygers, Vandebosch, Vranjes, Baillien y De Witte, 2017).
time frame: Baseline, 3 months, and 6 months.
description: Self reported items about online prosocial behaviors (4 items). A five-point response scale was used ranging from 1 (never) to 5 (every day).
measure: Change from baseline scores of the Cyber Dating Abuse Questionnaire (CDAQ; Borrajo et al., 2015)
time frame: Baseline, 3 months, and 6 months (only in participants with a dating relationship).
description: Self reported items about dating aggressive behaviors of perpetration (4 items) and victimization (4 items). Items scored 0-3 (0 = never; 3 = almost always).
measure: Change from baseline scores of the reduced version of the Center for Epidemiological Studies Depression (CES-D; Rueda-Jaimes et al., 2009).
time frame: Baseline, 3 months, and 6 months.
description: Self reported symptoms of depression through 10 items, with a four-point response scale ranging from 0 (practically never) to 3 (almost all the time).
measure: Change from baseline scores of attitude towards cyberbullying measure
time frame: Baseline, intervention day, 3 months, and 6 months.
description: Self reported ad hoc measures developed by the research team of the attitude towards cyberbullying. The participants will classify one situation of cyberbullying through adjectives using the semantic differential technique with a response range of 7 points.
measure: Change from baseline scores of attitude towards different courses of action measure
time frame: Baseline, intervention day, 3 months, and 6 months.
description: Self reported ad hoc measures developed by the research team of the attitude towards different courses of action when the adolescent witnesses cyberbullying. The participants will rate four different ways to react to cyberbullying through semantic differential items.
measure: Change from baseline scores of the anticipation of reactions and behaviors measure
time frame: Baseline, intervention day, 3 months, and 6 months.
description: Self reported ad hoc measures developed by the research team of the anticipation of reactions and behaviors when the adolescent is a witness. The participants will answer seven items on a five-point response scale ranging from 0 (totally disagree) to 3 (totally agree).
measure: Change from baseline scores of Entity and incremental theories (Levy, Stroessner, & Dweck, 1998).
time frame: Baseline, intervention day, 3 months, and 6 months.
description: Entity and incremental theories will be evaluated using eight items adapted to the situations of bullying in schools. Items are rated on a six-point scale ranging from 1 (strongly disagree) to 6 (strongly agree).
arm group label: Self-affirmation and Incremental theory of personality
arm group type: Experimental
description: 1 hour Wise intervention (based on SA and ITP) consisting on several tasks to be completed online individually.
arm group label: Standard preventive intervention
arm group type: Other
description: 1 hour educational intervention (about stress management) consisting on several tasks to be completed online individually.
intervention type: Behavioral
intervention name: Wise Intervention (Self-affirmation and Incremental theory of personality)
description: The intervention designed to promote prosocial behavior and reduce online risks is based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. It includes two components: a self-affirmation activity and an ITP intervention. The SA component includes a list of values so that they could choose the two or three most important for them. Next, they are asked to write why those selected values are the most important to them. The ITP component includes activities such as reading scientific information about social behavior and its role in people's well-being, the meaning and value of online risk behaviors through stories and videos of the experiences of other young people of their age, and self-persuasion exercises that involve an active commitment to change.
arm group label: Self-affirmation and Incremental theory of personality
intervention type: Behavioral
intervention name: Standard preventive intervention
description: It consists of an educational intervention that provides a number of strategies to manage everyday conflicts among adolescents. This intervention teaches them new ways to manage these difficulties through different actions (relaxation, distraction, sports, etc.). Finally, they are asked to plan the strategies they will use in the future in the face of some difficulties and to recommend some guidelines for another adolescent who may be going through a similar situation.
arm group label: Standard preventive intervention
criteria: 
gender: All
minimum age: 11 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Esther Calvete, PhD
role: Principal Investigator
affiliation: University of Deusto
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Deusto
investigator full name: Esther Calvete
investigator title: Principal Investigator, Deusto Stress Research Team, University of Deusto
mesh term: Cyberbullying
sharing ipd: Yes
ipd description: Raw data will be available at OSF when the results of the study are published.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: The study protocol and informed consent protocol will be published at clinicaltrials.org Data will be available at OSF when the results are published.
ipd access criteria: Public
provided document: 
provided document: 