<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/NCT01720199</url>
  </required_header>
  <id_info>
    <org_study_id>CCM2011-CUPJ19E11002100001</org_study_id>
    <nct_id>NCT01720199</nct_id>
  </id_info>
  <brief_title>A School-based Prevention Intervention to Promote Wellbeing in Preadolescents</brief_title>
  <acronym>DDS</acronym>
  <official_title>Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Sanitaria Locale CN2 Alba-Bra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Eastern Piedmont</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Sanitaria Locale CN2 Alba-Bra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a field study aiming to evaluate a school-based prevention intervention, Diario della&#xD;
      Salute (DDS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diario della Salute (DDS) is a school-based prevention intervention based on the following&#xD;
      theories:&#xD;
&#xD;
        1. social-cognitive theory (Bandura, 1977; 1986)&#xD;
&#xD;
        2. theory of multiple intelligences (Gardner, 1987)&#xD;
&#xD;
        3. emotional intelligence theory (Goleman, 1997)&#xD;
&#xD;
        4. theory of planned behavior (Ajzen, 1991)&#xD;
&#xD;
        5. transtheoretical model of change (Prochaska, Diclemente, 1982; 1992).&#xD;
&#xD;
      DDS is composed by:&#xD;
&#xD;
        1. tools for children and their parents on health and social and emotional well-being&#xD;
           issues:&#xD;
&#xD;
             1. a diary for teens telling the story of four same-age students (e.g. experimenting&#xD;
                with risky behaviors, conflicting feelings and thoughts, need for independence and&#xD;
                control),&#xD;
&#xD;
             2. a diary for parents telling the experience of a mum and a dad with teenage children&#xD;
                (e.g. problems in the relationship with teenage children, family conflict, parental&#xD;
                disappointment, etc.);&#xD;
&#xD;
        2. five highly-standardized interactive lessons (2-4 hours each) on health issues&#xD;
           administered by previously trained teachers.&#xD;
&#xD;
      Assignment of schools to study arms (DDS intervention vs. no intervention) will be&#xD;
      cluster-randomized. Schools will be matched by number of students and average socioeconomic&#xD;
      status. In some study areas schools will not be allocated by chance, but they will be&#xD;
      analyzed separately from other schools.&#xD;
&#xD;
      Two anonymous surveys focusing on main outcomes (wellbeing, tobacco smoking, alcohol,&#xD;
      physical activity and diet) will be before and after the intervention. Pre and post surveys&#xD;
      will be linked through an anonymous code (Galanti, 2006).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported Social And Emotional Well-Being</measure>
    <time_frame>Past 30 Days</time_frame>
    <description>Subjective well-being is defined as 'a person's cognitive and affective evaluations of his or her life' (Diener, Lucas, &amp; Oshi, 2002, p. 63).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported Cigarette Use</measure>
    <time_frame>Past 30 Days</time_frame>
    <description>Frequency of cigarette smoking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Drunkenness Episode(s)</measure>
    <time_frame>Past 30 Days</time_frame>
    <description>Frequency of drunkenness episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Dietary Habits</measure>
    <time_frame>Past 30 Days</time_frame>
    <description>Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Frequency of Physical Exercise</measure>
    <time_frame>Past 30 Days</time_frame>
    <description>Frequency of moderate and heavy physical exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Physical and Verbal Aggression</measure>
    <time_frame>Past 30 Days</time_frame>
    <description>Aggression is generally defined as behaviors that are intended to hurt or harm others by damaging their physical and psychological well-being and includes physically and verbally aggressive behaviors such as hitting, pushing, kicking, and threatening, etc (Dodge et al. 2007).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2630</enrollment>
  <condition>Major Risk Factors for Noncommunicable Diseases</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preadolescents allocated to the Diario della Salute (DDS) intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diario della Salute (DDS)</intervention_name>
    <description>DDS is composed by&#xD;
tools for children and their parents on health and social and emotional well-being issues:&#xD;
a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control),&#xD;
a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.);&#xD;
five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  schools providing consensus to study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  schools involved in structured prevention programs with similar objectives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabrizio Faggiano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Eastern Piedmont</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonella Ermacora, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elias Allara, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Eastern Piedmont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Sanitaria Locale CN2 Alba-Bra</name>
      <address>
        <city>Alba</city>
        <state>Cuneo</state>
        <zip>12051</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.diariodellasalute.it/</url>
    <description>Project website (in Italian).</description>
  </link>
  <reference>
    <citation>Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.</citation>
  </reference>
  <reference>
    <citation>Bandura, A. (1977). Social Learning Theory. New York: General Learning Press.</citation>
  </reference>
  <reference>
    <citation>Bandura, A. (1986). Social Foundations of Thought and Action. Englewood Cliffs, NJ: Prentice-Hall.</citation>
  </reference>
  <reference>
    <citation>Dodge, K.A., Coie, J.D., &amp; Lynam, D. (2006). Aggression and antisocial behavior in youth. In W. Damon (Series Ed.), &amp; N. Eisenberg (Vol. Ed.) (Ed.). Handbook of Child Psychology, Vol. 3: Social, Emotional, and Personality Development6th edition (pp. 719-788). Wiley.</citation>
  </reference>
  <reference>
    <citation>Galanti MR, Siliquini R, Cuomo L, Melero JC, Panella M, Faggiano F; EU-DAP study group. Testing anonymous link procedures for follow-up of adolescents in a school-based trial: the EU-DAP pilot study. Prev Med. 2007 Feb;44(2):174-7. doi: 10.1016/j.ypmed.2006.07.019. Epub 2006 Sep 18.</citation>
    <PMID>16979751</PMID>
  </reference>
  <reference>
    <citation>Gardner, H. (1987). Beyond a modular view of mind. In W. Damon (Ed.), New Directions for Child Development, Tenth Anniversary Edition. Also in W. Damon (Ed.) (1988), Child Development Today and Tomorrow (222-239). San Francisco: Jossey-Bass.</citation>
  </reference>
  <reference>
    <citation>Goleman, D. (1998). Working with emotional intelligence. New York: Bantam.</citation>
  </reference>
  <reference>
    <citation>Prochaska J.O. and DiClemente C.C. (1982). Trans-theoretical therapy - toward a more integrative model of change. Psychotherapy: Theory, Research and Practice 19(3):276-288</citation>
  </reference>
  <reference>
    <citation>Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. doi: 10.1037//0003-066x.47.9.1102.</citation>
    <PMID>1329589</PMID>
  </reference>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>January 18, 2014</last_update_submitted>
  <last_update_submitted_qc>January 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>universal prevention</keyword>
  <keyword>primary prevention</keyword>
  <keyword>health promotion</keyword>
  <keyword>wellbeing</keyword>
  <keyword>smoking</keyword>
  <keyword>alcohol</keyword>
  <keyword>diet</keyword>
  <keyword>physical activity</keyword>
  <keyword>emotional and social skills</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Noncommunicable Diseases</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/NCT01720199
org study id: CCM2011-CUPJ19E11002100001
nct id: NCT01720199
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is a field study aiming to evaluate a school-based prevention intervention, Diario della
      Salute (DDS).
Diario della Salute (DDS) is a school-based prevention intervention based on the following
      theories:

        1. social-cognitive theory (Bandura, 1977; 1986)

        2. theory of multiple intelligences (Gardner, 1987)

        3. emotional intelligence theory (Goleman, 1997)

        4. theory of planned behavior (Ajzen, 1991)

        5. transtheoretical model of change (Prochaska, Diclemente, 1982; 1992).

      DDS is composed by:

        1. tools for children and their parents on health and social and emotional well-being
           issues:

             1. a diary for teens telling the story of four same-age students (e.g. experimenting
                with risky behaviors, conflicting feelings and thoughts, need for independence and
                control),

             2. a diary for parents telling the experience of a mum and a dad with teenage children
                (e.g. problems in the relationship with teenage children, family conflict, parental
                disappointment, etc.);

        2. five highly-standardized interactive lessons (2-4 hours each) on health issues
           administered by previously trained teachers.

      Assignment of schools to study arms (DDS intervention vs. no intervention) will be
      cluster-randomized. Schools will be matched by number of students and average socioeconomic
      status. In some study areas schools will not be allocated by chance, but they will be
      analyzed separately from other schools.

      Two anonymous surveys focusing on main outcomes (wellbeing, tobacco smoking, alcohol,
      physical activity and diet) will be before and after the intervention. Pre and post surveys
      will be linked through an anonymous code (Galanti, 2006).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Self-reported Social And Emotional Well-Being
time frame: Past 30 Days
description: Subjective well-being is defined as 'a person's cognitive and affective evaluations of his or her life' (Diener, Lucas, & Oshi, 2002, p. 63).
measure: Self-reported Cigarette Use
time frame: Past 30 Days
description: Frequency of cigarette smoking
measure: Self-reported Drunkenness Episode(s)
time frame: Past 30 Days
description: Frequency of drunkenness episodes
measure: Self-reported Dietary Habits
time frame: Past 30 Days
description: Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others
measure: Self-reported Frequency of Physical Exercise
time frame: Past 30 Days
description: Frequency of moderate and heavy physical exercise
measure: Self-reported Physical and Verbal Aggression
time frame: Past 30 Days
description: Aggression is generally defined as behaviors that are intended to hurt or harm others by damaging their physical and psychological well-being and includes physically and verbally aggressive behaviors such as hitting, pushing, kicking, and threatening, etc (Dodge et al. 2007).
arm group label: Intervention group
arm group type: Experimental
description: Preadolescents allocated to the Diario della Salute (DDS) intervention.
arm group label: Control group
arm group type: No Intervention
intervention type: Other
intervention name: Diario della Salute (DDS)
description: DDS is composed by
tools for children and their parents on health and social and emotional well-being issues:
a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control),
a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.);
five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 11 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fabrizio Faggiano, MD
role: Principal Investigator
affiliation: University of Eastern Piedmont
last name: Antonella Ermacora, MSc
role: Study Chair
affiliation: Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
last name: Elias Allara, MD
role: Study Director
affiliation: University of Eastern Piedmont
facility: 
country: Italy
url: http://www.diariodellasalute.it/
description: Project website (in Italian).
citation: Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.
citation: Bandura, A. (1977). Social Learning Theory. New York: General Learning Press.
citation: Bandura, A. (1986). Social Foundations of Thought and Action. Englewood Cliffs, NJ: Prentice-Hall.
citation: Dodge, K.A., Coie, J.D., & Lynam, D. (2006). Aggression and antisocial behavior in youth. In W. Damon (Series Ed.), & N. Eisenberg (Vol. Ed.) (Ed.). Handbook of Child Psychology, Vol. 3: Social, Emotional, and Personality Development6th edition (pp. 719-788). Wiley.
citation: Galanti MR, Siliquini R, Cuomo L, Melero JC, Panella M, Faggiano F; EU-DAP study group. Testing anonymous link procedures for follow-up of adolescents in a school-based trial: the EU-DAP pilot study. Prev Med. 2007 Feb;44(2):174-7. doi: 10.1016/j.ypmed.2006.07.019. Epub 2006 Sep 18.
PMID: 16979751
citation: Gardner, H. (1987). Beyond a modular view of mind. In W. Damon (Ed.), New Directions for Child Development, Tenth Anniversary Edition. Also in W. Damon (Ed.) (1988), Child Development Today and Tomorrow (222-239). San Francisco: Jossey-Bass.
citation: Goleman, D. (1998). Working with emotional intelligence. New York: Bantam.
citation: Prochaska J.O. and DiClemente C.C. (1982). Trans-theoretical therapy - toward a more integrative model of change. Psychotherapy: Theory, Research and Practice 19(3):276-288
citation: Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. doi: 10.1037//0003-066x.47.9.1102.
PMID: 1329589
responsible party type: Sponsor
mesh term: Noncommunicable Diseases