A School-based Prevention Intervention to Promote Wellbeing in Preadolescents (DDS)

This study has been completed.
Sponsor:
Collaborators:
University of Eastern Piedmont
Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
Information provided by (Responsible Party):
Azienda Sanitaria Locale CN2 Alba-Bra
ClinicalTrials.gov Identifier:
NCT01720199
First received: October 31, 2012
Last updated: January 18, 2014
Last verified: January 2014
  Purpose

This is a field study aiming to evaluate a school-based prevention intervention, Diario della Salute (DDS).


Condition Intervention
Major Risk Factors for Noncommunicable Diseases
Other: Diario della Salute (DDS)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)

Resource links provided by NLM:


Further study details as provided by Azienda Sanitaria Locale CN2 Alba-Bra:

Primary Outcome Measures:
  • Self-reported Social And Emotional Well-Being [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]
    Subjective well-being is defined as 'a person's cognitive and affective evaluations of his or her life' (Diener, Lucas, & Oshi, 2002, p. 63).


Secondary Outcome Measures:
  • Self-reported Cigarette Use [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]
    Frequency of cigarette smoking

  • Self-reported Drunkenness Episode(s) [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]
    Frequency of drunkenness episodes

  • Self-reported Dietary Habits [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]
    Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others

  • Self-reported Frequency of Physical Exercise [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]
    Frequency of moderate and heavy physical exercise

  • Self-reported Physical and Verbal Aggression [ Time Frame: Past 30 Days ] [ Designated as safety issue: No ]
    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).


Enrollment: 2630
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention group
Preadolescents allocated to the Diario della Salute (DDS) intervention.
Other: Diario della Salute (DDS)

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.
No Intervention: Control group

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • schools providing consensus to study participation

Exclusion Criteria:

  • schools involved in structured prevention programs with similar objectives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720199

Locations
Italy
Azienda Sanitaria Locale CN2 Alba-Bra
Alba, Cuneo, Italy, 12051
Sponsors and Collaborators
Azienda Sanitaria Locale CN2 Alba-Bra
University of Eastern Piedmont
Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
Investigators
Principal Investigator: Fabrizio Faggiano, MD University of Eastern Piedmont
Study Chair: Antonella Ermacora, MSc Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
Study Director: Elias Allara, MD University of Eastern Piedmont
  More Information

Additional Information:
Publications:
Responsible Party: Azienda Sanitaria Locale CN2 Alba-Bra
ClinicalTrials.gov Identifier: NCT01720199     History of Changes
Other Study ID Numbers: CCM2011-CUPJ19E11002100001
Study First Received: October 31, 2012
Last Updated: January 18, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Sanitaria Locale CN2 Alba-Bra:
universal prevention
primary prevention
health promotion
wellbeing
smoking
alcohol
diet
physical activity
emotional and social skills

ClinicalTrials.gov processed this record on August 26, 2014