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

Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)

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

Study Overview

• Status: Completed
• Conditions: Major Risk Factors for Noncommunicable Diseases
• Intervention / Treatment: Other: Diario della Salute (DDS)

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).

• Study Type: Interventional
• Enrollment (Actual): 2630
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Cuneo
    • Alba, Cuneo, Italy, 12051
      • Azienda Sanitaria Locale CN2 Alba-Bra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• schools providing consensus to study participation

Exclusion Criteria:

• schools involved in structured prevention programs with similar objectives

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group; Preadolescents allocated to the Diario della Salute (DDS) intervention.	Other: Diario della Salute (DDS); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Social And Emotional Well-Being	Subjective well-being is defined as 'a person's cognitive and affective evaluations of his or her life' (Diener, Lucas, & Oshi, 2002, p. 63).	Past 30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported Cigarette Use	Frequency of cigarette smoking	Past 30 Days
Self-reported Drunkenness Episode(s)	Frequency of drunkenness episodes	Past 30 Days
Self-reported Dietary Habits	Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others	Past 30 Days
Self-reported Frequency of Physical Exercise	Frequency of moderate and heavy physical exercise	Past 30 Days
Self-reported Physical and Verbal Aggression	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).	Past 30 Days

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale CN2 Alba-Bra
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.
• Bandura, A. (1977). Social Learning Theory. New York: General Learning Press.
• Bandura, A. (1986). Social Foundations of Thought and Action. Englewood Cliffs, NJ: Prentice-Hall.
• 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.
• 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.
• 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.
• Goleman, D. (1998). Working with emotional intelligence. New York: Bantam.
• 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

Helpful Links

• Project website (in Italian).

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 31, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 18, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: physical activity; alcohol; smoking; diet; primary prevention; health promotion; wellbeing; universal prevention; emotional and social skills
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Noncommunicable Diseases
• Other Study ID Numbers: CCM2011-CUPJ19E11002100001