Clinical trial NCT01720199: A School-based Prevention Intervention to Promote Wellbeing in Preadolescents
Official title: Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Risk Factors for Noncommunicable Diseases
Keywords: universal prevention
primary prevention
health promotion
wellbeing
smoking
alcohol
diet
physical activity
emotional and social skills
Lead sponsor: Azienda Sanitaria Locale CN2 Alba-Bra
Sponsor class: OTHER
Collaborators: name: University of Eastern Piedmont
name: Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
First posted: 2012-11-02
Enrollment: 2630
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a field study aiming to evaluate a school-based prevention intervention, 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).

Eligibility criteria: Inclusion Criteria:

* schools providing consensus to study participation

Exclusion Criteria:

* schools involved in structured prevention programs with similar objectives

Primary outcomes:
measure: Self-reported Social And Emotional Well-Being
timeFrame: Past 30 Days
Secondary outcomes:
measure: Self-reported Cigarette Use
timeFrame: Past 30 Days
measure: Self-reported Drunkenness Episode(s)
timeFrame: Past 30 Days
measure: Self-reported Dietary Habits
timeFrame: Past 30 Days
measure: Self-reported Frequency of Physical Exercise
timeFrame: Past 30 Days
measure: Self-reported Physical and Verbal Aggression
timeFrame: Past 30 Days
Other outcomes:
Locations:
city: Alba
country: Italy
facility: Azienda Sanitaria Locale CN2 Alba-Bra
state: Cuneo
Study officials:
affiliation: University of Eastern Piedmont
name: Fabrizio Faggiano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
name: Antonella Ermacora, MSc
role: STUDY_CHAIR
affiliation: University of Eastern Piedmont
name: Elias Allara, MD
role: STUDY_DIRECTOR
References:
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.
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.