A School-based Prevention Intervention to Promote Wellbeing in Preadolescents

Major Risk Factors for Noncommunicable Diseases Clinical Trial

— DDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720199
• Other study ID #: CCM2011-CUPJ19E11002100001
• Status: Completed
• Phase: N/A
• First received: October 31, 2012
• Last updated: January 18, 2014
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Azienda Sanitaria Locale CN2 Alba-Bra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2630
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 15 Years

Eligibility

Inclusion Criteria:

• schools providing consensus to study participation

Exclusion Criteria:

• schools involved in structured prevention programs with similar objectives

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Major Risk Factors for Noncommunicable Diseases

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.

Locations

Country	Name	City	State
Italy	Azienda Sanitaria Locale CN2 Alba-Bra	Alba	Cuneo

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale CN2 Alba-Bra	Eclectica Sas di Beccaria Franca, Ermacora Antonella e C., University of Eastern Piedmont

Country where clinical trial is conducted

Italy, 

References & Publications (9)

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. Epub 2006 Sep 18. — View 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.

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

Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Self-reported Cigarette Use	Frequency of cigarette smoking	Past 30 Days	No
Secondary	Self-reported Drunkenness Episode(s)	Frequency of drunkenness episodes	Past 30 Days	No
Secondary	Self-reported Dietary Habits	Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others	Past 30 Days	No
Secondary	Self-reported Frequency of Physical Exercise	Frequency of moderate and heavy physical exercise	Past 30 Days	No
Secondary	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	No

External Links

•   Project website (in Italian).