NCT01720199

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

7 months

First QC Date

October 31, 2012

Last Update Submit

January 18, 2014

Conditions

Major Risk Factors for Noncommunicable Diseases

Keywords

universal preventionprimary preventionhealth promotionwellbeingsmokingalcoholdietphysical activityemotional and social skills

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Self-reported Cigarette Use

    Past 30 Days

  • Self-reported Drunkenness Episode(s)

    Past 30 Days

  • Self-reported Dietary Habits

    Past 30 Days

  • Self-reported Frequency of Physical Exercise

    Past 30 Days

  • Self-reported Physical and Verbal Aggression

    Past 30 Days

Study Arms (2)

Intervention group

EXPERIMENTAL

Preadolescents allocated to the Diario della Salute (DDS) intervention.

Other: Diario della Salute (DDS)

Control group

NO INTERVENTION

Interventions

Diario della Salute (DDS)OTHER

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.

Intervention group

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • schools providing consensus to study participation

You may not qualify if:

  • schools involved in structured prevention programs with similar objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Sanitaria Locale CN2 Alba-Bra

Alba, Cuneo, 12051, Italy

Location

Related Publications (9)

  • Ajzen, I. (1991). The theory of planned behavior. Organizational Behavior and Human Decision Processes, 50, 179-211.

    BACKGROUND

  • Bandura, A. (1977). Social Learning Theory. New York: General Learning Press.

    BACKGROUND

  • Bandura, A. (1986). Social Foundations of Thought and Action. Englewood Cliffs, NJ: Prentice-Hall.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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: 16979751BACKGROUND

  • 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.

    BACKGROUND

  • Goleman, D. (1998). Working with emotional intelligence. New York: Bantam.

    BACKGROUND

  • 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

    BACKGROUND

  • 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: 1329589BACKGROUND

Related Links

MeSH Terms

Conditions

SmokingMotor ActivitySocial Skills

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Officials

  • Fabrizio Faggiano, MD

    University of Eastern Piedmont

    PRINCIPAL INVESTIGATOR

  • Antonella Ermacora, MSc

    Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.

    STUDY CHAIR

  • Elias Allara, MD

    University of Eastern Piedmont

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 2, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

IT(1)