Skip to main content
OpenTrials
Completed

NCT Number: NCT01720199

A School-based Prevention Intervention to Promote Wellbeing in Preadolescents

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Risk Factors for Noncommunicable Diseases Behavior Motor Activity Smoking Social Behavior Social Skills

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Sanitaria Locale CN2 Alba-Bra

Alba, Cuneo, 12051, Italy

About this study

Diario della Salute (DDS) is a school-based prevention intervention based on the following theories:

  • social-cognitive theory (Bandura, 1977; 1986)
  • theory of multiple intelligences (Gardner, 1987)
  • emotional intelligence theory (Goleman, 1997)
  • theory of planned behavior (Ajzen, 1991)
  • transtheoretical model of change (Prochaska, Diclemente, 1982; 1992).

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.

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • schools providing consensus to study participation

Exclusion criteria

  • schools involved in structured prevention programs with similar objectives

Treatment and study plan

Diario della Salute (DDS)

Other

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.

Primary outcomes

  1. Self-reported Social And Emotional Well-Being

    Time frame: Past 30 Days

    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 outcomes

  1. Self-reported Cigarette Use

    Time frame: Past 30 Days

    Frequency of cigarette smoking

  2. Self-reported Drunkenness Episode(s)

    Time frame: Past 30 Days

    Frequency of drunkenness episodes

  3. Self-reported Dietary Habits

    Time frame: Past 30 Days

    Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others

  4. Self-reported Frequency of Physical Exercise

    Time frame: Past 30 Days

    Frequency of moderate and heavy physical exercise

  5. Self-reported Physical and Verbal Aggression

    Time frame: Past 30 Days

    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).

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale CN2 Alba-Bra

Other

Collaborators

  • Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
  • University of Eastern Piedmont

Registry information

Official study title

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

Acronym: DDS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2012
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.