A School-based Prevention Intervention to Promote Wellbeing in Preadolescents

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

Detailed Description
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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).

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

Conditions
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Major Risk Factors for Noncommunicable Diseases

Intervention / Treatment
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* Other: Diario della Salute (DDS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: schools providing consensus to study participation Exclusion Criteria: schools involved in structured prevention programs with similar objectives

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Preadolescents allocated to the Diario della Salute (DDS) intervention. | Other: Diario della Salute (DDS)<br>* 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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universal prevention, primary prevention, health promotion, wellbeing, smoking, alcohol, diet, physical activity, emotional and social skills