Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2)

Study Overview
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Brief Summary
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This study evaluates the short- and long-term effects on psychological wellbeing and health-related behaviours of the updated version of a universal school-based program called Diario della Salute (DDS-2) in Italian students aged 11-13 years.

Detailed Description
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The updated version of Diario della Salute (DDS-2) is a universal school-based intervention aimed at promoting psychological and emotional well-being and preventing unhealthy and risky behaviours (cigarettes smoking, alcohol abuse, unhealthy eating habits, physical inactivity) in preadolescence. The program is composed by 5 highly standardized interactive units delivered by previously trained teachers during school hours on emotional and social issues related to developmental tasks in adolescence. The kit includes: 1) a teacher's manual, 2) a booklet for each participating student, 3) a booklet for parents of each participating student. The objective is to promote and reinforce adolescents' emotional and social skills as factors contributing to adolescent well-being and health. A randomised controlled trial with two parallel groups is performed, with 1:1 allocation ratio, in two different Regions of Italy (Piedmont and Veneto). Schools are randomly assigned to one of the two groups (DDS-2 intervention vs. no intervention) and are used as the unit of allocation. Individual participants (i.e. students) are the unit of analysis. Schools are matched by number of students and average socioeconomic status. Eligible schools are identified from the list of all schools having students from 11 to 13 located in study sites. A number of eligible schools accounting for the requested number of students in the target grades is invited to participate in the study. If a school does not respond to the invitation or declines to participate, the school recruitment process is repeated, and another eligible school is invited to participate. The process continues until achievement of the sample size. No incentive is offered to students, families and schools for participating in the study. A paper-and-pencil self-report anonymous questionnaire developed by the research group is used to determine whether the interventions have changed the outcomes. The questionnaire will be administered in classes by the researchers at baseline, at the end of the intervention and one-year after the end of the intervention (at equal intervals both in the intervention and in the control group). The questionnaire consists of the following sections: 1) demographics, 2) emotional and social skills, 3) psychological wellbeing, 4) school experience, 5) unhealthy and risky behaviours, 6) prosocial and aggressive behaviours. Questionnaires are linked through an anonymous self-generated code.

Official Title
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A Randomised Controlled Study for Evaluating the Effectiveness of the Updated Version of Diario Della Salute, a School-based Program for Prevention of Unhealthy and Risky Behaviours and Promotion of Well-being in Italian Pre-adolescents

Conditions
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Adolescent Behavior, Health Behavior, Mental Health Wellness 1

Intervention / Treatment
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* Behavioral: Diario della Salute (DDS-2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: public/government schools, at least two classes attended by students aged 11-13, not participating in other school-based programs with similar objectives targeted to the classes of interest, providing consensus to study participation. In participating schools, all classes of students aged between 11 and 13 years are eligible to be enrolled in the study. Exclusion Criteria: private schools, less than two classes attended by students aged 11-13, involved in other school-based programs with similar objectives targeted to the classes of interest. In participating schools, students whose parents opt out from the study are excluded.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 13 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Diario della Salute (DDS-2), a school-based program aimed to promote psychological well-being and to prevent cigarette smoking, alcohol abuse, unhealthy eating habits, physical inactivity in preadolescents aged 11-13 years. The program is composed by 5 highly standardised interactive units led by previously trained teachers during school hours (15 hours total). Units focus on emotional and social issues related to adolescent developmental tasks. The goal is to promote the adolescent emotional and social skills. | Behavioral: Diario della Salute (DDS-2)<br>* The updated version of Diario della Salute program (DDS-2) includes: 1) teachers' manual, 2) a booklet for teens telling the story of four same-age students (e.g. experimenting with risky behaviours, conflicting feelings and thoughts, need for independence and control, etc.), 3) a booklet for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflicts, parental control and supervision, family communication, etc.).<br>* Other names: Percorsi di promozione del benessere tra i pre-adolescenti;|
| No Intervention: Control group<br>No intervention aimed at preventing cigarette smoking, alcohol abuse, unhealthy eating habits, physical inactivity and promoting emotional and social well-being is administered at school by teachers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological well-being (Brief Psychological Wellbeing Inventory) | Four scales (3 items per scale) from Brief Psychological Wellbeing Inventory (PWB, Ryff & Keyes, 1995 - Italian version by Cicognani, Zani, 1999) assessing different areas of perceived wellbeing such as autonomy, environmental mastery, positive relations with others, self-acceptance | one month after intervention completion | 
| Psychosomatic disorders (Health Behaviors in School-aged Children - Symptom checklist) | 8 items from the Italian version of HBSC (Health Behaviors in School-aged Children - Symptom checklist (Haugland et al., 2001; Raves-Sieberer et al., 2009) assessing the frequency of perceived psychological and somatic disorders | one month after intervention completion | 
| Health status (Health Behaviors in School-aged Children Questionnaire) | 1 item from the Italian version of HBSC (Health Behaviors in School-aged Children) Questionnaire assessing the general perceived health status. | one month after intervention completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal and physical aggression (Verbal and Physical Aggression Scale) | 20 items from Verbal and Physical Aggression Scale (Caprara & Pastorelli, 1988) assessing the frequency of aggressive behaviors | one month after intervention completion | 
| Prosocial behaviours (Prosocial Behaviours Scale) | 15 item from Prosocial Behaviours Scale (Caprara & Pastorelli, 1988) assessing the frequency of prosocial behaviours | one month after intervention completion | 
| School success (Health Behavior Questionnaire) | 1 item from the Health Behavior Questionnaire (Jessor et al., 1992 - Italian version by Bonino et al., 2003) assessing the school performance | one month after intervention completion | 
| Cigarette smoking (HBSC Questionnaire) | 3 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing cigarette smoking behavior | one month after intervention completion | 
| Frequency of cigarette smoking (HBSC Questionnaire) | 1 item from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the number of smoked cigarettes in the last month | one month after intervention completion | 
| Alcohol use (HBSC Questionnaire) | 3 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the use of alcohol | one month after intervention completion | 
| Drunkenness (HBSC Questionnaire) | 3 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of drunkenness | one month after intervention completion | 
| Eating habits (HBSC Questionnaire) | 16 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of use of healthy and unhealthy food | one month after intervention completion | 
| Eating style (HBSC Questionnaire) | 2 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of healthy and unhealthy eating habits per week | one month after intervention completion | 
| Physical activity (HBSC Questionnaire) | 4 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of physical activity per week | one month after intervention completion | 
| Physical inactivity (HBSC Questionnaire) | 6 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of sedentary behaviours per day | one month after intervention completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescence, prevention, wellbeing, evaluation, effectiveness, school-based program