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

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness 1; Health Behavior; Adolescent Behavior
• Intervention / Treatment: Behavioral: Diario della Salute (DDS-2)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 3600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Cuneo, Italy, 12100
    • ASL CN1
  • Torino, Italy, 10128
    • ASL TO1
  • Venezia, Italy, 30123
    • Regione Veneto
  • AL
    • Casale Monferrato, AL, Italy, 15033
      • ASL AL
  • Cuneo
    • Alba, Cuneo, Italy, 12051
      • Azienda Sanitaria Locale CN2 Alba-Bra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. public/government schools,
2. at least two classes attended by students aged 11-13,
3. not participating in other school-based programs with similar objectives targeted to the classes of interest,
4. 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:

1. private schools,
2. less than two classes attended by students aged 11-13,
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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); 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.).; Other Names: Percorsi di promozione del benessere tra i pre-adolescenti
No Intervention: Control group; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional skills (Self- Efficacy Scale)	27 items from the Italian version of Self- Efficacy Scale (Bandura, 1997 - Italian version by Caprara et al., 2001) assessing the perceived individual emotional skills	one month after intervention completion
Satisfaction with school (School Situation Questionnaire)	4 scales (5 items per scale) from the School Situation Questionnaire (Santinello & Bertarelli, 2002) assessing the quality of relationship with schoolmates and teachers, self-esteem at school, attitude towards learning	one month after intervention completion
Social skills (Self- Efficacy Scale)	13 27 items from the Italian version of Self- Efficacy Scale (Bandura, 1997 - Italian version by Caprara et al., 2001) assessing the perceived individual social skills	one month after intervention completion

Collaborators and Investigators

• Sponsor: Azienda Sanitaria Locale CN2 Alba-Bra
• Collaborators: University of Turin, Italy; University of Eastern Piedmont; Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
• Investigators: Principal Investigator: Laura Marinaro, ASL CN2

Publications and helpful links

Helpful Links

• project web site

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: effectiveness; prevention; evaluation; adolescence; wellbeing; school-based program
• Other Study ID Numbers: ASLCN2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Study Data/Documents

1. Study Protocol
   Information comments: Study protocol (Italian version) can be requested by contacting the project manager (lmarinaro@aslcn2.it)
2. program materials and tools
   Information comments: The Italian version of program materials and tools (teachers' manual, students' booklet and parents' booklet) can be freely accessed and downloaded from project web site.