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

Health Behavior Clinical Trial

— DDS-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683811
• Other study ID #: ASLCN2
• Status: Completed
• Phase: N/A
• First received: December 18, 2015
• Last updated: July 27, 2016
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Azienda Sanitaria Locale CN2 Alba-Bra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3600
• Est. completion date: July 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 13 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescent Behavior
• Health Behavior
• Mental Health Wellness 1

Intervention

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.).

Locations

Country	Name	City	State
Italy	Azienda Sanitaria Locale CN2 Alba-Bra	Alba	Cuneo
Italy	ASL AL	Casale Monferrato	AL
Italy	ASL CN1	Cuneo
Italy	ASL TO1	Torino
Italy	Regione Veneto	Venezia

Sponsors (4)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale CN2 Alba-Bra	Eclectica Sas di Beccaria Franca, Ermacora Antonella e C., University of Eastern Piedmont, University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   project web site