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

NCT02683811 | Completed

• 1 other identifier: ASLCN2
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Adolescent Behavior; Health Behavior; Mental Health Wellness 1

Keywords

adolescence; prevention; wellbeing; evaluation; effectiveness; school-based program

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Verbal and physical aggression (Verbal and Physical Aggression Scale)

  one month after intervention completion

• Prosocial behaviours (Prosocial Behaviours Scale)

  one month after intervention completion

• School success (Health Behavior Questionnaire)

  one month after intervention completion

• Cigarette smoking (HBSC Questionnaire)

  one month after intervention completion

• Frequency of cigarette smoking (HBSC Questionnaire)

  one month after intervention completion

Other Outcomes (3)

• Emotional skills (Self- Efficacy Scale)

  one month after intervention completion

• Satisfaction with school (School Situation Questionnaire)

  one month after intervention completion

• Social skills (Self- Efficacy Scale)

  one month after intervention completion

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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.

Interventions

Diario della Salute (DDS-2) BEHAVIORAL

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.).

Also known as: Percorsi di promozione del benessere tra i pre-adolescenti

Intervention group

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Sanitaria Locale CN2 Alba-Bra: lead
• Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.: collaborator
• University of Turin, Italy: collaborator
• University of Eastern Piedmont: collaborator

Study Sites (5)

ASL AL

Casale Monferrato, AL, 15033, Italy

Location

Azienda Sanitaria Locale CN2 Alba-Bra

Alba, Cuneo, 12051, Italy

Location

ASL CN1

Cuneo, Cuneo, 12100, Italy

Location

ASL TO1

Torino, Torino, 10128, Italy

Location

Regione Veneto

Venezia, Venezia, 30123, Italy

Location

Related Links

• project web site

MeSH Terms

Conditions

Adolescent Behavior; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Laura Marinaro

  ASL CN2

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Laura Marinaro

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: February 17, 2016
• Study Start: September 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

IT (5)