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Completed

NCT Number: NCT02683811

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

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.

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Key information

Age range

11 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASL AL, Casale Monferrato, AL, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.).

Other names: Percorsi di promozione del benessere tra i pre-adolescenti

Primary outcomes

  1. Psychological well-being (Brief Psychological Wellbeing Inventory)

    Time frame: one month after intervention completion

    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

  2. Psychosomatic disorders (Health Behaviors in School-aged Children - Symptom checklist)

    Time frame: one month after intervention completion

    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

  3. Health status (Health Behaviors in School-aged Children Questionnaire)

    Time frame: one month after intervention completion

    1 item from the Italian version of HBSC (Health Behaviors in School-aged Children) Questionnaire assessing the general perceived health status.

Secondary outcomes

  1. Verbal and physical aggression (Verbal and Physical Aggression Scale)

    Time frame: one month after intervention completion

    20 items from Verbal and Physical Aggression Scale (Caprara & Pastorelli, 1988) assessing the frequency of aggressive behaviors

  2. Prosocial behaviours (Prosocial Behaviours Scale)

    Time frame: one month after intervention completion

    15 item from Prosocial Behaviours Scale (Caprara & Pastorelli, 1988) assessing the frequency of prosocial behaviours

  3. School success (Health Behavior Questionnaire)

    Time frame: one month after intervention completion

    1 item from the Health Behavior Questionnaire (Jessor et al., 1992 - Italian version by Bonino et al., 2003) assessing the school performance

  4. Cigarette smoking (HBSC Questionnaire)

    Time frame: one month after intervention completion

    3 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing cigarette smoking behavior

  5. Frequency of cigarette smoking (HBSC Questionnaire)

    Time frame: one month after intervention completion

    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

  6. Alcohol use (HBSC Questionnaire)

    Time frame: one month after intervention completion

    3 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the use of alcohol

  7. Drunkenness (HBSC Questionnaire)

    Time frame: one month after intervention completion

    3 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of drunkenness

  8. Eating habits (HBSC Questionnaire)

    Time frame: one month after intervention completion

    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

  9. Eating style (HBSC Questionnaire)

    Time frame: one month after intervention completion

    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

  10. Physical activity (HBSC Questionnaire)

    Time frame: one month after intervention completion

    4 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of physical activity per week

  11. Physical inactivity (HBSC Questionnaire)

    Time frame: one month after intervention completion

    6 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of sedentary behaviours per day

Other outcomes

  1. Emotional skills (Self- Efficacy Scale)

    Time frame: one month after intervention completion

    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

  2. Satisfaction with school (School Situation Questionnaire)

    Time frame: one month after intervention completion

    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

  3. Social skills (Self- Efficacy Scale)

    Time frame: one month after intervention completion

    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

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale CN2 Alba-Bra

Other

Collaborators

  • Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
  • University of Eastern Piedmont
  • University of Turin, Italy

Registry information

Official study 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

Acronym: DDS-2

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2016
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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