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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683811
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : July 28, 2016
Sponsor:
Collaborators:
Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
University of Turin, Italy
University of Eastern Piedmont
Information provided by (Responsible Party):
Laura Marinaro, Azienda Sanitaria Locale CN2 Alba-Bra

Tracking Information
First Submitted Date  ICMJE December 18, 2015
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date July 28, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
  • 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
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • Psychological well-being (Brief Psychological Wellbeing Inventory) [ Time Frame: one month after intervention completition ]
    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
  • Psychosomatic disorders (Health Behaviors in School-aged Children - Symptom checklist) [ Time Frame: one month after intervention completition ]
    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
  • Health status (Health Behaviors in School-aged Children Questionnaire) [ Time Frame: one month after intervention completition ]
    1 item from the Italian version of HBSC (Health Behaviors in School-aged Children) Questionnaire assessing the general perceived health status.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • Verbal and physical aggression (Verbal and Physical Aggression Scale) [ Time Frame: one month after intervention completition ]
    20 items from Verbal and Physical Aggression Scale (Caprara & Pastorelli, 1988) assessing the frequency of aggressive behaviors
  • Prosocial behaviours (Prosocial Behaviours Scale) [ Time Frame: one month after intervention completition ]
    15 item from Prosocial Behaviours Scale (Caprara & Pastorelli, 1988) assessing the frequency of prosocial behaviours
  • School success (Health Behavior Questionnaire) [ Time Frame: one month after intervention completition ]
    1 item from the Health Behavior Questionnaire (Jessor et al., 1992 - Italian version by Bonino et al., 2003) assessing the school performance
  • Cigarette smoking (HBSC Questionnaire) [ Time Frame: one month after intervention completition ]
    3 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing cigarette smoking behavior
  • Frequency of cigarette smoking (HBSC Questionnaire) [ Time Frame: one month after intervention completition ]
    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
  • Alcohol use (HBSC Questionnaire) [ Time Frame: one month after intervention completition ]
    3 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the use of alcohol
  • Drunkenness (HBSC Questionnaire) [ Time Frame: one month after intervention completition ]
    3 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of drunkenness
  • Eating habits (HBSC Questionnaire) [ Time Frame: one month after intervention completition ]
    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
  • Eating style (HBSC Questionnaire) [ Time Frame: one month after intervention completition ]
    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
  • Physical activity (HBSC Questionnaire) [ Time Frame: one month after intervention completition ]
    4 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of physical activity per week
  • Physical inactivity (HBSC Questionnaire) [ Time Frame: one month after intervention completition ]
    6 items from the Italian version of HBSC (Health Behaviours in School-aged Children) Questionnaire assessing the frequency of sedentary behaviours per day
Current Other Pre-specified Outcome Measures
 (submitted: February 17, 2016)
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: February 12, 2016)
  • Emotional skills (Self- Efficacy Scale) [ Time Frame: one month after intervention completition ]
    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
  • Satisfaction with school (School Situation Questionnaire) [ Time Frame: one month after intervention completition ]
    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
  • Social skills (Self- Efficacy Scale) [ Time Frame: one month after intervention completition ]
    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
 
Descriptive Information
Brief Title  ICMJE Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2)
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Adolescent Behavior
  • Health Behavior
  • Mental Health Wellness 1
Intervention  ICMJE 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 Name: Percorsi di promozione del benessere tra i pre-adolescenti
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Diario della Salute (DDS-2)
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2016)
3600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683811
Other Study ID Numbers  ICMJE ASLCN2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Laura Marinaro, Azienda Sanitaria Locale CN2 Alba-Bra
Study Sponsor  ICMJE Azienda Sanitaria Locale CN2 Alba-Bra
Collaborators  ICMJE
  • Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
  • University of Turin, Italy
  • University of Eastern Piedmont
Investigators  ICMJE
Principal Investigator: Laura Marinaro ASL CN2
PRS Account Azienda Sanitaria Locale CN2 Alba-Bra
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP