Adolescent BehaviorDDS-2NCT02683811
Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2)
A study testing Diario della Salute (DDS-2) in people with Adolescent Behavior and Health Behavior, run by Azienda Sanitaria Locale CN2 Alba-Bra at 5 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Health Behavior, Mental Health Wellness 1
- What is being tested?
- Diario della Salute (DDS-2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 5 sitesItaly
- Study dates
- Sep 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Azienda Sanitaria Locale CN2 Alba-Bra
Alba, Cuneo, 12051
ASL AL
Casale Monferrato, AL, 15033
ASL CN1
Cuneo, Cuneo, 12100
ASL TO1
Torino, Torino, 10128
Regione Veneto
Venezia, Venezia, 30123
About this study
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
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.
Read the 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.
- Being tested
- Diario della Salute (DDS-2)
- Keywords
- adolescence, prevention, wellbeing, evaluation, effectiveness, school-based program
- Medical subject headings
- Adolescent Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diario della Salute (DDS-2)Behavioural
Also called Percorsi di promozione del benessere tra i pre-adolescenti
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.).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: one month after intervention completion
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one month after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionFeb 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-Bra
- Sponsor type
- University, hospital or other
- Collaborators
- Eclectica Sas di Beccaria Franca, Ermacora Antonella e C., University of Turin, Italy, University of Eastern Piedmont
- Responsible party
- Principal investigator, Laura Marinaro, Azienda Sanitaria Locale CN2 Alba-Bra
- Investigators
- Laura Marinaro, Principal investigator, ASL CN2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683811
- Sponsor's protocol ID
- ASLCN2
- Acronym
- DDS-2
- Status last verified
- Jul 2016
- First submitted
- 18 Dec 2015
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02683811
- Acronym / sponsor ID
- DDS-2 / ASLCN2
- Keywords
- adolescence, prevention, wellbeing, evaluation, effectiveness, school-based program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,600 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-BraUniversity, hospital or other
- Collaborators
- Eclectica Sas di Beccaria Franca, Ermacora Antonella e C., University of Turin, Italy, University of Eastern Piedmont
- Study start
- Sep 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Diario della Salute (DDS-2)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. |
| 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. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diario della Salute (DDS-2)Also: Percorsi di promozione del benessere tra i pre-adolescentiThe 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.). | Behavioural | Intervention group |
Primary outcome
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.
11 secondary outcomes
Verbal and physical aggression (Verbal and Physical Aggression Scale)
Time frame: one month after intervention completion
Prosocial behaviours (Prosocial Behaviours Scale)
Time frame: one month after intervention completion
School success (Health Behavior Questionnaire)
Time frame: one month after intervention completion
Cigarette smoking (HBSC Questionnaire)
Time frame: one month after intervention completion
Frequency of cigarette smoking (HBSC Questionnaire)
Time frame: one month after intervention completion
Alcohol use (HBSC Questionnaire)
Time frame: one month after intervention completion
Drunkenness (HBSC Questionnaire)
Time frame: one month after intervention completion
Eating habits (HBSC Questionnaire)
Time frame: one month after intervention completion
Eating style (HBSC Questionnaire)
Time frame: one month after intervention completion
Physical activity (HBSC Questionnaire)
Time frame: one month after intervention completion
Physical inactivity (HBSC Questionnaire)
Time frame: one month after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- project web siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Marinaro principal investigator
ASL CN2
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diario della Salute (DDS-2) in people with Adolescent Behavior and Health Behavior, run by Azienda Sanitaria Locale CN2 Alba-Bra at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological well-being (Brief Psychological Wellbeing Inventory) (time frame: one month after intervention completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.