A School-based Prevention Intervention to Promote Wellbeing in Preadolescents (DDS)

January 18, 2014 updated by: Azienda Sanitaria Locale CN2 Alba-Bra

Diario Della Salute (DDS), a School-based Prevention Intervention to Promote Well-being for Grade 7 Students (12-13 Years)

This is a field study aiming to evaluate a school-based prevention intervention, Diario della Salute (DDS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diario della Salute (DDS) is a school-based prevention intervention based on the following theories:

  1. social-cognitive theory (Bandura, 1977; 1986)
  2. theory of multiple intelligences (Gardner, 1987)
  3. emotional intelligence theory (Goleman, 1997)
  4. theory of planned behavior (Ajzen, 1991)
  5. transtheoretical model of change (Prochaska, Diclemente, 1982; 1992).

DDS is composed by:

  1. tools for children and their parents on health and social and emotional well-being issues:

    1. a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control),
    2. a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.);
  2. five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers.

Assignment of schools to study arms (DDS intervention vs. no intervention) will be cluster-randomized. Schools will be matched by number of students and average socioeconomic status. In some study areas schools will not be allocated by chance, but they will be analyzed separately from other schools.

Two anonymous surveys focusing on main outcomes (wellbeing, tobacco smoking, alcohol, physical activity and diet) will be before and after the intervention. Pre and post surveys will be linked through an anonymous code (Galanti, 2006).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2630

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Cuneo
      • Alba, Cuneo, Italy, 12051
        • Azienda Sanitaria Locale CN2 Alba-Bra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • schools providing consensus to study participation

Exclusion Criteria:

  • schools involved in structured prevention programs with similar objectives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Intervention group
Preadolescents allocated to the Diario della Salute (DDS) intervention.
Other: Diario della Salute (DDS)

DDS is composed by

  1. tools for children and their parents on health and social and emotional well-being issues:

    1. a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control),
    2. a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.);
  2. five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-reported Social And Emotional Well-Being
Time Frame: Past 30 Days
Subjective well-being is defined as 'a person's cognitive and affective evaluations of his or her life' (Diener, Lucas, & Oshi, 2002, p. 63).
Past 30 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported Cigarette Use
Time Frame: Past 30 Days
Frequency of cigarette smoking
Past 30 Days
Self-reported Drunkenness Episode(s)
Time Frame: Past 30 Days
Frequency of drunkenness episodes
Past 30 Days
Self-reported Dietary Habits
Time Frame: Past 30 Days
Consumption of beverages and foods such as pop drinks, chips, vegetables, fruits and others
Past 30 Days
Self-reported Frequency of Physical Exercise
Time Frame: Past 30 Days
Frequency of moderate and heavy physical exercise
Past 30 Days
Self-reported Physical and Verbal Aggression
Time Frame: Past 30 Days
Aggression is generally defined as behaviors that are intended to hurt or harm others by damaging their physical and psychological well-being and includes physically and verbally aggressive behaviors such as hitting, pushing, kicking, and threatening, etc (Dodge et al. 2007).
Past 30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Sanitaria Locale CN2 Alba-Bra

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Eastern Piedmont
Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fabrizio Faggiano, MD, University of Eastern Piedmont
  • Study Chair: Antonella Ermacora, MSc, Eclectica Sas di Beccaria Franca, Ermacora Antonella e C.
  • Study Director: Elias Allara, MD, University of Eastern Piedmont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCM2011-CUPJ19E11002100001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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