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

Azienda Sanitaria Locale CN2 Alba-Bra

Status: Completed

Conditions: Major Risk Factors for Noncommunicable Diseases

Treatments: Other: Diario della Salute (DDS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01720199

CCM2011-CUPJ19E11002100001

Details and patient eligibility

About

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

Full 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).

Enrollment: 2,630 patients

Sex: All

Ages: 11 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• schools providing consensus to study participation

Exclusion criteria

• schools involved in structured prevention programs with similar objectives

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,630 participants in 2 patient groups

Intervention group

Experimental group

Description:

Preadolescents allocated to the Diario della Salute (DDS) intervention.

Treatment:

Other: Diario della Salute (DDS)

Control group

No Intervention group