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Prevention of Alcohol Consumption in Childhood in a Multicomponent Community Intervention

Prevention of Alcohol Use in Childhood within a Community-Based Multicomponent Intervention: An Implementation Research Approach

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-24xy2p3
Enrollment
Unknown
Registered
2025-11-11
Start date
2025-08-04
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Development

Interventions

This is a nonrandomized controlled study conducted in two municipalities in the state of São Paulo, with allocation by municipality: Salesópolis as the intervention group and Biritiba-Mirim as the con
a Consolidation Phase of approximately ten weeks with monthly on-site supervision and remote support between visits to deepen program use and tailor it to context
and an Expansion Phase of approximately seven weeks with a return to biweekly on-site supervision to consolidate teacher autonomy and consistent delivery, plus continuous remote suppor

Sponsors

Departamento de Psiquiatria
Lead Sponsor
Departamento de Psiquiatria
Collaborator

Eligibility

Age
5 Years to 17 Years

Inclusion criteria

Inclusion criteria: Eligible participants include children enrolled in grades 1–5 of elementary school who attend participating municipal schools in Salesópolis or Biritiba-Mirim; participation requires a signed informed consent form from parents or legal guardians and child assent; homeroom teachers of participating classes will also take part because they are involved in training and classroom observations

Exclusion criteria

Exclusion criteria: Participants will be excluded if a signed informed consent form from the legal guardians and the child’s assent are not provided

Design outcomes

Primary

MeasureTime frame
We expect to reduce disruptive behavior during instructional time. Assessments will occur at three time points: baseline, immediate post-intervention, and 6-month follow-up. Primary measure: the Teacher Observation of Classroom Adaptation—Revised, the Brazilian-adapted version, which captures aggression, disruptive behavior, on-task engagement, socialization, and self-control.Complementary measure: standardized observation of school environment quality using the Instrument for Observing the Quality of Elementary Education I, yielding age-appropriate behavioral and emotional indicators

Secondary

MeasureTime frame
We expect increased on-task engagement, more frequent prosocial and concentration behaviors, and reduced emotional symptoms, conduct problems, and hyperactivity/inattention. We also anticipate improvements in classroom climate and overall engagement. All outcomes will be measured with validated, age-appropriate instruments at baseline, immediate post-intervention, and 6-month follow-up

Countries

Brazil

Contacts

Public ContactSheila Caetano

Universidade Federal de São Paulo

sheila.caetano@unifesp.br+55(11)98782-4398

Outcome results

None listed

Source: REBEC (via WHO ICTRP)