This Study Aims to Evaluate the Cultural Adaptation, Implementation, and Effectiveness of the RAISE Program Grounded in Malti's 3 E's Model and the Kindness Developmental Paradigm in Portugal

NCT07759531 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-12

No results posted yet for this study

Summary

Child mental health has become a pressing global concern, with 13-20% of children and adolescents presenting mental disorders and about half of adult disorders emerging before age 18. Socioemotional development - encompassing emotion regulation, self-empathy, and empathy for others - is considered a cornerstone of mental health and a key protective factor. Although primary caregivers are central to fostering these competencies, educators also play a decisive role once children enter preschool, while being themselves particularly vulnerable to burnout, with consequences for classroom climate and child outcomes. Integrated programs that simultaneously support children's development and adults' socioemotional competencies are therefore needed, yet remain scarce in Portugal. This study aims to evaluate the cultural adaptation, implementation, and effectiveness of the RAISE program (Research and Practice Partnership: Building Awareness and Increasing Social-Emotional Capacity in the Early Years), developed in Canada and grounded in Malti's 3 E's model and the Kindness developmental paradigm. A Randomized Controlled Trial will be conducted with approximately 100 educators from public and private institutions, randomly allocated to an intervention or waitlist control group. RAISE is delivered online over three weeks, combining asynchronous videos and synchronous group sessions across three modules. Assessments at pre-intervention, post-intervention, and follow-up will use multi-informant measures, including the DASS-21, SDQ, and SERT. Data will be analyzed through mixed ANOVA models following intention-to-treat principles. Findings are expected to inform the feasibility and cultural relevance of integrated, prevention-oriented socioemotional programs and to contribute to early childhood mental health promotion in Portugal.

Conditions

  • Empathy Education

Interventions

BEHAVIORAL

raise

The RAISE training is delivered over three weeks and comprises three modules. Each module includes an asynchronous session (three self-paced 15-minute videos on definitions, developmental examples, and home strategies) followed by a 90-minute synchronous group session focused on practice, mindfulness, discussion, and interactive activities. The modules cover, respectively, the 3 E's of social-emotional development (emotion regulation, self-empathy, and empathy toward others), the 3 C's of early relationships (connection, caring, and coaching), and developmental indicators such as well-being, resilience, and stress, with educators receiving additional content on assessment tools. Follow-up sessions are held one week and two months after completion, and participants retain unlimited online access to all materials (Speidel et al., 2021, 2023, 2024).

Sponsors & Collaborators

  • Câmara Municipal Oeiras

    collaborator UNKNOWN
  • ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

    lead OTHER

Principal Investigators

  • Manuela Verissimo, PhD · ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-12-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759531 on ClinicalTrials.gov