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 | Not Yet Recruiting

• 1 other identifier: E-I-006-03-26
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Empathy; emotional development; Teacher; behavioral problems

Outcome Measures

Primary Outcomes (3)

• Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)

  The SDQ (Goodman, 1997; Portuguese version: Fleitlich, Loureiro, Fonseca, \& Gaspar, 2005) assesses children's strengths and difficulties across five domains: (1) emotional symptoms, (2) conduct problems, (3) hyperactivity/inattention, (4) peer problems, and (5) prosocial behavior. The scale has 25 items rated on a 3-point scale (0 = not true, 1 = somewhat true, 2 = certainly true). Children's competencies (strengths) are assessed through the prosocial behavior domain, whereas the total difficulties score is derived from the remaining four domains.

  Baseline, up to five weeks, up to 13 weeks

• Depression, Anxiety, and Stress Scale - 21 (DASS-21)

  The DASS-21 (Lovibond \& Lovibond, 1995; Portuguese version: Pais-Ribeiro, Honrado, \& Leal, 2004) is a self-report scale designed to assess the emotional states of depression, anxiety, and stress. It comprises 21 items, each rated on a 4-point scale (0 = did not apply to me at all to 3 = applied to me very much, or most of the time). The scale comprises three subscales: (1) depression (7 items), assessing symptoms such as inertia, dysphoria, lack of interest or involvement, anhedonia, self-deprecation, discouragement, and devaluation of life; (2) anxiety (7 items), assessing autonomic arousal, subjective experiences of anxiety, musculoskeletal effects, and situational anxiety; and (3) stress (7 items), assessing difficulty relaxing, ease of being upset or agitated, nervous arousal, irritability, exaggerated reactions, and impatience.

  Baseline, up to five weeks, up to 13 weeks

• Social-Emotional Responding Task (SERT; Malti, 2017)

  The SERT (Malti, 2017) is an instrument for assessing social-emotional development in children aged 4 to 8 years across four domains: (1) emotion regulation, (2) healthy guilt, (3) self-sympathy, and (4) sympathy for others (Malti, 2017; Malti et al., 2021). The 29-item questionnaire uses a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) and asks caregivers and educators/teachers to rate the child's behavior based on interactions with others and reactions to specific scenarios (e.g., "My child feels bad for other children who are sad").

  Baseline, up to five weeks, up to 13 weeks

Other Outcomes (4)

• Satisfaction with the training (Speidel et al., 2021, 2023, 2024)

  up to five weeks

• Perceptions of learning

  one weeks, two weeks, three weeks

• Intent to use strategies

  one week, two weeks, three weeks

Study Arms (2)

Intervention with Raise

ACTIVE COMPARATOR

Intervention

Behavioral: raise

Control Group

NO INTERVENTION

No Intervention

Interventions

raise BEHAVIORAL

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).

Intervention with Raise

Eligibility Criteria

• Age: 24 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being actively employed as an educator or teacher working with children aged 3 to 8 years;
• being fluent in Portuguese;
• having access to an internet-enabled electronic device (e.g., a smartphone, tablet, or computer) to participate in the online training;
• being available to participate in all phases of the study, including the online training sessions, follow-up assessments, and questionnaire completion;
• providing informed consent to participate in the training, follow-up sessions, and questionnaire completion.

Sponsors & Collaborators

• ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida: lead
• Câmara Municipal Oeiras: collaborator

MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Manuela Verissimo, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Silva, PhD Student

CONTACT

35121881700; joao.silva@ispa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share