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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-65
SponsorISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Intervention with RaiseActive comparator 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, up to five weeks, up to 13 weeks
2

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.

Time frame
Baseline, up to five weeks, up to 13 weeks
3

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").

Time frame
Baseline, up to five weeks, up to 13 weeks

Secondary outcomes

Other outcomes

1

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

After each asynchronous and synchronous session, participants will report their satisfaction with the session on a 10-point scale (1 = very dissatisfied, 4 = to a small extent, 7 = to a moderate extent, 10 = very satisfied).

Time frame
up to five weeks
2

Perceptions of learning

participants will report their perceptions of their own learning on a single item rated on a 10-point scale (1 = not at all to 10 =to a very great extent).

Time frame
one weeks, two weeks, three weeks
3

Intent to use strategies

e.g., "To what extent would you use any of the strategies mentioned in the training to promote growth and well-being?").

Time frame
one week, two weeks, three weeks
4

Knowledge of training content

Participants will report their understanding of core social-emotional concepts. These items were developed by Speidel, Colasante, and Malti to assess knowledge of the core social-emotional concepts targeted in the training (e.g., "I understand what empathy for oneself is and how it develops") as well as knowledge of how to apply them (e.g., "I know how to support children's empathy for themselves"). Items are rated on a 10-point scale (1 = entirely disagree, 4 = somewhat disagree, 7 = somewhat agree, 10 = entirely agree).

Time frame
Baseline, one week, two weeks, three weeks and up to 13 weeks.

Locations

This trial has no locations.

Sponsors and contacts

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