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 (RAISE-PT)
Promoting Early Childhood: Implementation and Evaluation of the RAISE in Portugal
Study Overview
Detailed Description
Child mental health has become one of the most pressing public health concerns worldwide. It is estimated that between 13% and 20% of children and adolescents present some form of mental disorder, such as anxiety or depression, and approximately half of adult mental disorders begin before the age of 18 . These figures underscore the importance of promoting psychological well-being from early childhood and of identifying domains that play a protective role for mental health. Among these, socioemotional development has been described as the foundation of mental health, integrating emotional and social competencies that are fundamental for recognizing and self-regulating emotions, constructing identity, establishing positive interpersonal relationships, supporting learning, and making responsible decisions .
Among the theoretical models seeking to explain the development of these competencies, Malti's framework organizes socioemotional development around three components - the 3 E's: Emotion Regulation, Self-Empathy, and Empathy for Others. Emotion regulation, the first of these components, refers to the human capacity to control the occurrence, intensity, and expression of internal states in order to achieve goals and develop morally appropriate behaviors , involving both adaptive strategies (e.g., cognitive reappraisal) and maladaptive strategies (e.g., rumination, suppression) . Emotion regulation develops across the lifespan, initially supported by processes of hetero- and co-regulation with attachment figures and progressively internalized into self-regulatory skills, particularly between the ages of 3 and 4. Empathy, in turn, constitutes a central indicator of socioemotional development and unfolds across three dimensions - affective, cognitive, and behavioral - whose emergence begins in the first months of life and becomes progressively more complex throughout childhood .
Although primary caregivers play a central role in the development of these competencies , as children gain autonomy and enter preschool education, their relational world expands beyond the family context . From this ecological perspective, educators and teachers emerge as authentic agents with a decisive role in promoting children's socioemotional competencies . At the same time, the socioemotional competencies of these professionals themselves shape classroom climate and children's development . Yet the complexity of the profession and continuous exposure to emotional demands make educators and teachers particularly vulnerable to burnout and exhaustion - the so-called "burnout cascade" with direct implications for their well-being and for the quality of their interactions with children .
Considered jointly, these lines of evidence converge on the need for socioemotional learning programs that adopt an integrated approach - one that fosters children's development while simultaneously supporting the socioemotional competencies and well-being of caregivers and educators, and that addresses protective and risk factors for mental health. It is within this framework that the RAISE program (Research and Practice Partnership: Building Awareness and Increasing Social-Emotional Capacity in the Early Years) emerges, developed at the Centre for Child Development, Mental Health, and Policy (Canada), and grounded in Malti's E's model and in the developmental paradigm of Kindness . The program targets caregivers and education professionals working with children aged 3 to 8 and is organized into three modules - socioemotional development, early relationships (the 3 C's: connection, caring, and coaching), and developmental indicators such as well-being and stress - articulating three core pillars: knowledge, practice, and routine .
In Portugal, the scarcity of structured programs aimed at promoting socioemotional competencies among education professionals makes the cultural adaptation and evaluation of RAISE particularly relevant. The present study therefore aims to evaluate the adaptation, implementation, and effectiveness of the program in the Portuguese context, examining its impact on (i) professionals' knowledge and practices, (ii) professionals' mental health, (iii) children's socioemotional competencies, and (iv) children's mental health, as well as (v) the associations between these variables. It is hypothesized that professionals and children allocated to the intervention group will show significantly greater improvements in these indicators over time compared to those in the control group.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: João Silva, PhD Student
- Phone Number: 35121881700 35121881700
- Email: joao.silva@ispa.pt
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
No Intervention
|
|
|
Active Comparator: Intervention with Raise
Intervention
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Time Frame: Baseline, up to five weeks, up to 13 weeks
|
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)
Time Frame: Baseline, up to five weeks, up to 13 weeks
|
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)
Time Frame: Baseline, up to five weeks, up to 13 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with the training (Speidel et al., 2021, 2023, 2024)
Time Frame: up to five weeks
|
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).
|
up to five weeks
|
|
Perceptions of learning
Time Frame: one weeks, two weeks, three weeks
|
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).
|
one weeks, two weeks, three weeks
|
|
Intent to use strategies
Time Frame: one week, two weeks, three weeks
|
e.g., "To what extent would you use any of the strategies mentioned in the training to promote growth and well-being?").
|
one week, two weeks, three weeks
|
|
Knowledge of training content
Time Frame: Baseline, one week, two weeks, three weeks and up to 13 weeks.
|
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).
|
Baseline, one week, two weeks, three weeks and up to 13 weeks.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Manuela Verissimo, PhD, ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-I-006-03-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.