Randomised Controlled Trial of a Cognitive, Emotional and Social Stimulation Programme for Socioeconomically Disadvantaged Children.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- Pre- and post-intervention scores on the general cognitive assessment battery of Cognifit
Study Overview
Brief Summary
Latin America and the Caribbean exhibit high rates of poverty and social exclusion, where a significant portion of the population faces challenges in meeting basic needs. This socioeconomic vulnerability exacerbates environmental violence and its associated consequences. Recognizing that contexts of poverty and social exclusion can adversely impact children's cognitive and emotional development, this research protocol aims to address these challenges. It proposes a cognitive and emotional stimulation program, complemented by an intervention targeting teachers and caregivers, grounded in neuroeducational principles. The overarching goal is to enhance children's cognitive and academic performance, thereby improving their long-term quality of life. Methods: A randomised controlled trial will be conducted to evaluate the efficacy of the intervention in an experimental group compared to a control group. A sample of more than 500 children from primary schools in disadvantaged contexts in Colombia A digital stimulation programme, designed and supervised by neuropsychologists, will be implemented within the classrooms and will be complemented with educational sessions in neuroeducation for teachers and caregivers, with weekly activities for 3 months. Three evaluations will be carried out: 1) pre-intervention, 2) post-intervention and 3) follow-up. During follow-up, the control group will receive the stimulation programme. Conclusions: The researchers anticipate a positive impact on the cognitive, emotional and academic performance of these children, providing evidence and support for the long-term creation of a tested and validated cognitive and emotional stimulation programme that could be integrated into the academic curriculum of educational centres in disadvantaged contexts.
Detailed Description
There is evidence of a large gap in the cognitive development of children and adolescents in violent contexts and situations of socio-economic vulnerability. There are multiple reasons that affect the cognitive and emotional development of these children, who are at a disadvantage with respect to children of the same age who are not in the same situation or who enjoy better contextual situations. Poor nutrition, the type of stimulation provided by the environment, stressful situations and the constant subjection of the brain to states of alertness encourage the deficiencies found in their integral development. This neuropsychological stimulation programme specifically designed for children at risk of social exclusion aims to be an effective tool in strengthening some of the cognitive abilities with the greatest evidence of impairment, in this case, language (e.g., vocabulary, comprehension and expression), attention (especially the ability to sustain it voluntarily for prolonged periods of time: concentration), and executive functions (set of skills that allow us to voluntarily regulate our behaviour thanks to the inhibition of responses, planning, reasoning and flexible decision making adjusted to the demands of the environment).
In response to the results and observations of the studies carried out within the framework of project 0C138/2020 'MEJORA GUATE', this research proposes intervention objectives for the needs of the participating population, based on a more holistic strategy that integrates the child and their immediate environment. Considering that caregivers and teachers mediate cognitive, emotional, and social development, this project seeks to improve the impact on the different areas of the child's performance. To achieve the planned objectives, work will be carried out through three main axes of application: the neuropsychological stimulation axis, the neurodevelopment training axis, and the dissemination axis, which will in turn be divided into two phases.
The Neuropsychological Stimulation Axis: aims to improve and enhance the development of the cognitive and emotional skills of children from disadvantaged areas of Colombia through direct intervention with them through group activities carried out in their usual educational contexts. To this end, innovative neuropsychological tools from the clinical care of children with neurodevelopmental disorders will be applied to the cognitive and emotional stimulation of these children at risk of social exclusion.
The Training Axis: will build the knowledge base on neurodevelopment and brain function in learning, with the aim of promoting best practice in the implementation of teaching staff, as well as parenting practices and home support by carers. The training will be delivered in a dual format, face-to-face and online, following pedagogical processes with established didactic objectives, evaluation criteria and monitoring of the training received.
The Dissemination Axis: aims to disseminate the advances and results of the research, as well as the pedagogical content of the training, which will generate a greater social reach by promoting complementary channels through which the content on learning and its brain functioning can be shared with different social actors in a didactic and pedagogical way. In terms of resources, it is proposed to create a handbook of good practices to serve as a model for other educational communities, a website with didactic resources and asynchronous training processes, as well as fluid channels for sharing knowledge through social networks commonly used by these groups, such as WhatsApp or Instagram.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 9 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Child's age (must be enrolled between the fourth and fifth grades of basic primary school and sixth and seventh grades of basic secondary school ).
- •Belonging to a school in a disadvantaged area of the city of application.
- •Informed consent signed by the participant's legal guardian.
- •Verbal consent of the participants.
- •Possess basic reading skills in Spanish and sufficient motor skills to handle tablets or use a computer mouse.
Exclusion Criteria
- •Not having basic reading skills in Spanish.
- •Being enrolled in a school year other than fourth and fifth grade of elementary school or sixth and seventh grade of secondary school.
- •Not belonging to a disadvantaged area of the city of Cali.
- •Having a physical disability that prevents the use of tablets and mice.
- •Not having signed the participation consent form by their parents.
Arms & Interventions
Cognitive stimulation group
The experimental group receives cognitive stimulation through platforms such as Cognifit and Neuronup.
Intervention: Cognitive and emotional stimulation (Other)
Cognitive stimulation group
The experimental group receives cognitive stimulation through platforms such as Cognifit and Neuronup.
Intervention: Training for parents and teachers (Behavioral)
placebo group
The control group receives random activities that do not affect their cognitive development.
Intervention: Random activities (Other)
Outcomes
Primary Outcomes
Pre- and post-intervention scores on the general cognitive assessment battery of Cognifit
Time Frame: 12 months
The Cognitive Assessment Battery (CAB) studies brain function and performs a comprehensive cognitive screening. It accurately assesses a wide range of skills and detects cognitive well-being (high-medium-low). It identifies weaknesses and strengths in the areas of memory, attention-concentration, executive functions, planning, and coordination. All cognitive scores are classified from 0 to 100. In the case of individual cognitive abilities, this score corresponds to a percentile division of the data into equal groups. In the case of cognitive areas and the overall score, this result corresponds to the average of the scores for individual abilities. In all cases, the score is interpreted as follows: 0-25: cognitive weaknesses. 26-50: expected average range, but below average. 51-75: adequate, above average but within the expected range. 76-100: high, well above what is expected for age and gender.
Pre- and post-intervention scores on the Emotional Intelligence Assessment Battery
Time Frame: 12 months
The evaluation of emotional skills or emotional intelligence will be carried out by applying the adaptation and standardization of the BarOn Emotional Intelligence Inventory ICE: NA, in children and adolescents. It is an instrument that measures the skills and competencies characteristic of emotional intelligence (ability to understand oneself and others, ability to relate to peers and family members and ability to adapt to the demands of the environment), integrates interpersonal, intrapersonal, stress management, adaptability and mood scales in general. It provides information about the emotional and social intelligence of the person being evaluated. Interpretation of scores: ≥130: Atypically high emotional and social skills, excellent development. 120-129: Very high, very well developed. 110-119: High, well developed. 90-109: Adequate, average level. 80-89: Low, poorly developed, require improvement. 70-79: Very low, need considerable improvement. ≤69: Atypical and deficient.
Secondary Outcomes
- Pre- and post-intervention scores on the Nonverbal intelligence. TONI 4(12 months)
Investigators
Joan Deus Yela
Doctor en Psicología
Universitat Autonoma de Barcelona
