Study Protocol: Cognitive, Emotional and Social Stimulation Programme for Low-SES Children.

NCT07281482 | Not Yet Recruiting DMC

• 1 other identifier: UAB-ACTIVA-MENTE-2025-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Child Development; Socioeconomic Factors

Keywords

cognitive stimulation; vulnerability; child development; Neuropsychology; Emotional stimulation; randomized controlled trials

Outcome Measures

Primary Outcomes (2)

• Pre- and post-intervention scores on the general cognitive assessment battery of Cognifit

  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.

  12 months

• Pre- and post-intervention scores on the Emotional Intelligence Assessment Battery

  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.

  12 months

Secondary Outcomes (1)

• Pre- and post-intervention scores on the Nonverbal intelligence. TONI 4

  12 months

Study Arms (2)

Cognitive stimulation group

EXPERIMENTAL

The experimental group receives cognitive stimulation through platforms such as Cognifit and Neuronup.

Other: Cognitive and emotional stimulation; Behavioral: Training for parents and teachers

placebo group

PLACEBO COMPARATOR

The control group receives random activities that do not affect their cognitive development.

Other: Random activities

Interventions

Random activities OTHER

Random activities will be carried out for the control group that will not include the improvement of cognitive functions.

placebo group

Cognitive and emotional stimulation OTHER

Continuous cognitive and emotional stimulation is provided in the school setting.

Cognitive stimulation group

Training for parents and teachers BEHAVIORAL

Training in neuroeducation and learning strategies focused on brain function will be provided for teachers and parents, with the level of depth appropriate for each group.

Cognitive stimulation group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joan Deus Yela: lead
• Universitat Autonoma de Barcelona: collaborator
• Cognifit: collaborator
• Universidad Loyola Andalucia: collaborator
• Universidad de San Buenaventura: collaborator
• Neuronup S.L.: collaborator

Study Sites (2)

Institución Educativa la Buitrera

Cali, Valle del Cauca Department, 760000, Colombia

Location

Colegio Fray Luis Amigo

Cali, Valle del Cauca Department, 760020, Colombia

Location

Related Publications (6)

• Garcia-Navarro C, Company-Cordoba R, Sianes A, Ibanez-Alfonso JA. Cognitive Intervention Programs in Minors Belonging to Disadvantaged Contexts in Spain: A Systematic Review. Children (Basel). 2022 Aug 28;9(9):1306. doi: 10.3390/children9091306.

  PMID: 36138615 BACKGROUND

• Ibáñez-Alfonso JA, Company-Córdoba R,, García de la Cadena C. Innovative tools for the assessment of cognitive development in contexts of socioeconomic vulnerability. Practical guide for children and adolescents in Guatemala. 2020

  BACKGROUND

• Rodriguez-Prieto P, Simpson IC, Gomez-Baya D, Garcia de la Cadena C, Ruiz-Aranda D, Ibanez-Alfonso JA. Neuropsychological Stimulation Program for Children from Low Socioeconomic Backgrounds: Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2024 Mar 6;12(5):596. doi: 10.3390/healthcare12050596.

  PMID: 38470707 BACKGROUND

• Rodriguez-Prieto P, Giral-Oliveros NA, Simpson IC, Ibanez-Alfonso JA. Cognitive stimulation in socioeconomically disadvantaged children with neurodevelopmental disorders: a case series. Front Psychol. 2024 Jul 9;15:1365697. doi: 10.3389/fpsyg.2024.1365697. eCollection 2024.

  PMID: 39045438 BACKGROUND

• Ibanez-Alfonso JA, Company-Cordoba R, Garcia de la Cadena C, Sianes A, Simpson IC. How Living in Vulnerable Conditions Undermines Cognitive Development: Evidence from the Pediatric Population of Guatemala. Children (Basel). 2021 Jan 29;8(2):90. doi: 10.3390/children8020090.

  PMID: 33572817 BACKGROUND

• Company-Cordoba R, Gomez-Baya D, Lopez-Gavino F, Ibanez-Alfonso JA. Mental Health, Quality of Life and Violence Exposure in Low-Socioeconomic Status Children and Adolescents of Guatemala. Int J Environ Res Public Health. 2020 Oct 19;17(20):7620. doi: 10.3390/ijerph17207620.

  PMID: 33086701 BACKGROUND

Study Officials

• Joan Deus-Yela, PhD

  Universitat Autonoma de Barcelona

  STUDY DIRECTOR

• Joaquín Ibáñez-Alfonso, PhD

  Universidad Loyola Andalucia

  PRINCIPAL INVESTIGATOR

• José Barroso-Tristan, PhD

  University of Seville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Bedoya-Restrepo, PhD candidate

CONTACT

+34629519761; vanessa.bedoya@autonoma.cat

Joaquín Ibáñez-Alfonso, PhD

CONTACT

+34676090960; jaibanez@uloyola.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor en Psicología

Model Details: This research will employ a cluster randomised controlled trial design, as the class or school group receiving the intervention will be randomly selected and compared with another group engaged in regular educational activities conducted concurrently. The study will be conducted in real contexts, and schools will be invited to participate through an open call. Participants will be randomly assigned per class group to the experimental group, while the remaining participants will constitute the control group. The intervention programme will be offered to all participating children in the class that is part of the experimental group. The research team will ensure that both groups are homogeneous in their demographic characteristics (age, gender, socioeconomic status).

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 15, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)