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

NCT07281482 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-12-17

No results posted yet for this study

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

Interventions

OTHER

Cognitive and emotional stimulation

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

OTHER

Random activities

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

BEHAVIORAL

Training for parents and teachers

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.

Sponsors & Collaborators

  • Cognifit

    collaborator UNKNOWN
  • Universitat Autonoma de Barcelona

    collaborator OTHER
  • Universidad Loyola Andalucia

    collaborator OTHER
  • Universidad de San Buenaventura

    collaborator OTHER
  • Neuronup S.L.

    collaborator UNKNOWN
  • Joan Deus Yela

    lead OTHER

Principal Investigators

  • Joan Deus-Yela, PhD · Universitat Autonoma de Barcelona

  • Joaquín Ibáñez-Alfonso, PhD · Universidad Loyola Andalucia

  • José Barroso-Tristan, PhD · University of Seville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
9 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-26
Primary Completion
2026-12-31
Completion
2028-01-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281482 on ClinicalTrials.gov