Clinical Trial

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

Study acronym: Activa-Mente
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-12-02; most recent amendment 2026-06-09.
Status change: Not Yet Recruiting → Active, Not Recruiting 2026-06-09
Trial Details
NCT Number NCT07281482
Lead Sponsor Joan Deus Yela
Collaborators: Cognifit, Universitat Autonoma de Barcelona, Universidad Loyola Andalucia, Universidad de San Buenaventura, Neuronup S.L.
Conditions Child Development, Socioeconomic Factors
Enrollment 500 participants
Start Date 2026-01-26
Primary Completion 2026-12-31 (estimated)
Study Completion 2028-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-10