NCT07097090

Brief Summary

The goal of this quasi-experimental study is to investigate whether enhancing emotion recognition abilities can improve social behavior in primary school children. The study focused on children aged approximately 6 to 9 years (both sexes), attending elementary school, without neurological or psychiatric diagnoses. The main questions it aims to answer are: Is there an inverse relationship between children's ability to recognize nonverbal emotional cues and antisocial behavior, as assessed by teachers? Does nonverbal intelligence (measured through Raven's Colored Progressive Matrices) significantly predict emotion recognition ability (ERA)? Researchers compared a group of children who received the intervention (experimental group) with a control group that did not, to see whether improvements in ERA relate to higher prosocial behavior and fewer behavioral difficulties. Participants were asked to: Complete the DANVA-2-RV, a standardized tool to assess nonverbal emotion recognition, updated and validated on the study sample; Complete Raven's Colored Progressive Matrices, to measure nonverbal IQ; Have their behavior assessed via the SDQ - Teacher Version, filled out by their classroom teachers. A total of 140 children from four schools were enrolled. Participants were assigned non-randomly to an experimental or control group. Six teachers were involved in the behavioral assessments. The study is concluded. Expected outcomes include: A negative correlation between prosocial behavior and emotional confusion; A weak or non-significant relationship between nonverbal intelligence and emotion recognition ability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
Last Updated

July 31, 2025

Status Verified

January 1, 2023

Enrollment Period

28 days

First QC Date

July 23, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

Emotion Recognition AbilityProsocial BehaviorNonverbal IntelligencePrimary School Children

Outcome Measures

Primary Outcomes (1)

  • Change in Emotion Recognition Accuracy Between Groups

    Measured using the DANVA-2-RV. Emotion recognition accuracy scores (correct identification of basic emotions) will be compared between the intervention and control groups.

    Pre-test at Month 0, Intervention begins at Month 6, Post-test at 3 months after intervention (Month 9)

Secondary Outcomes (2)

  • Cross-Sectional Observation of Behavioral Profiles

    Single time point at study entry (Month 0).

  • Cross-Sectional Observation of Cognitive Profiles

    Single time point at study entry (Month 0).

Study Arms (2)

Emotion Recognition Training Group

EXPERIMENTAL
Behavioral: Emotion Recognition Training Program: A structured school-based intervention designed to enhance children's ability to recognize emotions through facial expressions, tone of voice, and body language.

No Intervention Control Group

ACTIVE COMPARATOR
Behavioral: No Intervention: Observational Cohort

Interventions

Emotion Recognition Training Program Integrated CASEL-based activities with CBT principles and digital tools to enhance emotional attribution and recognition in primary school children. The intervention consisted of three structured activities based on the CASEL framework (Collaborative for Academic, Social, and Emotional Learning), integrated with cognitive-behavioral principles inspired by the model of Albert Ellis. Sessions included interactive use of digital whiteboards and narrative tools (e.g., emotion-themed interactive stories), aimed at improving children's ability to attribute emotions to others and to emotionally evaluate events. In addition, a neurostimulative component was included, exposing children to visual stimuli with either neutral or fear-inducing emotional valence. Participants were asked to rate the perceived emotional intensity, supporting the development of self-regulation and emotional differentiation.

Emotion Recognition Training Group

Control group received no intervention in order to serve as a baseline for comparison, isolating the effects of the emotion recognition training on behavioral and cognitive outcomes.

No Intervention Control Group

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children enrolled in primary school (ages 6-9)
  • Parental/guardian informed consent obtained
  • Teacher agreement to complete SDQ - Teacher Version
  • Availability for participation in both pre- and post-assessment sessions
  • No diagnosed cognitive, psychiatric, or neurological disorders

You may not qualify if:

  • Documented diagnosis of neurodevelopmental disorders (e.g., ASD, ADHD, intellectual disability)
  • Severe visual, auditory, or motor impairments affecting test participation
  • Incomplete parental consent or teacher refusal to collaborate
  • Absence from school during key phases of assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alessandro De Santis

Foggia, Apulia, 71121, Italy

Location

Related Publications (5)

  • Naumann S, Bayer M, Kirst S, van der Meer E, Dziobek I. A randomized controlled trial on the digital socio-emotional competence training Zirkus Empathico for preschoolers. NPJ Sci Learn. 2023 Jun 19;8(1):20. doi: 10.1038/s41539-023-00169-8.

    PMID: 37336872BACKGROUND
  • Wells AE, Hunnikin LM, Ash DP, van Goozen SHM. Children with Behavioural Problems Misinterpret the Emotions and Intentions of Others. J Abnorm Child Psychol. 2020 Feb;48(2):213-221. doi: 10.1007/s10802-019-00594-7.

    PMID: 31686284BACKGROUND
  • Collaborative for Academic, Social, and Emotional Learning (CASEL). CASEL Guide to Schoolwide SEL Implementation. Chicago, IL: CASEL; 2020.

    BACKGROUND
  • Song JH, Colasante T, Malti T. Helping yourself helps others: Linking children's emotion regulation to prosocial behavior through sympathy and trust. Emotion. 2018 Jun;18(4):518-527. doi: 10.1037/emo0000332. Epub 2017 Jun 5.

    PMID: 28581324BACKGROUND
  • Izard C, Fine S, Schultz D, Mostow A, Ackerman B, Youngstrom E. Emotion knowledge as a predictor of social behavior and academic competence in children at risk. Psychol Sci. 2001 Jan;12(1):18-23. doi: 10.1111/1467-9280.00304.

    PMID: 11294223BACKGROUND

Related Links

MeSH Terms

Conditions

Antisocial Personality DisorderNonverbal CommunicationAltruism

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersCommunicationBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Inclusion 4 Children

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 31, 2025

Study Start

February 1, 2023

Primary Completion

March 1, 2023

Study Completion

June 1, 2024

Last Updated

July 31, 2025

Record last verified: 2023-01

Locations