EmotionsI4CNCT07097090
Improving Emotion Recognition Ability to Support Social Development in Children: A Quasi-Experimental Study
A study testing 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. in people with Emotions and Facial Emotion Recognition, run by University of Foggia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotions, Facial Emotion Recognition, Antisocial Behavior
- What is being tested?
- 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.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inclusion 4 Children (Https://inclusion4children.it)
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:
Read more
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.
- Conditions
- Emotions, Facial Emotion Recognition, Antisocial Behavior, Nonverbal Communication, Intelligence
- Being tested
- 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: Observational Cohort
- Keywords
- Emotion Recognition Ability, Prosocial Behavior, Nonverbal Intelligence, Primary School Children
- Medical subject headings
- Antisocial Personality Disorder, Nonverbal Communication, Altruism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Behavioural
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.
No Intervention: Observational CohortBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Emotion Recognition Training Group | Experimental | Not described Receives: 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 | Not described Receives: Behavioral: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Observation of behavioral difficulties and prosocial behaviors (via SDQ - Teacher Version).
Measured: Single time point at study entry (Month 0).
Cross-Sectional Observation of Cognitive Profiles
Observation of nonverbal intelligence (via Raven's Colored Progressive Matrices).
Measured: Single time point at study entry (Month 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Feb 2023
- Primary completion1 Mar 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EmotionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro De Santis, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097090
- Sponsor's protocol ID
- 43681
- Acronym
- I4C
- Status last verified
- Jan 2023
- First submitted
- 23 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the involvement of children in a protected age range, the dataset contains sensitive information that cannot be publicly shared in its raw form. However, the research team is willing to provide de-identified and anonymized data upon reasonable request, ensuring that all personally identifiable or sensitive details are masked in accordance with ethical standards and institutional policies.
Publications
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.
PubMed 37336872Wells 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.
PubMed 31686284Collaborative for Academic, Social, and Emotional Learning (CASEL). CASEL Guide to Schoolwide SEL Implementation. Chicago, IL: CASEL; 2020.
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.
PubMed 28581324Izard 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.
PubMed 11294223
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inclusion 4 Children (Https://inclusion4children.it)
- ClinicalTrials.gov ID
- NCT07097090
- Acronym / sponsor ID
- I4C / 43681
- Conditions
- Emotions, Facial Emotion Recognition, Antisocial Behavior, Nonverbal Communication, Intelligence
- Keywords
- Emotion Recognition Ability, Prosocial Behavior, Nonverbal Intelligence, Primary School Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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. | Behavioural | Emotion Recognition Training Group |
| No Intervention: Observational CohortControl 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. | Behavioural | No Intervention Control Group |
Primary outcome
Change in Emotion Recognition Accuracy Between Groups
Time frame: Pre-test at Month 0, Intervention begins at Month 6, Post-test at 3 months after intervention (Month 9)
Measured using the DANVA-2-RV. Emotion recognition accuracy scores (correct identification of basic emotions) will be compared between the intervention and control groups.
2 secondary outcomes
Cross-Sectional Observation of Behavioral Profiles
Time frame: Single time point at study entry (Month 0).
Cross-Sectional Observation of Cognitive Profiles
Time frame: Single time point at study entry (Month 0).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 37336872Naumann 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.
- Background: PubMed 31686284Wells 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.
- BackgroundCollaborative for Academic, Social, and Emotional Learning (CASEL). CASEL Guide to Schoolwide SEL Implementation. Chicago, IL: CASEL; 2020.
- Background: PubMed 28581324Song 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.
- Background: PubMed 11294223Izard 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.
- Individual participant dataSharing planned: Undecided. Due to the involvement of children in a protected age range, the dataset contains sensitive information that cannot be publicly shared in its raw form. However, the research team is willing to provide de-identified and anonymized data upon reasonable request, ensuring that all personally identifiable or sensitive details are masked in accordance with ethical standards and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. in people with Emotions and Facial Emotion Recognition, run by University of Foggia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotion Recognition Accuracy Between Groups (time frame: Pre-test at Month 0, Intervention begins at Month 6, Post-test at 3 months after intervention (Month 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07097090, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.