Emotional IntelligenceEMCONMIGONCT03767647
Effects of an Educational Intervention on Emotional Intelligence in School Students
A study testing Emotional Intelligence lessons in people with Emotional Intelligence, run by Hospital Severo Ochoa at 1 site in Spain.
Trial summary
Objectives: Evaluate the effect on emotional intelligence levels of an educational intervention. Design: Randomized Clinical Trial Methods: An intervention on emotional intelligence was conducted in a Primary School. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Intelligence
- What is being tested?
- Emotional Intelligence lessons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteSpain
- Study dates
- 7 Sep 2018to 30 Oct 2018
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be on 5th or 6th year of Spanish Primary Education.
- Accept informed consent of the study.
- Be able to read, understand and answer both questionnaires
Who cannot join
- Revoque informed consent.
- Be in two different classes from the school.
- Absence to 25% or more of the lessons.
- Answer less than 80% of any questionnaire.
- Not completing both questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Educational Intervention on Emotional Intelligence in School Students: Randomized Clinical Trial
Objectives: Evaluate the effect on emotional intelligence levels of an educational intervention.
Design: Randomized Clinical Trial
Methods: An intervention on emotional intelligence was conducted in a Primary School. Students were recruited and randomized into intervention or control group (no intervention) by class (cluster). Total sample was 179. Results were measured with EQi-YV and ERQ-CA questionnaires. Statistical analysis was made with Student's t and Mann-Whitney's U tests.
- Conditions
- Emotional Intelligence
- Being tested
- Emotional Intelligence lessons
- Keywords
- emotional intelligence, students, randomized clinical trial, schools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Intelligence lessonsBehavioural
6 lessons were given to the students in separated weeks by the same investigator. Lessons were 45-60 minutes long and each one was dedicated to one of the main aspects of emotional intelligence.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Receives 6 lessons in 6 different weeks on Emotional Intelligence Receives: Behavioral: Emotional Intelligence lessons |
| Control group | No intervention | Receives no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevation of levels of Emotional Intelligence with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Increment of at least 3 points of median puntuation of emotional intelligence using EQi-YV questionnaire. Range of puntuations: 60-240 points. EQi-YV is the method in Spanish with higher internal and external validity to measure emotional intelligence in children and teenager population. The participants must show their degree of agreement with 60 items on a Likert scale of 4 points (1: never happens to me, 4: it always happens to me). It consists of 5 subscales: general mood, adaptability, stress management, interpersonal skills and intrapersonal skills. All negative punctuations were positivized for analisis (5-n). Total value is obtained by the sum of the items and reflects the level of emotional intelligence. A higher value means a better condition for the patient.
Measured: 6 weeks
Elevation of levels of Emotional Intelligence with ERQ-CA ("Emotional Regulation Questionary") questionnaire
Increment of at least 2 points of median emotional intelligence using ERQ-CA questionnaire. The ERQ-CA measures emotional regulation capacity, it has been validated in Spanish. ERQ-CA consists on 10 Likert items on a scale of 5 points (1: never happens to me; 5: it always happens to me). It is formed of two subscales: cognitive re-evaluation and emotional suppression. Total puntuation is obtained by the sum of the items and varies from 10 to 50. All negative puntuations were positivized for analisis (6-n). A higher value means a better condition for the patient.
Measured: 6 weeks
Secondary outcomes (7)
Elevation of levels of general mood subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Increment of at least 1.5 points of median puntuation of general mood subscale using EQi-YV questionnaire. Range of puntuations 14-56. The participants must show their degree of agreement with items on a Likert scale of 4 points (1: never happens to me, 4: it always happens to me). It consists on 14 items of general mood (items 1, 4, 9, 13,19, 23, 29, 32, 37, 40, 47, 50, 56, 60). All negative punctuations were positivized for analisis (5-n). Total value represents the level of general mood. A higher value means a better condition for the patient.
Measured: 6 weeks
Elevation of levels of adaptability subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Increment of at least 1.5 points of median puntuation of adaptability subscale using EQi-YV questionnaire. Range of puntuations 10-40. The participants must show their degree of agreement with items on a Likert scale of 4 points (1: never happens to me, 4: it always happens to me). It consists on 10 items of adaptability (items 12, 16, 22, 25, 30, 34, 38, 44, 48, 57). All negative punctuations were positivized for analisis (5-n). Total value represents the level of adaptability. A higher value means a better condition for the patient.
Measured: 6 weeks
Elevation of levels of stress management subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Increment of at least 1.5 points of median puntuation of stress management subscale using EQi-YV questionnaire. Range of puntuations 12-48. The participants must show their degree of agreement with items on a Likert scale of 4 points (1: never happens to me, 4: it always happens to me). It consists on 12 items of stress management (items 3, 6, 11, 15, 21, 26, 35, 39, 46, 49, 54, 58). All negative punctuations were positivized for analisis (5-n). Total value represents the level of stress management. A higher value means a better condition for the patient.
Measured: 6 weeks
Elevation of levels of interpersonal skills subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Increment of at least 1.5 points of median puntuation of interpersonal skills subscale using EQi-YV questionnaire. Range of puntuations 11-44. The participants must show their degree of agreement with items on a Likert scale of 4 points (1: never happens to me, 4: it always happens to me). It consists on 11 items of interpersonal skills (items 2, 5, 10, 14, 20, 24, 36, 41, 45, 55, 59). All negative punctuations were positivized for analisis (5-n). Total value represents the level of interpersonal skills. A higher value means a better condition for the patient.
Measured: 6 weeks
Elevation of levels of intrapersonal skills subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Increment of at least 1.5 points of median puntuation of intrapersonal skills subscale using EQi-YV questionnaire. Range of puntuations 6-24. The participants must show their degree of agreement with items on a Likert scale of 4 points (1: never happens to me, 4: it always happens to me). It consists on 6 items of intrapersonal skills (items 7, 17, 28, 31, 43, 53). All negative punctuations were positivized for analisis (5-n). Total value represents the level of intrapersonal skills. A higher value means a better condition for the patient.
Measured: 6 weeks
Elevation of levels of cognitive re-evaluation subscale with ERQ-CA ("Emotional Regulation Questionary") questionnaire
Increment of at least 1 point of median cognitive re-evaluation subscale using ERQ-CA questionnaire. Range of puntuations 6-30. The participants must show their degree of agreement with items on a Likert scale of 5 points (1: never happens to me; 5: it always happens to me). It consists on 6 items of cognitive re-evaluation (items 1, 3, 5, 7, 8, 10). All negative puntuations were positivized for analisis (6-n). Total value represents the level of cognitive re-evaluation. A higher value means a better condition for the patient.
Measured: 6 weeks
Elevation of levels of emotional suppression subscale with ERQ-CA ("Emotional Regulation Questionary") questionnaire
Increment of at least 1 point of median emotional suppression subscale using ERQ-CA questionnaire. Range of puntuations 4-20. The participants must show their degree of agreement with items on a Likert scale of 5 points (1: never happens to me; 5: it always happens to me). It consists on 4 items of emotional suppression (items 2, 4, 6, 9). All negative puntuations were positivized for analisis (6-n). Total value represents the level of emotional suppression. A higher value means a better condition for the patient.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start7 Sep 2018
- Primary completion22 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional IntelligenceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Severo Ochoa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca Navarro Peral, Hospital Severo Ochoa
- Investigators
- Blanca Navarro Peral, Principal investigator, Nurse resident in Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767647
- Sponsor's protocol ID
- pos05/18
- Acronym
- EMCONMIGO
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Educational Intervention on Emotional Intelligence in School Students: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03767647
- Acronym / sponsor ID
- EMCONMIGO / pos05/18
- Conditions
- Emotional Intelligence
- Keywords
- emotional intelligence, students, randomized clinical trial, schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Hospital Severo OchoaUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 6 Dec 2018 (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.
Objectives: Evaluate the effect on emotional intelligence levels of an educational intervention.
Design: Randomized Clinical Trial
Methods: An intervention on emotional intelligence was conducted in a Primary School. Students were recruited and randomized into intervention or control group (no intervention) by class (cluster). Total sample was 179. Results were measured with EQi-YV and ERQ-CA questionnaires. Statistical analysis was made with Student's t and Mann-Whitney's U tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Emotional Intelligence lessonsReceives 6 lessons in 6 different weeks on Emotional Intelligence |
| Control group | No intervention | –Receives no intervention. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Be on 5th or 6th year of Spanish Primary Education.
- Accept informed consent of the study.
- Be able to read, understand and answer both questionnaires
Key exclusion criteria (5 listed)
- Revoque informed consent.
- Be in two different classes from the school.
- Absence to 25% or more of the lessons.
- Answer less than 80% of any questionnaire.
- Not completing both questionnaires.
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 |
|---|---|---|
| Emotional Intelligence lessons6 lessons were given to the students in separated weeks by the same investigator. Lessons were 45-60 minutes long and each one was dedicated to one of the main aspects of emotional intelligence. | Behavioural | Intervention group |
Primary outcome
Elevation of levels of Emotional Intelligence with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time frame: 6 weeks
Increment of at least 3 points of median puntuation of emotional intelligence using EQi-YV questionnaire. Range of puntuations: 60-240 points. EQi-YV is the method in Spanish with higher internal and external validity to measure emotional intelligence in children and teenager population. The participants must show their degree of agreement with 60 items on a Likert scale of 4 points (1: never happens to me, 4: it always happens to me). It consists of 5 subscales: general mood, adaptability, stress management, interpersonal skills and intrapersonal skills. All negative punctuations were positivized for analisis (5-n). Total value is obtained by the sum of the items and reflects the level of emotional intelligence. A higher value means a better condition for the patient.
Elevation of levels of Emotional Intelligence with ERQ-CA ("Emotional Regulation Questionary") questionnaire
Time frame: 6 weeks
Increment of at least 2 points of median emotional intelligence using ERQ-CA questionnaire. The ERQ-CA measures emotional regulation capacity, it has been validated in Spanish. ERQ-CA consists on 10 Likert items on a scale of 5 points (1: never happens to me; 5: it always happens to me). It is formed of two subscales: cognitive re-evaluation and emotional suppression. Total puntuation is obtained by the sum of the items and varies from 10 to 50. All negative puntuations were positivized for analisis (6-n). A higher value means a better condition for the patient.
7 secondary outcomes
Elevation of levels of general mood subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time frame: 6 weeks
Elevation of levels of adaptability subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time frame: 6 weeks
Elevation of levels of stress management subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time frame: 6 weeks
Elevation of levels of interpersonal skills subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time frame: 6 weeks
Elevation of levels of intrapersonal skills subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time frame: 6 weeks
Elevation of levels of cognitive re-evaluation subscale with ERQ-CA ("Emotional Regulation Questionary") questionnaire
Time frame: 6 weeks
Elevation of levels of emotional suppression subscale with ERQ-CA ("Emotional Regulation Questionary") questionnaire
Time frame: 6 weeks
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 13 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Blanca Navarro Peral principal investigator
Nurse resident in Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Intelligence lessons in people with Emotional Intelligence, run by Hospital Severo Ochoa at 1 site in Spain.
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 3 inclusion and 5 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 13 Dec 2018. 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 Spain. 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?
Elevation of levels of Emotional Intelligence with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2018.