- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03767647
Effects of an Educational Intervention on Emotional Intelligence in School Students (EMCONMIGO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Leganés, Madrid, Spain, 28911
- Hospital Universitario José Germain
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Receives 6 lessons in 6 different weeks on Emotional Intelligence
|
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.
|
No Intervention: Control group
Receives no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
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.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elevation of levels of general mood subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Elevation of levels of adaptability subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Elevation of levels of stress management subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Elevation of levels of interpersonal skills subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Elevation of levels of intrapersonal skills subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Elevation of levels of cognitive re-evaluation subscale with ERQ-CA ("Emotional Regulation Questionary") questionnaire
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Elevation of levels of emotional suppression subscale with ERQ-CA ("Emotional Regulation Questionary") questionnaire
Time Frame: 6 weeks
|
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.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Blanca Navarro Peral, Nurse resident in Mental Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- pos05/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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