NCT03767647

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 7, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2018

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

December 5, 2018

Last Update Submit

December 11, 2018

Conditions

Keywords

emotional intelligencestudentsrandomized clinical trialschools

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 weeks

Secondary Outcomes (7)

  • Elevation of levels of general mood subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire

    6 weeks

  • Elevation of levels of adaptability subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire

    6 weeks

  • Elevation of levels of stress management subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire

    6 weeks

  • Elevation of levels of interpersonal skills subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire

    6 weeks

  • Elevation of levels of intrapersonal skills subscale with EQi-YV ("Emotional Quotient Inventory: youth version") questionnaire

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Receives 6 lessons in 6 different weeks on Emotional Intelligence

Behavioral: Emotional Intelligence lessons

Control group

NO INTERVENTION

Receives no intervention.

Interventions

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.

Intervention group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario José Germain

Leganés, Madrid, 28911, Spain

Location

Study Officials

  • Blanca Navarro Peral

    Nurse resident in Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Resident in Mental Health

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

September 7, 2018

Primary Completion

October 22, 2018

Study Completion

October 30, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations