An Exploratory Trial of a Health Education Programme Based on the Social and Emotional Competence in Children

Not Applicable

Completed

• Conditions: Health Behavior; Emotional Intelligence
• Interventions: Behavioral: CRECES programme

• Registration Number: NCT02975544
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

The purpose of this study was to evaluate whether an intervention based on the social and emotional competence development improves the healthy lifestyles adoption in young children.

Detailed Description

This study has designed, implemented and evaluated an intervention to promote healthy lifestyles in children addressing the development of the social and emotional competence. This research followed the first three stages of the Medical Research Council framework for complex interventions: the theoretical, modeling phase and the exploratory trial. A randomised control trial with 37 children (5 y 6 years old) was conducted at the exploratory trial. The first unit was implemented in 8 sessions. A multi-method and multi-informant approach was used to assess the preliminary efficacy, acceptability and feasibility of the programme.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-04
• Study Completion: 2016-01
• Status Verified: 2016-11
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-28
• Last Update Submitted: 2016-11-28
• Study First Posted: 2016-11-29
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Children aged 5 and 6 enrolled in a public school in the north of Spain

Exclusion Criteria

• Children with severe cognitive or language special needs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	CRECES programme	Received CRECES programme during 5 weeks as part of the extracurricular plan

Primary Outcome Measures

Name	Time	Method
Changes on children's emotional knowledge	Baseline; Post-test (1 month), 7 months follow-up	Directly measured on children by PERCEVAL test (Mestre, J. M., Guil, R., Martínez-Cabañas, F., Escandón, C. L., y Gonzalez de la Torre, G. (2011).

Secondary Outcome Measures

Name	Time	Method
Changes on the total and parcial dimensions (cooperation, independence and interaction) of children's basic social skills	Baseline, post-test (1 month) and 7 months follow-up	Reported by parents by Preschool and Kindergarten Behavior Scales (PKBS-II; Merrell, 2003).
Changes on the total and parcial dimensions (comfort, satisfaction, resilience, risk avoidance and achievement) of children's health profile	Baseline, post-test (1 month) and 7 months follow-up	Reported by children and parents by Child Health and Illness Profile-CHILDREN Edition (CHIP-CE; Rajmil, L., Serra-Sutton, V., Alonso, J., Herdman, M., Riley, A., y Starfield, B. (2003)