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

Health Behavior Clinical Trial

— CRECES  

Official title:

Pilot Study of CRECES Programme: Promoting Healthy Life Styles in Children Through the Social and Emotional Competence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975544
• Other study ID #: 70801
• Status: Completed
• Phase: N/A
• First received: November 15, 2016
• Last updated: November 28, 2016
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Emotional Intelligence
• Health Behavior

Intervention

Behavioral:
• CRECES programme
The first unit of CRECES programme was implemented in 8 sessions. Each session was 40-50 minutes long and delivered during four weeks. Parents were provided with home-extension activities.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Fundación Caja Navarra

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of the programme by children and parents who took part in	Explored by semi-structured interviews with children and parents	post-test (1 month)	Yes
Other	Efficacy on children social and emotional skills and healthy habits adoption perceived by parents	Explored by semi-structured interviews with parents	post-test (1 month)	No
Other	Feasibility of the programme's implementation	Examined by researcher's field diary	Baseline	No
Primary	Changes on children's emotional knowledge	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).	Baseline; Post-test (1 month), 7 months follow-up	No
Secondary	Changes on the total and parcial dimensions (cooperation, independence and interaction) of children's basic social skills	Reported by parents by Preschool and Kindergarten Behavior Scales (PKBS-II; Merrell, 2003).	Baseline, post-test (1 month) and 7 months follow-up	No
Secondary	Changes on the total and parcial dimensions (comfort, satisfaction, resilience, risk avoidance and achievement) of children's health profile	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)	Baseline, post-test (1 month) and 7 months follow-up	No