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

November 28, 2016 updated by: Elena Bermejo, Clinica Universidad de Navarra, Universidad de Navarra

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Received CRECES programme during 5 weeks as part of the extracurricular plan
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.
No Intervention: Control group
Continued with their habitual school routine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on children's emotional knowledge
Time Frame: 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).
Baseline; Post-test (1 month), 7 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on the total and parcial dimensions (cooperation, independence and interaction) of children's basic social skills
Time Frame: Baseline, post-test (1 month) and 7 months follow-up
Reported by parents by Preschool and Kindergarten Behavior Scales (PKBS-II; Merrell, 2003).
Baseline, post-test (1 month) and 7 months follow-up
Changes on the total and parcial dimensions (comfort, satisfaction, resilience, risk avoidance and achievement) of children's health profile
Time Frame: 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)
Baseline, post-test (1 month) and 7 months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the programme by children and parents who took part in
Time Frame: post-test (1 month)
Explored by semi-structured interviews with children and parents
post-test (1 month)
Efficacy on children social and emotional skills and healthy habits adoption perceived by parents
Time Frame: post-test (1 month)
Explored by semi-structured interviews with parents
post-test (1 month)
Feasibility of the programme's implementation
Time Frame: Baseline
Examined by researcher's field diary
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Fundación Caja Navarra

Investigators

  • Principal Investigator: Elena Bermejo Martins, Nursing, PhD, University of Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 70801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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