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

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra (Other)
Overall Status
Completed
CT.gov ID
NCT02975544
Collaborator
Fundación Caja Navarra (Other)
37
2
10.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CRECES programme
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Pilot Study of CRECES Programme: Promoting Healthy Life Styles in Children Through the Social and Emotional Competence
Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

  2. 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)

Other Outcome Measures

  1. Acceptability of the programme by children and parents who took part in [post-test (1 month)]

    Explored by semi-structured interviews with children and parents

  2. Efficacy on children social and emotional skills and healthy habits adoption perceived by parents [post-test (1 month)]

    Explored by semi-structured interviews with parents

  3. Feasibility of the programme's implementation [Baseline]

    Examined by researcher's field diary

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra
  • Fundación Caja Navarra

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elena Bermejo, Principal Investigator, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT02975544
Other Study ID Numbers:
  • 70801
First Posted:
Nov 29, 2016
Last Update Posted:
Nov 29, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Elena Bermejo, Principal Investigator, Clinica Universidad de Navarra, Universidad de Navarra

Study Results

No Results Posted as of Nov 29, 2016