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Completed

NCT Number: NCT02975544

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

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.

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Key information

Conditions

Health Behavior Behavior Emotional Intelligence

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRECES programme

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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)

Other outcomes

  1. 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

  2. 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

  3. Feasibility of the programme's implementation

    Time frame: Baseline

    Examined by researcher's field diary

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • Fundación Caja Navarra

Registry information

Official study title

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

Acronym: CRECES

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Nov 29, 2016
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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