Clinical trial NCT02975544: An Exploratory Trial of a Health Education Programme Based on the Social and Emotional Competence in Children
Official title: Pilot Study of CRECES Programme: Promoting Healthy Life Styles in Children Through the Social and Emotional Competence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Emotional Intelligence
Keywords: social and emotional competence
healthy lifestyles
children
educational programme
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Fundación Caja Navarra
First posted: 2016-11-29
Enrollment: 37
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes on children's emotional knowledge
timeFrame: Baseline; Post-test (1 month), 7 months follow-up
Secondary outcomes:
measure: Changes on the total and parcial dimensions (cooperation, independence and interaction) of children's basic social skills
timeFrame: Baseline, post-test (1 month) and 7 months follow-up
measure: Changes on the total and parcial dimensions (comfort, satisfaction, resilience, risk avoidance and achievement) of children's health profile
timeFrame: Baseline, post-test (1 month) and 7 months follow-up
Other outcomes:
measure: Acceptability of the programme by children and parents who took part in
timeFrame: post-test (1 month)
measure: Efficacy on children social and emotional skills and healthy habits adoption perceived by parents
timeFrame: post-test (1 month)
measure: Feasibility of the programme's implementation
timeFrame: Baseline
Locations:
Study officials:
affiliation: University of Navarra
name: Elena Bermejo Martins, Nursing, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bermejo-Martins E, Mujika A, Iriarte A, Pumar-Mendez MJ, Belintxon M, Ruiz-Zaldibar C, Lopez-Dicastillo O. Social and emotional competence as key element to improve healthy lifestyles in children: A randomized controlled trial. J Adv Nurs. 2019 Aug;75(8):1764-1781. doi: 10.1111/jan.14024. Epub 2019 Jul 8.