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Clinical Trials/NCT04752605
NCT04752605
Completed
Not Applicable

Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children

Niilo Mäki Institute1 site in 1 country180 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Executive Function
Sponsor
Niilo Mäki Institute
Enrollment
180
Locations
1
Primary Endpoint
School Situations Questionnaire
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to examine the effectiveness of a play-based intervention designed to support the development of executive functioning in 3-5-year-old children. The intervention is implemented in the day care setting as a part of early childhood education in collaboration with parents and local healthcare and social welfare workers. The study hypothesizes that the intervention as an add-on to normal early childhood education brings added benefits to the development of children's executive functioning in comparison to early childhood education without the add-on.

Detailed Description

This cluster-randomized controlled trial examines the effectiveness of a play-based intervention, added as a component to normal early childhood education, in supporting the development of executive functioning in 3-5-year-old children in comparison to early childhood education without such a component. 12 day care centers in Finland have been randomized to intervention (n = 6) and control (n = 6) groups. The children in the intervention group will receive the intervention in the spring of 2021, and the children in the control group will be on the wait list and receive the intervention in the fall of 2021 after measurements. In the day care centers belonging to the intervention group, play sessions supporting the development of children's executive functioning will be arranged as a part of normal early childhood education. The pre-selected games target children's executive functions and self-regulatory abilities, e.g. inhibition, attention, working memory and emotion regulation. The first phase of the intervention (6 weeks) includes play sessions for all children as well as a parents' evening. In the second phase (8 weeks), more individualized play sessions are arranged for the children that exhibit difficulties in executive functions after the first phase. Also, a parents' group is arranged in this phase, which will expand the daily play activities to homes. Day care education personnel and parents fill out questionnaires concerning children's behavior at 4 time points, and the children participating in the second phase (small group activity) will complete two iPad tasks before and after the small group activity. The study takes place in Finland.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Niilo Mäki Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children born between 4.6.2015 - 11.1.2018
  • For the second phase (small group activity): children must exhibit problems in executive functions (e.g. inattention, hyperactivity, impulsivity) and be considered as potentially benefitting from additional practice as assessed by early childhood educators

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

School Situations Questionnaire

Time Frame: Change from baseline at 1,5, 4, and 7 months

Early childhood education workers assess whether children exhibit problem behaviors in different preschool situations and the severity of the problems. Possible values range between 0 and 9. Higher values mean more severe problems.

Home Situations Questionnaire

Time Frame: Change from baseline at 1,5, 4, and 7 months

Parents assess whether children exhibit problem behaviors in different home situations and the severity of the problems. Possible values range between 0 and 9. Higher values mean more severe problems.This measurement concerns the children who take part in the first phase of the intervention.

Attention and Executive Function Rating Inventory -Preschool

Time Frame: Change from baseline at 1,5, 4, and 7 months

Early childhood education workers assess the extent to which children have problems on different areas of executive functioning (e.g. distractibility, directing and sustaining attention, planning). Possible values range between 0 and 3. Higher values mean more severe problems.

Secondary Outcomes

  • Working memory iPad task(Change from baseline at 2 months)
  • Go/No-go iPad task(Change from baseline at 2 months)

Study Sites (1)

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