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

Primary Purpose

Executive Function, Problem Behavior

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Finnish ENGAGE together
Sponsored by
Niilo Mäki Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Executive Function focused on measuring Preschool, Self-regulation, Executive function, Problem behavior, Training, Play-based

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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:

-

Sites / Locations

  • Niilo Mäki Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

play sessions included as a part of normal early childhood education; parents' evening for all parents; parents' group for the parents of children that have difficulties in self-regulation and that are offered more individualized small group activity

normal early childhood education

Outcomes

Primary Outcome Measures

School Situations Questionnaire
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
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
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 Outcome Measures

Go/No-go iPad task
A game-like task measuring response inhibition from the Early Years Toolbox. In the task, children are supposed to catch the fish and avoid the sharks. This measurement concerns children selected for the second phase of the intervention due to exhibiting difficulties in self-regulation.
Working memory iPad task
A game-like task ("Mr. Ant") from the Early Years Toolbox. In the task, children are supposed to remember the locations of stickers placed on an ant character. This measurement concerns children selected for the second phase of the intervention due to exhibiting difficulties in self-regulation.

Full Information

First Posted
January 26, 2021
Last Updated
April 5, 2022
Sponsor
Niilo Mäki Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04752605
Brief Title
Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
Official Title
Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niilo Mäki Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Executive Function, Problem Behavior
Keywords
Preschool, Self-regulation, Executive function, Problem behavior, Training, Play-based

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
play sessions included as a part of normal early childhood education; parents' evening for all parents; parents' group for the parents of children that have difficulties in self-regulation and that are offered more individualized small group activity
Arm Title
Control
Arm Type
No Intervention
Arm Description
normal early childhood education
Intervention Type
Behavioral
Intervention Name(s)
Finnish ENGAGE together
Intervention Description
Early childhood education workers play games with children during day care. The games (e.g. ball games, puzzles, Simon says) target children's executive functions and self-regulatory skills, e.g. inhibition, attention, and emotion regulation. The first phase of the intervention (6 weeks) includes play sessions (15 minutes each day) for all children as well as a parents' evening to encourage playing at home. In the second phase (8 weeks), more individualized small group play sessions (3 times a week, 30 minutes at once) are arranged for the children that show difficulties in self-regulation after the first phase. Also, a parents' group including 6 group sessions and 2 phone calls is arranged for their parents in this phase. The participating parents are asked to play the games for 20 minutes each day with their children. During the group meetings, the parents share their experiences of playing at home and receive support and guidance from 2 health care professionals.
Primary Outcome Measure Information:
Title
School Situations Questionnaire
Description
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.
Time Frame
Change from baseline at 1,5, 4, and 7 months
Title
Home Situations Questionnaire
Description
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.
Time Frame
Change from baseline at 1,5, 4, and 7 months
Title
Attention and Executive Function Rating Inventory -Preschool
Description
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.
Time Frame
Change from baseline at 1,5, 4, and 7 months
Secondary Outcome Measure Information:
Title
Go/No-go iPad task
Description
A game-like task measuring response inhibition from the Early Years Toolbox. In the task, children are supposed to catch the fish and avoid the sharks. This measurement concerns children selected for the second phase of the intervention due to exhibiting difficulties in self-regulation.
Time Frame
Change from baseline at 2 months
Title
Working memory iPad task
Description
A game-like task ("Mr. Ant") from the Early Years Toolbox. In the task, children are supposed to remember the locations of stickers placed on an ant character. This measurement concerns children selected for the second phase of the intervention due to exhibiting difficulties in self-regulation.
Time Frame
Change from baseline at 2 months
Other Pre-specified Outcome Measures:
Title
Abbreviated Acceptability Rating Profile
Description
Intervention providers and parents assess the acceptability of the intervention after the first phase of the intervention. Possible values range between 1 and 6. Higher values mean greater acceptability.
Time Frame
The questionnaire is filled at 1,5 months
Title
Abbreviated Acceptability Rating Profile
Description
Intervention providers and parents assess the acceptability of the intervention after the second phase of the intervention. Possible values range between 1 and 6. Higher values mean greater acceptability.
Time Frame
The questionnaire is filled at 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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: -
Facility Information:
Facility Name
Niilo Mäki Institute
City
Jyväskylä
Country
Finland

12. IPD Sharing Statement

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

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