- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04752605
Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
April 5, 2022 updated by: Niilo Mäki Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jyväskylä, Finland
- Niilo Mäki Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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
|
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.
|
No Intervention: Control
normal early childhood education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline at 1,5, 4, and 7 months
|
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.
|
Change from baseline at 1,5, 4, and 7 months
|
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.
|
Change from baseline at 1,5, 4, and 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Go/No-go iPad task
Time Frame: Change from baseline at 2 months
|
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.
|
Change from baseline at 2 months
|
Working memory iPad task
Time Frame: Change from baseline at 2 months
|
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.
|
Change from baseline at 2 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abbreviated Acceptability Rating Profile
Time Frame: The questionnaire is filled at 1,5 months
|
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.
|
The questionnaire is filled at 1,5 months
|
Abbreviated Acceptability Rating Profile
Time Frame: The questionnaire is filled at 4 months
|
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.
|
The questionnaire is filled at 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
January 26, 2021
First Submitted That Met QC Criteria
February 9, 2021
First Posted (Actual)
February 12, 2021
Study Record Updates
Last Update Posted (Actual)
April 6, 2022
Last Update Submitted That Met QC Criteria
April 5, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-C7291
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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