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

Executive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752605
• Other study ID #: 4-C7291
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Niilo Mäki Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Executive Function
• Problem Behavior

Intervention

Behavioral:
• Finnish ENGAGE together
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.

Locations

Country	Name	City	State
Finland	Niilo Mäki Institute	Jyväskylä

Sponsors (1)

Lead Sponsor	Collaborator
Niilo Mäki Institute

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Abbreviated Acceptability Rating Profile	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
Other	Abbreviated Acceptability Rating Profile	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
Primary	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.	Change from baseline at 1,5, 4, and 7 months
Primary	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.	Change from baseline at 1,5, 4, and 7 months
Primary	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.	Change from baseline at 1,5, 4, and 7 months
Secondary	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.	Change from baseline at 2 months
Secondary	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.	Change from baseline at 2 months