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

NCT04752605 | Completed

• 1 other identifier: 4-C7291
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Executive Function; Problem Behavior

Keywords

Preschool; Self-regulation; Executive function; Problem behavior; Training; Play-based

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Go/No-go iPad task

  Change from baseline at 2 months

• Working memory iPad task

  Change from baseline at 2 months

Other Outcomes (2)

• Abbreviated Acceptability Rating Profile

  The questionnaire is filled at 1,5 months

• Abbreviated Acceptability Rating Profile

  The questionnaire is filled at 4 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Finnish ENGAGE together

Control

NO INTERVENTION

normal early childhood education

Interventions

Finnish ENGAGE together BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Niilo Mäki Institute: lead

Study Sites (1)

Niilo Mäki Institute

Jyväskylä, Finland

Location

MeSH Terms

Conditions

Problem Behavior; Self-Control

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 12, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

FI (1)