Clinical trial NCT04752605: 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
Overall status: COMPLETED
Phase: NA
Conditions: Executive Function
Problem Behavior
Keywords: Preschool
Self-regulation
Executive function
Problem behavior
Training
Play-based
Lead sponsor: Niilo Mäki Institute
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

-

Primary outcomes:
measure: School Situations Questionnaire
timeFrame: Change from baseline at 1,5, 4, and 7 months
measure: Home Situations Questionnaire
timeFrame: Change from baseline at 1,5, 4, and 7 months
measure: Attention and Executive Function Rating Inventory -Preschool
timeFrame: Change from baseline at 1,5, 4, and 7 months
Secondary outcomes:
measure: Go/No-go iPad task
timeFrame: Change from baseline at 2 months
measure: Working memory iPad task
timeFrame: Change from baseline at 2 months
Other outcomes:
measure: Abbreviated Acceptability Rating Profile
timeFrame: The questionnaire is filled at 1,5 months
measure: Abbreviated Acceptability Rating Profile
timeFrame: The questionnaire is filled at 4 months
Locations:
city: Jyväskylä
country: Finland
facility: Niilo Mäki Institute
Study officials:
References: