Executive FunctionNCT04752605
Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
A study testing Finnish ENGAGE together in people with Executive Function and Problem Behavior, run by Niilo Mäki Institute at 1 site in Finland.
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… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Executive Function, Problem Behavior
- What is being tested?
- Finnish ENGAGE together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Executive Function, Problem Behavior
- Being tested
- Finnish ENGAGE together
- Keywords
- Preschool, Self-regulation, Executive function, Problem behavior, Training, Play-based
- Medical subject headings
- Problem Behavior, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finnish ENGAGE togetherBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Finnish ENGAGE together |
| Control | No intervention | normal early childhood education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 1,5, 4, and 7 months
Secondary outcomes (2)
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.
Measured: Change from baseline at 2 months
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.
Measured: Change from baseline at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niilo Mäki Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752605
- Sponsor's protocol ID
- 4-C7291
- Status last verified
- Apr 2022
- First submitted
- 26 Jan 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Play-Based Training on Executive Functioning in Pre-School Children
- ClinicalTrials.gov ID
- NCT04752605
- Acronym / sponsor ID
- 4-C7291
- Conditions
- Executive Function, Problem Behavior
- Keywords
- Preschool, Self-regulation, Executive function, Problem behavior, Training, Play-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Niilo Mäki InstituteUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Finnish ENGAGE togetherplay 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 |
| Control | No intervention | –normal early childhood education |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finnish ENGAGE togetherEarly 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. | Behavioural | Intervention |
Primary outcome
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.
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.
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.
2 secondary outcomes
Go/No-go iPad task
Time frame: Change from baseline at 2 months
Working memory iPad task
Time frame: Change from baseline at 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finnish ENGAGE together in people with Executive Function and Problem Behavior, run by Niilo Mäki Institute at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School Situations Questionnaire (time frame: Change from baseline at 1,5, 4, and 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.