Executive DysfunctionNCT02225236
Improving Self-regulation & School Readiness in Preschoolers
A study testing Classroom Intervention in people with Executive Dysfunction, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This project will develop and evaluate the initial effectiveness of an intervention training executive functioning, metacognition, and self-regulation in preschoolers attending certain high poverty Cincinnati preschools. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Dysfunction
- What is being tested?
- Classroom Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2017
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- All children in preschool classrooms in selected schools.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Schools in the Archdiocese of Cincinnati to be determined
Cincinnati, Ohio
About this study
This project will develop and evaluate the initial effectiveness of an intervention training executive functioning, metacognition, and self-regulation in preschoolers attending certain high poverty Cincinnati preschools. Studies show that these skills are critical for school performance, and that children with better executive functioning have better long term outcomes. It is also important to intervene early when children are most likely to profit because their brains are rapidly developing. There are some promising programs targeting these skills in preschoolers, but few are available to teachers for implementation in the classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based program for the preschool classroom environment, and 2) to test the feasibility and initial impact of the adapted program on executive functioning and school readiness in schools with a high proportion of children from low income families.
Read the detailed description
We propose to translate a promising intervention, Executive-function Training for Attention and Metacognition (ETAM), originally developed for use in a clinic setting, to be delivered in the school setting, ultimately by teachers. Specifically, we propose to develop a curriculum that can be added to the classroom curriculum which will target the development of self-regulation and metacognition in preschoolers. Thus the purpose of the study is to 1) develop a teacher training program based on the principles we have found to be effective in a parent-based intervention and 2) test the feasibility and initial efficacy (i.e., reduced disruptive behaviors and increased school readiness) of the program in children from low income families. We will randomly assign 6 preschools to receive the teacher training component and 6 schools to serve as a control group (i.e., will not receive the intervention). We will conduct assessments on all preschoolers in the classroom prior to delivering the teacher training (i.e., beginning of the school year), provide the training to preschoolers in classrooms randomized to the active intervention group, and then conduct assessments at the end of the school year. Our primary aims are to assess the feasibility of a program designed to train teachers to incorporate the principles of the training program into the daily classroom environment, and to assess whether the program improves executive functioning and functional outcomes [i.e., Attention/Deficit-Hyperactivity Disorder (ADHD) symptoms, academic readiness, social competence], as compared to outcomes of children in the control schools. Although study personnel will be responsible for delivery of the intervention, preschool teachers will be closely involved in the process to provide ongoing feedback regarding the study intervention.
- Conditions
- Executive Dysfunction
- Being tested
- Classroom Intervention
- Keywords
- executive functioning, metacognition, self-regulation, preschoolers
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classroom InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Classroom Intervention | Experimental | The intervention focuses on training executive functioning (e.g., working memory and inhibition) and metacognition (i.e., the ability to predict, check, monitor, coordinate and control cognitive operations) using play activities and structured language and reinforcement. Receives: Behavioral: Classroom Intervention |
| No treatment control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Rating Inventory of Executive Function-Preschool Version
Parents and teachers will complete this rating scale assessing executive function behaviors in the home and school environments, yielding T-scores on several subscales, including Inhibit, Shift, Emotional Control, Working Memory, Plan/Organize, Inhibitory Self-Control Index, Flexibility Index, Emergent Metacognition Index, and a Global Executive Composite. The scale has adequate reliability and validity as assessed in two- to five-year-olds
Measured: Outcome assessment (~9 months after initial assessment)
Secondary outcomes (4)
Clinical Evaluation of Language Fundamentals - Preschool, Second Edition - Concepts and Following Directions
The Concepts and Following Directions subtest is a measure of auditory and visual attention. This subtest requires the child to interpret, recall, and execute oral commands of increasing length and complexity that contain concepts of functional language. A subscale score is computed for Concepts and Following Directions. Across ages (i.e., 3- to 7-year-olds), internal consistency ranged from .78 to .85 with an average of .82.
Measured: Outcome evaluation (~9 months after baseline evaluation)
NEPSY- Attention/Executive Function subtests
The Visual Attention subtest is a measure of inhibition, scanning, vigilance, and impulsivity. This subtest is divided into two tasks (e.g., cats and faces, or bunnies and cats). The child is shown an exemplar at the top of the page (e.g., bunny) and is asked to circle all the bunnies amongst a number of other stimuli on the rest of the page as quickly as possible. The Statue subtest is a measure of motor persistence and inhibition. The child is asked to assume a pose and remain in it with their eyes closed for 75 seconds, ignoring distractors occurring at regular intervals. A subscale score is computed for each subtest. Reliabilities for the NEPSY at ages 3 through 7 are > .70.
Measured: Outcome (~9 months after baseline evaluation)
Shape School
This assessment is a developmentally appropriate task developed for preschoolers assessing inhibition and switching. The child is presented with a colorful storybook of colorful circle and square figures and is administered 4 conditions (control, inhibit, switch, concurrent/both). In the control condition, the child names the colors of the figures as fast as possible. In the inhibit (response suppression) condition, the child only named the colors of the figures with happy faces and not frustrated faces. In the switch (attention control) condition, the child names the shapes of figures wearing hats. In the concurrent condition, the child is asked to name the figures (color or shape), who were both wearing hats and had happy faces. Cronbach's alpha coefficients for each condition exceeds 0.71.
Measured: Outcome (~9 months after baseline evaluation)
Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Teacher Rating Scale
Teachers will be asked to complete the SKAMP to measure impairments in classroom functioning related to disruptive behaviors.
Measured: Outcome (~9 months after baseline evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Executive DysfunctionStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Brady Education Foundation
- Responsible party
- Sponsor
- Investigators
- Leanne Tamm, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225236
- Sponsor's protocol ID
- FP00006613
- Status last verified
- Jan 2018
- First submitted
- 22 Aug 2014
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Tamm L, Peugh J. Concordance of teacher-rated and performance-based measures of executive functioning in preschoolers. Child Neuropsychol. 2019 Apr;25(3):410-424. doi: 10.1080/09297049.2018.1484085. Epub 2018 Jun 14.
PubMed 29902951
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self-regulation & School Readiness in Preschoolers
- ClinicalTrials.gov ID
- NCT02225236
- Acronym / sponsor ID
- FP00006613
- Conditions
- Executive Dysfunction
- Keywords
- executive functioning, metacognition, self-regulation, preschoolers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Brady Education Foundation
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Aug 2014 (estimated)
- 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.
This project will develop and evaluate the initial effectiveness of an intervention training executive functioning, metacognition, and self-regulation in preschoolers attending certain high poverty Cincinnati preschools. Studies show that these skills are critical for school performance, and that children with better executive functioning have better long term outcomes. It is also important to intervene early when children are most likely to profit because their brains are rapidly developing. There are some promising programs targeting these skills in preschoolers, but few are available to teachers for implementation in the classroom setting. The specific aims of this study are: 1) to adapt a promising clinic-based program for the preschool classroom environment, and 2) to test the feasibility and initial impact of the adapted program on executive functioning and school readiness in schools with a high proportion of children from low income families.
Detailed description
We propose to translate a promising intervention, Executive-function Training for Attention and Metacognition (ETAM), originally developed for use in a clinic setting, to be delivered in the school setting, ultimately by teachers. Specifically, we propose to develop a curriculum that can be added to the classroom curriculum which will target the development of self-regulation and metacognition in preschoolers. Thus the purpose of the study is to 1) develop a teacher training program based on the principles we have found to be effective in a parent-based intervention and 2) test the feasibility and initial efficacy (i.e., reduced disruptive behaviors and increased school readiness) of the program in children from low income families. We will randomly assign 6 preschools to receive the teacher training component and 6 schools to serve as a control group (i.e., will not receive the intervention). We will conduct assessments on all preschoolers in the classroom prior to delivering the teacher training (i.e., beginning of the school year), provide the training to preschoolers in classrooms randomized to the active intervention group, and then conduct assessments at the end of the school year. Our primary aims are to assess the feasibility of a program designed to train teachers to incorporate the principles of the training program into the daily classroom environment, and to assess whether the program improves executive functioning and functional outcomes [i.e., Attention/Deficit-Hyperactivity Disorder (ADHD) symptoms, academic readiness, social competence], as compared to outcomes of children in the control schools. Although study personnel will be responsible for delivery of the intervention, preschool teachers will be closely involved in the process to provide ongoing feedback regarding the study intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classroom Intervention | Experimental | Behavioral: Classroom InterventionThe intervention focuses on training executive functioning (e.g., working memory and inhibition) and metacognition (i.e., the ability to predict, check, monitor, coordinate and control cognitive operations) using play activities and structured language and reinforcement. |
| No treatment control | No intervention | –No intervention |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children in preschool classrooms in selected schools.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Classroom Intervention | Behavioural | Classroom Intervention |
Primary outcome
Behavior Rating Inventory of Executive Function-Preschool Version
Time frame: Outcome assessment (~9 months after initial assessment)
Parents and teachers will complete this rating scale assessing executive function behaviors in the home and school environments, yielding T-scores on several subscales, including Inhibit, Shift, Emotional Control, Working Memory, Plan/Organize, Inhibitory Self-Control Index, Flexibility Index, Emergent Metacognition Index, and a Global Executive Composite. The scale has adequate reliability and validity as assessed in two- to five-year-olds
4 secondary outcomes
Clinical Evaluation of Language Fundamentals - Preschool, Second Edition - Concepts and Following Directions
Time frame: Outcome evaluation (~9 months after baseline evaluation)
NEPSY- Attention/Executive Function subtests
Time frame: Outcome (~9 months after baseline evaluation)
Shape School
Time frame: Outcome (~9 months after baseline evaluation)
Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Teacher Rating Scale
Time frame: Outcome (~9 months after baseline evaluation)
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 29 Jan 2018.
- Derived from this study: PubMed 29902951Tamm L, Peugh J. Concordance of teacher-rated and performance-based measures of executive functioning in preschoolers. Child Neuropsychol. 2019 Apr;25(3):410-424. doi: 10.1080/09297049.2018.1484085. Epub 2018 Jun 14.
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Goal-Directed Sedation in Mechanically Ventilated Infants and Children
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Executive Function Intervention for Children With Complex Congenital Heart Disease
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COMPuter-assisted Self-training to Improve EXecutive Function
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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.
Leanne Tamm, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classroom Intervention in people with Executive Dysfunction, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 1 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 29 Jan 2018. 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 United States. 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?
Behavior Rating Inventory of Executive Function-Preschool Version (time frame: Outcome assessment (~9 months after initial assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225236, which also lists 1 linked publication.
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 29 Jan 2018.