NCT02225236

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

August 22, 2014

Last Update Submit

January 25, 2018

Conditions

Executive Dysfunction

Keywords

executive functioningmetacognitionself-regulationpreschoolers

Outcome Measures

Primary Outcomes (1)

  • 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

    Outcome assessment (~9 months after initial assessment)

Secondary Outcomes (4)

  • Clinical Evaluation of Language Fundamentals - Preschool, Second Edition - Concepts and Following Directions

    Outcome evaluation (~9 months after baseline evaluation)

  • NEPSY- Attention/Executive Function subtests

    Outcome (~9 months after baseline evaluation)

  • Shape School

    Outcome (~9 months after baseline evaluation)

  • Swanson, Kotkin, Agler, M-Flynn, Pelham (SKAMP) Teacher Rating Scale

    Outcome (~9 months after baseline evaluation)

Study Arms (2)

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.

Behavioral: Classroom Intervention

No treatment control

NO INTERVENTION

No intervention

Interventions

Classroom InterventionBEHAVIORAL
Classroom Intervention

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children in preschool classrooms in selected schools.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schools in the Archdiocese of Cincinnati to be determined

Cincinnati, Ohio, United States

Location

Related Publications (1)

  • 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.

    PMID: 29902951DERIVED

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Leanne Tamm, Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

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

August 22, 2014

First Posted

August 26, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations

US(1)