NCT02462733

Brief Summary

Self-control has become a strong predictor of academic success and life outcomes. Early childhood development research indicates that greater self-control can lead to better health, greater wealth, and less propensity to engage in criminal activity. This study seeks to assess the strength of the play-based "Tools of the Mind" (TOM) program in improving preschoolers self-control. It will compare TOM to an alternative play-based program, called "Playing to Learn" (PTL), implemented in most YMCA Canada childcare settings across the country. This study hypothesizes that measures of self-control and other measures of social behavior and academic success in preschoolers after two years in the TOM program will be greater than measures of self-control and other measures of social behavior and academic success in preschoolers in the PTL program after two-years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

May 25, 2015

Last Update Submit

October 24, 2016

Conditions

Keywords

Self-controlPreschoolersTools of the MindPlaying to Learn

Outcome Measures

Primary Outcomes (1)

  • Inhibitory Control

    Inhibitory Control will be measured through the Day/Night task (Gerstadt et al., 1994). Children are presented with a white card depicting a yellow sun and a black card depicting a white moon and stars. They are then instructed to play a "silly" game in which they must say "day" when they see the night card and "night" when they see the day card. Hence, they must inhibit the pre potent response to say the word that is associated with the picture, and say the opposite word. Children receive 16 test trials in which the cards are presented in a fixed pseudorandom order. There are no breaks or rule reminders. Day/Night is a well-established and widely used task, ubiquitous in the developmental and developmental neuroscience literature. The task takes less than 5 minutes to complete.task.

    Change from baseline to 18 months

Secondary Outcomes (4)

  • Early Childhood Development - Theory of Mind

    Change from baseline to 18 months

  • Early Childhood Development - Language

    Change from baseline to 18 months

  • Early Childhood Development - Reading

    Change from baseline to 18 months

  • Early Childhood Development - Mathematics

    Change from baseline to 18 months

Study Arms (2)

Tools of the Mind (TOM)

ACTIVE COMPARATOR

These 10 classrooms will be exposed to the TOM program.

Behavioral: Tools of the Mind (TOM)

Playing to Learn (PTL)

ACTIVE COMPARATOR

These 10 classrooms will be exposed to the PTL program.

Behavioral: Playing to Learn (PTL)

Interventions

TOM is play-based but features explicit, scripted, teacher-directed activities aimed specifically at helping to improve children's self-control skills. Early evidence supports the program efficacy and suggests benefits for children's development more generally (including language, reading and mathematics).

Tools of the Mind (TOM)

PTl is a play based preschool program now in wide use in YMCA childcare settings across Canada (and some in the United States). The activities in PTL are child initiated and are not prescribed. Teachers are trained to observe children at play and to capitalize on learning opportunities as they arise.

Playing to Learn (PTL)

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born between July 2007 and December 2008, inclusive (3 to 4 years of age in 2011)
  • Sufficient command of English to understand the teacher's instructions (as judged by their teacher, English as a Second Language - ELL - students will be included provided they meet this criterion)
  • Signed parental consent form

You may not qualify if:

  • Known uncorrected sensory, neurological, or physical impairments that might prevent full participation in the activities outlined by either program (again, as judged by the teacher)
  • Insufficient command of English
  • No parental consent given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Bruce Ferguson, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR
  • Tracy Solomon, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR
  • Rosemary Tannock, MD

    OISE, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

May 25, 2015

First Posted

June 4, 2015

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 25, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations