Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02462733 |
| Other study ID # |
1000029127 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2015 |
| Last updated |
October 24, 2016 |
| Start date |
April 2012 |
| Est. completion date |
July 2013 |
Study information
| Verified date |
October 2016 |
| Source |
The Hospital for Sick Children |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Ethics Review Committee |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
We will compare growth in self-control and in related areas of development (mathematics,
reading, language, social reasoning) in children taught with TOM to children instructed with
Playing to Learn (PTL; Eden & Huggins, 2001) - a play based preschool program now in wide
use in YMCA childcare settings across Canada (and some in the United States). PTL was
developed by an educator/author and by the General Manager of Education, Development, and
Research at YMCA Canada. It was selected as the comparison program because it is also a
coherent play-based program. In previous studies involving TOM, the comparison programs have
differed from TOM on a number of dimensions and often have not been play-based (e.g. Diamond
et al., 2007), posing challenges for the interpretation of the results.
In contrast to TOM, 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. For example, children who are using blocks to build a fort, may be encouraged
to think about how the size and arrangement of the blocks influences its final structure, to
count the number of blocks involved, the number of children the structure can accommodate as
well as the structure's affordances. Instruction in self-control is an emergent property of
these child-initiated activities. For example, teachers may help children to solve the
problem of too few blocks for all of the children interested in the block building activity,
by organizing themselves into teams and taking turns. They may assist in conflict resolution
by helping children to generate alternative solutions such as stopping to think about the
conflict and using words instead of impulsive actions to express their dissatisfaction.
Comparison of the development of self-control in children taught with the TOM and PTL
programs will thus provide a sense of the benefits (if any) to children of a more focused,
teacher-directed approach to teaching self-control.
The primary research question is: Do preschool children taught with the TOM program show
greater growth in self-control than their peers who are taught with the PTL program over a
two year period? The secondary research question is: If there is a significant difference
between the TOM and PTL children in growth in self-control, does that enhanced growth confer
benefits for development more generally (for children's cognitive, social, linguistic and
academic development)? The proposed efficacy study will be conducted in partnership with the
YMCA organization of the greater Toronto area. The study duration will be two years as the
TOM program follows a 2-year in-service training plan and children are not expected to reach
maximal benefits from exposure to the program until the second year. Twenty YMCA sites will
participate, with one participating preschool class (2 teachers) at each site. The criteria
for inclusion on the list is that the site must have at least one preschool class,
instruction must take place in English, and the preschoolers currently in attendance must
not be slated to attend full-day Kindergarten (as per the province's roll out plan) within
the study period. Ten sites (classes) will be randomly assigned to either the TOM or the PTL
conditions. The YMCA has agreed to provide data on the proportion of families served at each
site who pay full fees and those whose fees are subsidized. These data will serve as a proxy
for the socioeconomic status of the two groups. Random assignment should result in no
difference between the two groups in the mean proportion of families paying full fees.
Both groups of teachers will receive training (TOM) or in-service workshops (PTL) in their
respective programs, in each of the two years of the study. Training for TOM will be
conducted as required by the program developers; two days of training in the fall and three
full days of following up training - one in each in the late fall, winter and spring - of
the two years of the study. Professionals from the TOM organization will conduct the TOM
training as well as follow-up coaching and assistance to the TOM teachers as needed.
Teachers new to the YMCA receive two full days of PTL training. All receive in service
workshops every year as well as ongoing in- class teacher training and coaching. The
workshops and ongoing assistance are administered by senior YMCA training staff, with a
wealth of experience with the PTL program. Every effort will be made to align the amount and
the timing of the training/workshops in the two groups. The teachers in both groups will
instruct their students according to their assigned programs for the entire study period (2
years), including the summertime.
Program fidelity will be assessed in two ways: 1). using the teacher assessment data
generated by experienced evaluators from each program, as per standard practice for both the
TOM and PTL programs and 2). by our own classroom observations. Both programs have
established methods of assessing teacher fidelity (Bodrova & Leong, 2007; Eden & Huggins,
2001). Successful implementation of the TOM program takes several months to achieve and is
said to reach acceptable fidelity levels around March of the first year. Fidelity is
assessed periodically, over the first two years of implementation. The YMCA conducts teacher
assessments that include PTL fidelity measures annually, around April. We will use the
results from the early spring (April) assessments in the two years of the study, for both
programs, to determine the teachers' implementation fidelity to their respective programs.
Although both organizations report that reaching acceptable levels of fidelity is not
typically problematic, the PTL and TOM assessments will be conducted using different
methods, criteria and instruments for documentation. These will capture fidelity to the
respective programs - as judged by trained observers from each program - however, they will
not address either the differences or possible similarities between programs. This
information that could provide critical insights into the mechanisms that might sub-serve
different success rates (effects on the development of self-regulation) in the two programs,
should such differences arise. Hence, we will also conduct our own observations. A member of
our research team will visit each site for a full day and document their observations using
a Preschool Observation Measure (POM), which is currently being developed by our research
team. The POM contains a list of observable activities and practices one would expect to see
in a typical TOM classroom, in a typical PTL classroom and more general practices one would
expect to see in any quality child care setting. The observers will rate each classroom with
respect to how well the teachers administer these activities. The idea is that TOM teachers
should rate more highly on the TOM practices and PTL teachers more highly on the PTL
activities, while the two groups may overlap substantially on the more general teaching
practices. The observations and ratings will be done in the spring (April - May) of each of
the two years of the study.
Participants. Preschool classes and their teachers will be randomly selected from the
preschool classrooms at the target sites (n = 10 TOM and 10 PTL classes, 20 TOM and 20 PTL
teachers, N= 20 classes and 40 teachers). The criteria for participation in the study for
the teachers are: valid Ontario Early Childhood Education certification; permanent,
full-time status; no plan to take a leave of absence during the study period; proficiency in
spoken English; no known uncorrected hearing or vision impairments; no previous experience
with the TOM program; and a signed teacher consent form. As the teachers already provide
instruction in English, the English proficiency and no uncorrected impairments requirements
are not expected to rule out any teachers currently working at the YMCA.
Twelve to fourteen children, per participating preschool class, will be randomly selected
for tracking over the course of the study (n's = 120-140 children in each condition, N =
240-280). Boys and girls will be equally represented. The criteria for student participation
are: 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); no 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) and a signed parental consent form. We will obtain information
regarding the above teacher and student criteria from the YMCA.
As our primary research question concerns the relative efficacy of TOM for improving
self-regulation skills, the primary outcome measures will be two tasks that tap inhibitory
control (see below). Our secondary research question concerns the implications for enhancing
self-control for children's development more generally including their cognitive,
social/emotional, language, and academic development as well their attention skills and
overall adjustment. Accordingly, we will measure change over the study period in the
development of children's classroom and home behaviour, attention skills, theory of mind,
receptive and expressive vocabulary, mathematics, as well as drawing, writing and pre/early
literacy skills, all of which have been linked to executive function (see e.g. McInnes,
Humphries, Hogg-Johnson & Tannock, 2003 and Martinussen, Hayden, Hogg-Johnson & Tannock,
2005, for poor attention skills and Attention Deficit Hyperactivity Disorder (ADHD); Kyte,
Goodyer & Sahakian, 2005 for inhibitory control and depression; Carlson & Moses, 2001 for
theory of mind and executive function; Carlson & Moses, 2001 and Hughes, 1998 for inhibitory
control and language, and Blair & Razza, 2007 and Bull & Scerif, 2001 for inhibitory control
and reading and mathematics skills). All of the measures will be administered in the fall
and the spring of the two years of the study (2011-2012 and 2012-2013).
Children will be tested individually, in a quiet location in their preschool, during regular
preschool hours. We will coordinate with the teachers to ensure minimal disruption to their
classrooms during the four data collection time points. The total test time for the children
is 35-45 minutes at each time point (spring and fall of the two study years), which will be
divided into two test sessions of about 25 minutes each (excluding the time for the
drawings/play plans which will be administered as part of the PTL and TOM curricula). To
help maintain motivation, the tasks will be presented in the form of games, breaks will be
given between tasks as needed and children will be praised for their efforts. Previous
experience has shown that children in this age group find such "games" highly enjoyable and
that 30 minutes of focused attention to a variety of tasks is well within the attention
range of most preschoolers, when working with experienced experimenters.
