Evaluation of the Move 2 Learn (M2L) Program for Young Children: A Randomized Wait-list Controlled Trial

Design: The study will use a randomized wait-list controlled design. Children will be randomized to either the intervention arm or the wait-list control arm with a 1:1 ratio. Children randomized to the intervention arm will enter the Move 2 Learn (M2L) intervention during the first 10-12 weeks of the study period; children randomized to the wait-list control arm will not receive any intervention during the first 10-12 weeks of the study (the wait-list control period), then will enter into a modified M2L intervention during the second 10 to 12 weeks of the study. All children will be assessed 3 times at 10-12-week intervals. The intervention arm will be assessed before and immediately after they receive the intervention, and at a 10-12-week follow-up. The wait-list control group will be assessed at baseline, immediately before receiving the intervention (10-12 weeks following) and after they receive the intervention.

Children will be randomized 1:1 to either the intervention or wait-list control group. Simple randomization will be completed using a computer algorithm. After confirming eligibility and obtaining verbal consent, a research assistant will send the complete list of study IDs to an independent biostatistician who will use a computer algorithm to randomly assign the child to the intervention or to the wait-list control group. Sealed, opaque, and numbered envelops will be prepared with their allocation details (e.g. if randomized to the intervention arm, information regarding the location and time of the intervention will be provided).

Intervention: The Move 2 Learn (M2L) program (both the original and the modified program) will be run out of the gym space provided in-kind by the Faculty of Kinesiology and Physical Education at the University of Toronto. This behavioral program will run for 60 minutes once per week for 10 consecutive weeks and will consist of three components: direct movement skill instruction, unstructured exploratory free-play, and in interactive storybook reading activity. There is active involvement of at least one parent/caregiver in the direct instruction and reading components and parents/caregivers are provided with handouts outlining specific strategies to implement for at-home practice of the activities. Each week, parents will be verbally encouraged to practice these skills at home with their parents.

The participants randomized to the wait-list control group will not receive any intervention during the control period (between time 1 and time 2 assessments. After their time 2 assessment is complete, participants will receive a modified version of the M2L program. All in-sessions components of the M2L program will be implemented with the exception of the parent handouts and the verbal encouragement to practice at-home between sessions Assessments: At the time 1 appointment, children will be administered the gross motor subscales of the Peabody Developmental Motor Scales-2 (PDMS-2; Folio & Fewell, 2000), the perceived physical competence subscale of the Pictorial Scale (PPC) of Perceived Competence and Social Acceptance for Young Children-Preschool-Kindergarten version (PSCS-PK; Harter & Pike, 1984), the Phonological Awareness Literacy Screening: Preschool (PALS-PK; Invernizzi, Sullivan, Meier, & Swank, 2004), the Preschool Word and Print Awareness Test (PWPA; Justice & Ezell, 2002), and the Picture Deletion Task for Preschoolers (PDTP; Byrne, DeWolfe, & Bawden, 1998; Corkum, Byrne, & Ellsworth, 1995). Parents will complete a demographic questionnaire (see Demographic Survey for Parents), and a parental engagement questionnaire that asks about the use of specific activities to promote motor skill and early literacy skill development (see Parental Engagement Survey) and the Behaviour Rating Inventory of Executive Function®-Preschool Version (BRIEF-P; Gioia, Espy, & Isquith, 2001). On completion of testing, children will be fitted with an accelerometer; parents will be instructed on its proper use and provided with a diary to track wear time (e.g., time of day put on, time of day removed). After 7 days, parents will mail back the the accelerometer(s) and diary (see Accelerometer Log). At each subsequent appointment (time 2 and time 3), all outcomes described above will be measured again (see Figure 2) except for the parent demographic survey and the BRIEF-P. Each study appointment will take approximately 1.5 hours.

All outcomes will be assessed at the INfant and Child Health (INCH) Lab at the University of Toronto by trained graduate students, blind to the intervention status of the participants.