Evaluation of the Move 2 Learn (M2L) Program for Young Children
Condition: Motor Development; Physical Activity
Study type: Interventional

Summary: 
      Move 2 Learn (M2L) is a 10-week movement and pre-literacy program for preschool aged children
      and their parents designed to improve both movement and reading skills as well as support
      their overall cognitive, physical, and psychological development. This study will be using a
      randomized wait-list controlled trial design to evaluate the program on several outcomes:
      motor skills, pre-literacy skills, cognitive function, perceived physical competence, and
      physical activity. Children ages 3 to 4 years with typical development will be randomized to
      either start the program immediately or enter the wait-list control group to begin the
      program after a 10-week control period. The outcomes will be assessed for all children three
      times, at week 0, week 11, and week 21 to evaluate change over time in both groups.
    

Detailed description: 
      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.

      Measures: The primary outcomes include fundamental movement skills and pre-literacy skills.
      Movement skills will be assessed using the gross motor sub-scales of the Peabody
      Developmental Motor Scales - 2 (PDMS-2). The Preschool Word and Print Awareness Test (PWPA)
      and the Phonological Awareness Literacy Screening: Preschool (PALS-PK) to measure
      print-concept knowledge and alphabet knowledge, respectively. Secondary outcomes include
      physical activity, cognitive function, and self-perceived physical competence. 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.

      Motor Skill Proficiency: The gross motor subscales of the PDMS-2 (stationary performances,
      locomotion, and object manipulation) will be used to assess change in motor skill over the
      course of the study and will be administered by a trained graduate student blind to the
      intervention status of the participant. This tool is commercially available.

      Pre-literacy Skills: Emergent literacy skills that will be measured include print concepts
      and alphabet knowledge. The PALS-PK Upper-case Alphabet Recognition task will be used to
      measure children's alphabet knowledge. This tool is commercially available. Print awareness
      will be assessed using the PWPA. The assessment uses an interactive story book reading
      activity to test children on their knowledge of 14 print concepts, such as print
      directionality and print function (Justice & Ezell, 2002). This tool is freely available as
      it was published as an appendix in the Justice, Bowles, & Skibbe, 2006 article.

      Physical Activity: Accelerometry is an objective method of assessing free-moving physical
      activity, and is the method best-suited to measuring activity in young children. This study
      will use the Actigraph GT3X activity monitor, a light (27g) and small (3.8cm × 3.7cm × 1.8cm)
      device, secured to the child by a belt worn around the waist. A 3 s epoch will be used
      (Obeid, Nguyen, Gabel, & Timmons, 2011) and will record physical activity for 7 consecutive
      days (Trost, Pate, Freedson, Sallis, & Taylor, 2000).

      Executive Function: The BRIEF-P, a parent-report tool, will be used to assess children's
      trait executive function at week 0 (Sherman & Brooks, 2010). State executive function will be
      assessed using the Attention Sustained subtest 6 of the Leiter-3 test battery. The task
      requires children to view a target image (an animal) and identify the images that match among
      a set of distractor images as quickly as possible; there are 4 trials, each of which have a
      practice set. This tool is commercially available. To assess inhibition, the Head Toes Knees
      and Shoulders instrument will also be administered. This task requires Children are to play a
      game in which they must do the opposite of what the experimenter says. The experimenter
      instructs children to touch their head (or their toes), but instead of following the command,
      the children are supposed to do the opposite and touch their toes.

      Perceived Physical Competence: The PSCS-PK will be used to assess each child's level of
      perceived competence. There are physical competence subscale (6-items) will be administered.
      The scale is an extension of Harter's Perceived Competence Scale for Children (1982). This
      tool is freely available online.

      Demographic Factors: The baseline questionnaire will include questions about the parent and
      the child on age, gender, race/ethnicity, parental education and occupation, and household
      income. The questionnaire will be parent-completed.

      Parental Engagement: Parents will be asked about the use and the frequency of use, of
      specific activities that will be employed in our program. A parent-reported questionnaire
      specific to these activities has been created to determine if parents have been using these
      strategies before our program, and if they have incorporated them into their activities with
      their child after having completed the program.

      Parental Acceptability: Consenting parents will engage in a focus group, led by a
      facilitator. Staying consistent with the unstructured nature of a focus group, open-ended
      questions designed to initiate discussions surrounding their attitudes and opinions, likes
      and dislikes of the program will be asked. The discussion will be audio recorded and
      transcribed verbatim. Focus group transcriptions will be used to revise the program and its
      components to better serve the community.

      Analysis: Basic descriptive statistics of participating children and parents will be
      completed. Mixed effects models will be used to assess a group-by-time effect on all
      outcomes. All analyses will be conducted on an intention to treat basis.
    

Intervention name(s): Move 2 Learn
Intervention type(s): Behavioral
Intervention description(s): 10-week (1 hour/week) program designed to target fundamental movement and pre-literacy skills with active parent involvement.
Other intervention name(s): M2L
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Wait-list Controlled Design
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Pre-Literacy Skills