- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05255250
PLAYshop: A Parent-focused Physical Literacy Intervention for Early Childhood
The PLAYshop program is a novel, brief, theory-based, parent-focused physical literacy intervention designed to address this major public health issue of childhood physical inactivity and to support families.
Primary Research Question: Does the PLAYshop program increase preschool-aged children's physical literacy, including fundamental movement skills and motivation and enjoyment, compared to controls?
Study Overview
Status
Intervention / Treatment
Detailed Description
The overall goal for the proposed study is to examine the efficacy of the PLAYshop program, a novel, brief, theory-based, parent-focused physical literacy intervention, on child- and family-specific outcomes.
Research Questions:
Primary: Does the PLAYshop program increase preschool-aged children's physical literacy, including fundamental movement skills and motivation and enjoyment, compared to controls? Secondary: Does the PLAYshop program increase preschool-aged children's physical activity and co-participation in physical activity with parents, compared to controls? Tertiary: 1) Does the PLAYshop program increase parents' capability, motivation, and opportunity to support preschool-aged children's physical literacy development, compared to controls? 2) What is the level of, and factors that influence, implementation at the family and program delivery level?
Hypotheses:
Increases in preschool-aged children's fundamental movement skills, motivation and enjoyment, physical activity, and parent-child co-participation in physical activity will be greater in the intervention group, compared to the control group. Additionally, increase in parents' capability, motivation, and opportunity to support preschool-aged children's physical literacy development will be greater in the intervention group, compared to the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6W 1J9
- Kinesiology, Sport, and Recreation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 3-5 years and their parents
- Living in non-rural areas of Alberta or British Columbia, Canada as defined by Statistics Canada
Exclusion Criteria:
- Children diagnosed with developmental delay or disorder/condition that may affect gross motor development or limit their ability to be physically active.
- Families with parents who do not comfortably speak or read English.
- Families that do not have access to a smartphone/tablet with camera and microphone.
- Families that have participated in prior PLAYshop pilot and feasibility trials.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PLAYshop Intervention
Participants will receive a 60 minute virtual physical literacy workshop, an equipment goody-bag with basic play equipment and printed resources, and access to a digital app with an online toolkit and four bi-weekly boosters lessons.
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The intervention includes: 1. Educational Training - the 60 min virtual workshop will be delivered by a trained facilitator.
Parents will be introduced to physical literacy via education, group discussion, and active participation in fundamental movement skills (FMS) based activities with their child.
2. Distribution of Education Resources- Parents will be sent physical literacy and physical activity printed resources.
3. Material resources -parents will also be provided a bag of inexpensive active play equipment (e.g., ball, bean bag, balloons).
4. Provide Follow-up Support- After the workshop, participants will gain access to an app with an online toolkit including new active play ideas, tips, and equipment they can make at home for active play.
Additionally, participants will receive four bi-weekly booster lessons that include key workshop messages, support and encouragement for parents, reflection and check-in questions, and new activities to try with their child.
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No Intervention: Control
Participants will receive the 60 minute virtual physical literacy workshop, equipment goody-bag, and access to the digital app after completing 2-month follow-up measures.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in children's physical literacy (fundamental movement skills)
Time Frame: Baseline and 2 month follow-up
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Children's fundamental movement skills, including two manipulative skills (i.e., overhand throw, underhand throw), two locomotor skills (i.e., horizontal jump, hop), and one balance/stability skill (i.e., one leg balance), will be assessed in a recorded virtual meeting.
The skills are from the Test of Gross Motor Development (TGMD) and the Movement Assessment Battery for Children-Second Edition (MABC-2).
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Baseline and 2 month follow-up
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Change in children's physical literacy (motivation and enjoyment; parental report)
Time Frame: Baseline and 2 month follow-up
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Children's motivation and enjoyment will be assessed via a parental questionnaire that includes items from the Preschool Physical Literacy Assessment (Pre PLAy).
This scale includes 4 items with values of 1-5; higher values mean more motivation and enjoyment.
Citation: Cairney et al. (2018)
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Baseline and 2 month follow-up
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Change in children's physical literacy (enjoyment; child report)
Time Frame: Baseline and 2 month follow-up
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Children's enjoyment will also be assessed via self-report using an adapted Five Degrees of Happiness Likert scale for children.
This scale includes 1 item with a value of 1-5; a higher value means more enjoyment.
Citation: Hall et al. (2016)
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Baseline and 2 month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in children's physical activity
Time Frame: Baseline and 2 month follow-up
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Children's physical activity will be assessed with Actigraph wGT3X-BT accelerometers worn for 7 consecutive days.
Validated cut-points for preschool-aged children will be used to classify each 15 second count into sedentary time or physical activity.
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Baseline and 2 month follow-up
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Change in parent-child co-participation in physical activity (accelerometer)
Time Frame: Baseline and 2 month follow-up
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Parent-child co-participation in physical activity will be assessed with Actigraph wGT3X-BT accelerometers worn for 7 consecutive days by children and designated parents.
Validated cut-points for preschool-aged children and adults will be used to classify each 15 second count into sedentary time or physical activity.
The Bluetooth proximity detection feature on the accelerometer will be enabled to determine the presence (e.g., same room in a house, at the park together) or absence of close proximity between two accelerometers.
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Baseline and 2 month follow-up
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Change in parent-child co-participation in physical activity (questionnaire)
Time Frame: Baseline and 2 month follow-up
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Parent-child co-participation in physical activity will also be assessed with a parental questionnaire.
This scale includes 4 items with values of 1-5; higher values mean more co-participation in PA.
Citation: Mâsse et al., 2020
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Baseline and 2 month follow-up
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Change in parental physical activity modelling
Time Frame: Baseline and 2 month follow-up
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Parental physical activity modelling will be assess via a parental questionnaire.
This scale includes 3 items with values of 1-4: higher values mean higher modelling.
Citation: Davison et al., 2011
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Baseline and 2 month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in parents' capability to support preschool-aged children's physical literacy development
Time Frame: Baseline (all), immediately after workshop, approximately 1-2 weeks after baseline (intervention), one week after baseline (control), 2-month follow-up (all)
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Parental capability (i.e., knowledge), will be assessed via a parental questionnaire.
This scale includes 9 items with values of 1-5; higher values mean more capability.
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Baseline (all), immediately after workshop, approximately 1-2 weeks after baseline (intervention), one week after baseline (control), 2-month follow-up (all)
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Change in parents' motivation to support preschool-aged children's physical literacy development
Time Frame: Baseline (all), immediately after workshop, approximately 1-2 weeks after baseline (intervention), one week after baseline (control), 2-month follow-up (all)
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Parental motivation (i.e., confidence (11 items), beliefs (4 items), outcome expectations (3 items), intentions (2 items), perceived behavioural control (4 items)) will be assessed via a parental questionnaire.
Citation for beliefs and outcome expectations: Heitzler et al., 2006.
Items have values of 1-5; higher values mean more parental motivation.
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Baseline (all), immediately after workshop, approximately 1-2 weeks after baseline (intervention), one week after baseline (control), 2-month follow-up (all)
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Change in parents' opportunity to support preschool-aged children's physical literacy development
Time Frame: Baseline (all), immediately after workshop, approximately 1-2 weeks after baseline (intervention), one week after baseline (control), 2-month follow-up (all)
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Parental opportunity (e.g., perceived availability of resources (1 item), perceived barriers (5 items)) will be assessed via a parental questionnaire.
Items have values of 1-5; higher values mean less parental opportunity.
Citation for perceived barriers: Heitzler et al., 2006
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Baseline (all), immediately after workshop, approximately 1-2 weeks after baseline (intervention), one week after baseline (control), 2-month follow-up (all)
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Implementation: satisfaction and perceived usefulness (questionnaire)
Time Frame: Intervention group: Immediately after the workshop
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Satisfaction and perceived usefulness of the intervention will be assessed via a parental questionnaire in the intervention group only.
This scale includes 3 items with values of 1-5; higher values mean more satisfaction and perceived usefulness.
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Intervention group: Immediately after the workshop
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Implementation: satisfaction and perceived usefulness (parental interview)
Time Frame: Intervention group: 2-month follow-up
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Satisfaction and perceived usefulness of the intervention will also be explored via brief semi-structured interviews with parents from the intervention group.
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Intervention group: 2-month follow-up
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Implementation: facilitators and barriers (parental interview)
Time Frame: Intervention group: 2-month follow-up
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Implementation facilitators and barriers will be explored via brief semi-structured interviews with parents from the intervention group.
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Intervention group: 2-month follow-up
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Implementation: facilitators and barriers (workshop leader interview)
Time Frame: At study completion, approximately 1 year from first workshop.
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Implementation facilitators and barriers will be explored via brief semi-structured interviews with workshop leaders.
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At study completion, approximately 1 year from first workshop.
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Implementation: dose (parental interview)
Time Frame: Intervention group: 2-month follow-up
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The dose of the intervention will be explored via brief semi-structured interviews with parents from the intervention group.
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Intervention group: 2-month follow-up
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Implementation: dose (app check-in questions)
Time Frame: Intervention group: Bi-weekly after workshop (i.e., 1, 3, 5, and 7 weeks)
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The dose of the intervention will be assessed via check-in questions as part of the booster lessons in the intervention group.
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Intervention group: Bi-weekly after workshop (i.e., 1, 3, 5, and 7 weeks)
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Implementation: dose (app usage data)
Time Frame: Intervention group: 2-month follow-up
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The dose of the intervention will be assessed via tracking of app usage in the intervention group.
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Intervention group: 2-month follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patti-Jean Naylor, PhD, University of Victoria
- Principal Investigator: Valerie Carson, PhD, University of Alberta
- Principal Investigator: Sam Liu, PhD, University of Victoria
- Principal Investigator: Ryan Rhodes, PhD, University of Victoria
Publications and helpful links
General Publications
- Masse LC, O'Connor TM, Lin Y, Carbert NS, Hughes SO, Baranowski T, Beauchamp MR. The physical activity parenting practices (PAPP) item Bank: a psychometrically validated tool for improving the measurement of physical activity parenting practices of parents of 5-12-year-old children. Int J Behav Nutr Phys Act. 2020 Nov 4;17(1):134. doi: 10.1186/s12966-020-01036-0.
- Heitzler CD, Martin SL, Duke J, Huhman M. Correlates of physical activity in a national sample of children aged 9-13 years. Prev Med. 2006 Apr;42(4):254-60. doi: 10.1016/j.ypmed.2006.01.010. Epub 2006 Feb 20.
- Hall, L., Hume, C., & Tazzyman, S. (2016). Five Degrees of Happiness: Effective Smiley Face Likert Scales for Evaluating with Children. In Proceedings of the The 15th International Conference on Interaction Design and Children (311-321). ACM.
- Cairney J, Clark HJ, James ME, Mitchell D, Dudley DA, Kriellaars D. The Preschool Physical Literacy Assessment Tool: Testing a New Physical Literacy Tool for the Early Years. Front Pediatr. 2018 Jun 7;6:138. doi: 10.3389/fped.2018.00138. eCollection 2018.
- Davison KK, Li K, Baskin ML, Cox T, Affuso O. Measuring parental support for children's physical activity in white and African American parents: the Activity Support Scale for Multiple Groups (ACTS-MG). Prev Med. 2011 Jan;52(1):39-43. doi: 10.1016/j.ypmed.2010.11.008. Epub 2010 Nov 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PLAYshop2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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