- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436197
The Expansion of a Parent-focused Physical Literacy Intervention for Early Childhood Called PLAYshop
The PLAYshop program is a novel, brief, theory-based, parent-focused physical literacy intervention, that can help mitigate the impacts of the COVID-19 pandemic on physical activity of children from diverse and vulnerable families who have been disproportionally affected by the COVID-19 Pandemic.
Primary Research Question: Among vulnerable families (e.g., lower socioeconomic status), does the PLAYshop program increase parental capability, opportunity, and motivation to support preschool-aged children's physical literacy development, compared to controls?
Study Overview
Status
Intervention / Treatment
Detailed Description
The overall objective of this study is to generate evidence for the efficacy of the PLAYshop program in diverse and vulnerable populations, such as families of lower socioeconomic status, who have been disproportionally affected by the COVID-19 Pandemic.
Research Questions:
Primary: Among vulnerable families (e.g., lower socioeconomic status), does the PLAYshop program increase parental capability, opportunity, and motivation to support preschool-aged children's physical literacy development, compared to controls? Secondary: What is the level of, and factors that influence, implementation at the family and program delivery level when working with vulnerable families? Tertiary: Does the PLAYshop program increase preschool-aged children's motivation and enjoyment, compared to controls?
Hypothesis for the primary research question: Increases in parental outcomes, including capability, opportunity, and motivation, will be greater in the intervention group, compared to the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2H9
- Faculty of Kinesiology, Sport, and Recreation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Parents of children aged 3 to 5 years who live in the provinces of Alberta and British Columbia and meet at least one of the following criteria:
- Statistics Canada's low income before tax cut-off based on household size and the population of the municipality they live in
- have an education level below a bachelor's degree (participating parent)
- are unemployed (participating parent)
- are a single adult in their household
- are connected with an agency partner that supports vulnerable populations
- Research staff and any organization partners who lead the workshop
Exclusion Criteria:
1) Parents:
- who do not have internet access to complete the questionnaires and join the virtual workshop. This includes access to a device such as a smartphone, tablet, or laptop/computer and a data plan or WIFI.
- who are not comfortable reading, writing, speaking and listening to at least one the following languages: English, Spanish, Farsi, Mandarin (Simplified Chinese), or Cantonese (Traditional Chinese).
- 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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PLAYshop Intervention
Participants will receive a 60 minute virtual/hybrid 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.
|
The intervention includes: 1. Educational Training - the 60 min virtual/hybrid 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 provided with 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.
|
No Intervention: Control
Participants will receive the 60 minute virtual/hybrid physical literacy workshop, equipment goody-bag, and access to the digital app after completing the follow-up measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in parents' capability to support preschool-aged children's physical literacy development
Time Frame: Baseline (all), immediately after workshop (intervention), one week after baseline (control)
|
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.
|
Baseline (all), immediately after workshop (intervention), one week after baseline (control)
|
Change in parents' opportunity to support preschool-aged children's physical literacy development
Time Frame: Baseline (all), immediately after workshop (intervention), one week after baseline (control)
|
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
|
Baseline (all), immediately after workshop (intervention), one week after baseline (control)
|
Change in parents' motivation to support preschool-aged children's physical literacy development
Time Frame: Baseline (all), immediately after workshop (intervention), one week after baseline (control)
|
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.
|
Baseline (all), immediately after workshop (intervention), one week after baseline (control)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implementation: satisfaction and perceived usefulness (questionnaire)
Time Frame: Intervention group: Immediately after the workshop
|
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.
|
Intervention group: Immediately after the workshop
|
Implementation: satisfaction and perceived usefulness (parental interview)
Time Frame: Intervention group: 2-month follow-up
|
Satisfaction and perceived usefulness of the intervention will also be explored via brief semi-structured interviews with parents from the intervention group.
|
Intervention group: 2-month follow-up
|
Implementation: facilitators and barriers (parental interview)
Time Frame: Intervention group: 2-month follow-up
|
Implementation facilitators and barriers will be explored via brief semi-structured interviews with parents from the intervention group.
|
Intervention group: 2-month follow-up
|
Implementation: facilitators and barriers (workshop leader interview)
Time Frame: At study completion, approximately 1 year from first workshop.
|
Implementation facilitators and barriers will be explored via brief semi-structured interviews with workshop leaders.
|
At study completion, approximately 1 year from first workshop.
|
Implementation: dose (parental interview)
Time Frame: Intervention group: 2-month follow-up
|
The dose of the intervention will be explored via brief semi-structured interviews with parents from the intervention group.
|
Intervention group: 2-month follow-up
|
Implementation: dose (app check-in questions)
Time Frame: Intervention group: Bi-weekly after workshop (i.e., 1, 3, 5, and 7 weeks)
|
The dose of the intervention will be assessed via check-in questions as part of the booster lessons in the intervention group.
|
Intervention group: Bi-weekly after workshop (i.e., 1, 3, 5, and 7 weeks)
|
Implementation: dose (app usage data)
Time Frame: Intervention group: 2-month follow-up
|
The dose of the intervention will be assessed via tracking of app usage in the intervention group.
|
Intervention group: 2-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in children's motivation and enjoyment
Time Frame: Baseline (all), immediately after workshop (intervention), one week after baseline (control)
|
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)
|
Baseline (all), immediately after workshop (intervention), one week after baseline (control)
|
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
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PLAYshop Expansion
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.
Clinical Trials on Parent-Child Relations
-
Esteban Gómez MuzzioNot yet recruitingParent-Child Relations | Parenting | Parent-child Problem
-
The University of Hong KongCompletedParent-Child Relations | Child DevelopmentHong Kong
-
Government College University FaisalabadActive, not recruitingParent-Child RelationsPakistan
-
University of OttawaWithdrawnParent-Child RelationsCanada
-
National Taipei University of Nursing and Health...CompletedParent-Child Relations
-
University of LiegeActive, not recruitingParent-Child Relations | Child DevelopmentBelgium
-
McGill UniversitySave the Children; European Network of Foundations Children and Violence Evaluation... and other collaboratorsUnknown
-
University of CalgaryRecruitingParent-Child RelationsCanada
-
University of OttawaRecruitingParent-Child RelationsCanada
-
Universitätsklinikum Hamburg-EppendorfRecruitingParent-Child RelationsGermany
Clinical Trials on PLAYshop Program
-
University of AlbertaUniversity of Victoria; Women and Children's Health Research Institute (WCHRI)Active, not recruitingParent-Child Relations | Child Development | Motor ActivityCanada
-
University of AlbertaUniversity of VictoriaCompletedParent-Child Relations | Motor ActivityCanada
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
National Taiwan University HospitalCompleted
-
University of Maryland, BaltimoreNational Institute of Nursing Research (NINR)CompletedOsteoporosis | Health Behaviors
-
University of AlcalaRecruitingLateral EpicondylitisSpain
-
Massachusetts General HospitalRecruitingPancreatic Ductal AdenocarcinomaUnited States
-
University of CagliariSuspended
-
University of Kansas Medical CenterUnknownUpper Extremity Injuries | Elbow Injuries | Sprain Ulnar Collateral Ligament | Strain of Ulnar Collateral Ligament | Complete Tear Ulnar Collateral LigamentUnited States
-
Sunnybrook Health Sciences CentreToronto Rehabilitation InstituteCompleted