Motor ActivityNCT05436197
The Expansion of a Parent-focused Physical Literacy Intervention for Early Childhood Called PLAYshop
A study testing PLAYshop Program in people with Motor Activity and Parent-Child Relations, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity, Parent-Child Relations, Child Development
- What is being tested?
- PLAYshop Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jul 2022to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Faculty of Kinesiology, Sport, and Recreation
Edmonton, Alberta, T6G 2H9
About this study
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?
Read the 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.
- Conditions
- Motor Activity, Parent-Child Relations, Child Development
- Being tested
- PLAYshop Program
- Keywords
- Questionnaires, Semi-structured Interviews
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAYshop ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PLAYshop Intervention | Experimental | 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. Receives: Behavioral: PLAYshop Program |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in parents' capability to support preschool-aged children's physical literacy development
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.
Measured: Baseline (all), immediately after workshop (intervention), one week after baseline (control)
Change in parents' opportunity to support preschool-aged children's physical literacy development
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
Measured: Baseline (all), immediately after workshop (intervention), one week after baseline (control)
Change in parents' motivation to support preschool-aged children's physical literacy development
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.
Measured: Baseline (all), immediately after workshop (intervention), one week after baseline (control)
Secondary outcomes (7)
Implementation: satisfaction and perceived usefulness (questionnaire)
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.
Measured: Intervention group: Immediately after the workshop
Implementation: satisfaction and perceived usefulness (parental interview)
Satisfaction and perceived usefulness of the intervention will also be explored via brief semi-structured interviews with parents from the intervention group.
Measured: Intervention group: 2-month follow-up
Implementation: facilitators and barriers (parental interview)
Implementation facilitators and barriers will be explored via brief semi-structured interviews with parents from the intervention group.
Measured: Intervention group: 2-month follow-up
Implementation: facilitators and barriers (workshop leader interview)
Implementation facilitators and barriers will be explored via brief semi-structured interviews with workshop leaders.
Measured: At study completion, approximately 1 year from first workshop.
Implementation: dose (parental interview)
The dose of the intervention will be explored via brief semi-structured interviews with parents from the intervention group.
Measured: Intervention group: 2-month follow-up
Implementation: dose (app check-in questions)
The dose of the intervention will be assessed via check-in questions as part of the booster lessons in the intervention group.
Measured: Intervention group: Bi-weekly after workshop (i.e., 1, 3, 5, and 7 weeks)
Implementation: dose (app usage data)
The dose of the intervention will be assessed via tracking of app usage in the intervention group.
Measured: Intervention group: 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start18 Jul 2022
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will complete the baseline measure and then be randomly assigned to group 1 (intervention) or group 2 (control), in a computer generated 1:1 sequence.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Victoria, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Valerie Carson, PhD, Principal investigator, University of AlbertaPatti-Jean Naylor, PhD, Principal investigator, University of VictoriaRyan Rhodes, PhD, Principal investigator, University of VictoriaSam Liu, PhD, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436197
- Sponsor's protocol ID
- PLAYshop Expansion
- Status last verified
- Dec 2024
- First submitted
- 23 Jun 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant's personal data, IPD will not be shared with researchers outside of the research team.
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.
PubMed 16490241Cairney 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.
PubMed 29930933Carson V, Potter M, Hwang Y, Buckler EJ, Boyd M, Rhodes RE, Liu S, Naylor PJ. The Expansion of a Parent-Focused Physical Literacy Intervention for Early Childhood to Families Experiencing Vulnerability: Randomized Controlled Trial. Res Q Exerc Sport. 2026 Aug 14:1-12. doi: 10.1080/02701367.2026.2714832. Online ahead of print.
PubMed 42599509
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expansion of a Parent-focused Physical Literacy Intervention for Early Childhood Called PLAYshop
- ClinicalTrials.gov ID
- NCT05436197
- Acronym / sponsor ID
- PLAYshop Expansion
- Conditions
- Motor Activity, Parent-Child Relations, Child Development
- Keywords
- Questionnaires, Semi-structured Interviews
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Victoria, Canadian Institutes of Health Research (CIHR)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will complete the baseline measure and then be randomly assigned to group 1 (intervention) or group 2 (control), in a computer generated 1:1 sequence.
| Arm | Type | Receives |
|---|---|---|
| PLAYshop Intervention | Experimental | Behavioral: PLAYshop ProgramParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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:
- Research staff and any organization partners who lead the workshop
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLAYshop ProgramThe 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. | Behavioural | PLAYshop Intervention |
Primary outcome
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.
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
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.
7 secondary outcomes
Implementation: satisfaction and perceived usefulness (questionnaire)
Time frame: Intervention group: Immediately after the workshop
Implementation: satisfaction and perceived usefulness (parental interview)
Time frame: Intervention group: 2-month follow-up
Implementation: facilitators and barriers (parental interview)
Time frame: 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: dose (parental interview)
Time frame: 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)
Implementation: dose (app usage data)
Time frame: Intervention group: 2-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 16490241Heitzler 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.
- Background: PubMed 29930933Cairney 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.
- Derived from this study: PubMed 42599509Carson V, Potter M, Hwang Y, Buckler EJ, Boyd M, Rhodes RE, Liu S, Naylor PJ. The Expansion of a Parent-Focused Physical Literacy Intervention for Early Childhood to Families Experiencing Vulnerability: Randomized Controlled Trial. Res Q Exerc Sport. 2026 Aug 14:1-12. doi: 10.1080/02701367.2026.2714832. Online ahead of print.
- Individual participant dataSharing planned: No. To protect participant's personal data, IPD will not be shared with researchers outside of the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Carson, PhD principal investigator
University of Alberta
Patti-Jean Naylor, PhD principal investigator
University of Victoria
Ryan Rhodes, PhD principal investigator
University of Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLAYshop Program in people with Motor Activity and Parent-Child Relations, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05436197, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.