Motor ActivityNCT05255250
PLAYshop: A Parent-focused Physical Literacy Intervention for Early Childhood
A study testing PLAYshop 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 designed to address this major public health issue of childhood physical inactivity and to support families. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 24 Feb 2022to 30 Aug 2023
- 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
- Children aged 3-5 years and their parents
- Living in non-rural areas of Alberta or British Columbia, Canada as defined by Statistics Canada
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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.
- Conditions
- Motor Activity, Parent-Child Relations, Child Development
- Being tested
- PLAYshop
- Keywords
- Questionnaires, Interviews, Fundamental movement skill assessments, Accelerometers
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLAYshopBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PLAYshop Intervention | Experimental | 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. Receives: Behavioral: PLAYshop |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in children's physical literacy (fundamental movement skills)
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).
Measured: Baseline and 2 month follow-up
Change in children's physical literacy (motivation and enjoyment; parental report)
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)
Measured: Baseline and 2 month follow-up
Change in children's physical literacy (enjoyment; child report)
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)
Measured: Baseline and 2 month follow-up
Secondary outcomes (4)
Change in children's physical activity
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.
Measured: Baseline and 2 month follow-up
Change in parent-child co-participation in physical activity (accelerometer)
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.
Measured: Baseline and 2 month follow-up
Change in parent-child co-participation in physical activity (questionnaire)
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
Measured: Baseline and 2 month follow-up
Change in parental physical activity modelling
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
Measured: Baseline and 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 posted24 Feb 2022
- Study start24 Feb 2022
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 baseline measures and then be randomly assigned to group 1 (intervention) or group 2 (control), in a computer generated1:1 sequence.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Victoria, Women and Children's Health Research Institute, Canada
- 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
- NCT05255250
- Sponsor's protocol ID
- PLAYshop2022
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 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
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.
PubMed 33148276Heitzler 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 16490241Hall, 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.
PubMed 29930933Davison 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.
PubMed 21111755Carson V, Boyd M, Potter M, Rhodes R, Liu S, Naylor PJ. Protocol for the PLAYshop randomised controlled trial: examining efficacy of a virtually delivered parent-focused physical literacy intervention for early childhood on child-specific and family-specific outcomes. BMJ Open. 2022 Dec 22;12(12):e066962. doi: 10.1136/bmjopen-2022-066962.
PubMed 36549741
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
- PLAYshop: A Parent-focused Physical Literacy Intervention for Early Childhood
- ClinicalTrials.gov ID
- NCT05255250
- Acronym / sponsor ID
- PLAYshop2022
- Conditions
- Motor Activity, Parent-Child Relations, Child Development
- Keywords
- Questionnaires, Interviews, Fundamental movement skill assessments, Accelerometers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Victoria, Women and Children's Health Research Institute, Canada
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 24 Feb 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 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?
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will complete baseline measures and then be randomly assigned to group 1 (intervention) or group 2 (control), in a computer generated1:1 sequence.
| Arm | Type | Receives |
|---|---|---|
| PLAYshop Intervention | Experimental | Behavioral: PLAYshopParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 3-5 years and their parents
- Living in non-rural areas of Alberta or British Columbia, Canada as defined by Statistics Canada
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| PLAYshopThe 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. | Behavioural | PLAYshop Intervention |
Primary outcome
Change in children's physical literacy (fundamental movement skills)
Time frame: Baseline and 2 month follow-up
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).
Change in children's physical literacy (motivation and enjoyment; parental report)
Time frame: Baseline and 2 month follow-up
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)
Change in children's physical literacy (enjoyment; child report)
Time frame: Baseline and 2 month follow-up
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)
4 secondary outcomes
Change in children's physical activity
Time frame: Baseline and 2 month follow-up
Change in parent-child co-participation in physical activity (accelerometer)
Time frame: Baseline and 2 month follow-up
Change in parent-child co-participation in physical activity (questionnaire)
Time frame: Baseline and 2 month follow-up
Change in parental physical activity modelling
Time frame: Baseline and 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 33148276Masse 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.
- 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.
- BackgroundHall, 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.
- 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.
- Background: PubMed 21111755Davison 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.
- Derived from this study: PubMed 36549741Carson V, Boyd M, Potter M, Rhodes R, Liu S, Naylor PJ. Protocol for the PLAYshop randomised controlled trial: examining efficacy of a virtually delivered parent-focused physical literacy intervention for early childhood on child-specific and family-specific outcomes. BMJ Open. 2022 Dec 22;12(12):e066962. doi: 10.1136/bmjopen-2022-066962.
- Individual participant dataSharing planned: No. To protect participant's personal data, IPD will not be shared with researchers outside of the research team.
Related trials for Motor Activity
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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 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 2 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 children's physical literacy (fundamental movement skills) (time frame: Baseline and 2 month follow-up). 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 NCT05255250, which also lists 6 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.