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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05436197
Other study ID # PLAYshop Expansion
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 18, 2022
Est. completion date December 30, 2024

Study information

Verified date March 2024
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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?


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 32
Est. completion date December 30, 2024
Est. primary completion date February 6, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: 1. 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 2. 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PLAYshop Program
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.

Locations

Country Name City State
Canada Faculty of Kinesiology, Sport, and Recreation Edmonton Alberta

Sponsors (3)

Lead Sponsor Collaborator
University of Alberta Canadian Institutes of Health Research (CIHR), University of Victoria

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in children's motivation and enjoyment 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)
Primary 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. Baseline (all), immediately after workshop (intervention), one week after baseline (control)
Primary 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 Baseline (all), immediately after workshop (intervention), one week after baseline (control)
Primary 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. Baseline (all), immediately after workshop (intervention), one week after baseline (control)
Secondary 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. Intervention group: Immediately after the workshop
Secondary 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. Intervention group: 2-month follow-up
Secondary Implementation: facilitators and barriers (parental interview) Implementation facilitators and barriers will be explored via brief semi-structured interviews with parents from the intervention group. Intervention group: 2-month follow-up
Secondary Implementation: facilitators and barriers (workshop leader interview) Implementation facilitators and barriers will be explored via brief semi-structured interviews with workshop leaders. At study completion, approximately 1 year from first workshop.
Secondary Implementation: dose (parental interview) 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
Secondary 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. Intervention group: Bi-weekly after workshop (i.e., 1, 3, 5, and 7 weeks)
Secondary Implementation: dose (app usage data) The dose of the intervention will be assessed via tracking of app usage in the intervention group. Intervention group: 2-month follow-up
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