- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05382975
Adapted Comprehensive School Physical Activity Program (CSPAP-T)
Study Overview
Detailed Description
The Comprehensive School Physical Activity Program (CSPAP) is a multi-component approach by which schools use all opportunities for students to be physically active in 5 domains: physical education; physical activity during school; physical activity before and after school; staff involvement; and family and community engagement. Overall, CSPAP-based interventions have had small effect sizes in impacting youth PA, with larger effect sizes seen when more CSPAP domains are included. CSPAP-based interventions may be particularly beneficial for students attending schools located in communities with the fewest out of school resources for PA. There is thus a critical need to effectively support schools in increasing PA opportunities with an emphasis on meeting the PA-related needs of youth who have limited access to opportunities for physical activity, sports, and outdoor recreation.
The effectiveness and implementation of a flexible, systems-level intervention to increase opportunities for PA in middle schools will be studied. The intervention seeks to support middle schools in increasing opportunities for PA practices in all CSPAP domains-addressing two core systems-level barriers to such implementation (staffing and teacher/staff training) and building in flexibility for setting-specific needs assessment and action planning. Core components include (1) provision of a dedicated staff member (via Americorps or other organization) to support school PA (via direct staffing and capacity building), (2) setting-specific needs assessment and action planning, and (3) professional development opportunities for teachers, staff, and coaches related to the provision of PA across CSPAP domains.
The study will use a stepped wedge design with a total of 7 middle schools, in which each school will be randomized to start the intervention at different time points. All schools will provide baseline data and will later switch to the intervention phase in random order and in 3 waves. Based on feasibility considerations, 2 schools will switch from control phase to intervention phase in wedge 1, 3 schools will be in wedge 2, and 2 schools will be in wedge 3. Each 2-year intervention phase will be followed by a year when data will be collected to assess sustainability of the intervention. In total, there will be approximately 15 control phase data collections, 20 intervention phase data collections, for a total of 1800 student-assessments. This study will:
- Assess how intervention exposure is associated with student (accelerometer-measured) PA
- Assess how intervention exposure is associated with student depression and anxiety
- Assess how intervention exposure is associated with change in PA opportunities at the school level
- Explore systems-level barriers and facilitators to successful intervention implementation and maintenance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98101
- Seattle Children's Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Adolescent Inclusion Criteria:
- Age 11-14 (inclusive)
- Attend one of the participating schools during the study period
Teacher/Staff Inclusion Criteria:
- Age 18 or older
- Work at one of the participating schools during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Wedge 1 includes Schools 1 and 2.
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Adapted CSPAP delivery:
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Other: Wedge 2 includes Schools 3, 4, and 5.
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Adapted CSPAP delivery:
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Other: Wedge 3 includes Schools 6 and 7.
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Adapted CSPAP delivery:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity - Accelerometer measured.
Time Frame: 2 times per year (Fall, Spring) up to 3 years
|
This is the primary outcome for this study and will be collected from a gender stratified random subset of at least 45 students per school, at each time point.
Physical activity will be objectively measured using the ActiGraph GT3X worn at the hip for 5 day periods (x 10 hour wear) at each of the data collection timepoints (i.e., fall and spring of each school year).
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2 times per year (Fall, Spring) up to 3 years
|
|
Anxiety and Depression
Time Frame: 2 times per year (Fall, Spring) up to 3 years
|
Mental health symptomatology will be measured using the Patient Health Questionnaire for Depression and Anxiety (the PHQ-4), a brief behavioral screening questionnaire.
Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).
This will be asked in surveys digitally distributed to all students in the fall and spring of each school year.
Higher scores indicate worse outcomes.
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2 times per year (Fall, Spring) up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilient psychosocial functioning
Time Frame: 2 times per year (Fall, Spring) up to 3 years
|
Psychological aspects of adolescent resilience will be measured using the positive future orientation domain of the 21-item Adolescent Resilience Scale.
This will be asked in surveys digitally distributed to all students in the fall and spring of each school year.
|
2 times per year (Fall, Spring) up to 3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School-level physical activity
Time Frame: 2 times per year (Fall, Spring) up to 3 years
|
The SOPLAY (System of Observing Play and Leisure Activity in Youth) is a validated observation tool designed to obtain observational data on the number of students, their physical activity levels in a specified area (target area) where physical activity could occur, and the predominant type of activity.
Data collection will occur for 2 days at each time point, at each school during data collection periods (i.e., fall and spring of each school year) to assess proportion of children engaging in moderate to vigorous physical activity in the various target areas.
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2 times per year (Fall, Spring) up to 3 years
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Collaborators and Investigators
Sponsor
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003419
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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