Adapted Comprehensive School Physical Activity Program (CSPAP-T)

June 25, 2026 updated by: Pooja Tandon, Seattle Children's Hospital
Investigators will conduct a hybrid implementation-effectiveness trial of an adapted Comprehensive School Physical Activity Program (CSPAP) intervention. A clustered stepped wedge design will be used, with the duration of the trial being 3 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Assess how intervention exposure is associated with student (accelerometer-measured) PA
  2. Assess how intervention exposure is associated with student depression and anxiety
  3. Assess how intervention exposure is associated with change in PA opportunities at the school level
  4. Explore systems-level barriers and facilitators to successful intervention implementation and maintenance.

Study Type

Interventional

Enrollment (Actual)

5637

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98101
        • Seattle Children's Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Wedge 1 includes Schools 1 and 2.

Adapted CSPAP delivery:

  • Staffing support
  • Professional development for teachers and staff
  • Setting specific needs assessment and action planning
Other: Wedge 2 includes Schools 3, 4, and 5.

Adapted CSPAP delivery:

  • Staffing support
  • Professional development for teachers and staff
  • Setting specific needs assessment and action planning
Other: Wedge 3 includes Schools 6 and 7.

Adapted CSPAP delivery:

  • Staffing support
  • Professional development for teachers and staff
  • Setting specific needs assessment and action planning

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).
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.
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.
2 times per year (Fall, Spring) up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 19, 2022

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

April 1, 2026

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

No

Studies a U.S. FDA-regulated device product

No

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.

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