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Completed

NCT Number: NCT05382975

Adapted Comprehensive School Physical Activity Program

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.

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Key information

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Research Institute

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CSPAP

Behavioral

Adapted CSPAP delivery:

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

Primary outcomes

  1. 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. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 19, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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