Adapted Comprehensive School Physical Activity Program

NCT05382975 | Completed

• 1 other identifier: STUDY00003419
• Study Type: interventional
• Target: 5,637
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (2)

• Physical Activity - Accelerometer measured.

  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

  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 Outcomes (1)

• Resilient psychosocial functioning

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

Other Outcomes (1)

• School-level physical activity

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

Study Arms (3)

Wedge 1 includes Schools 1 and 2.

OTHER

Behavioral: CSPAP

Wedge 2 includes Schools 3, 4, and 5.

OTHER

Behavioral: CSPAP

Wedge 3 includes Schools 6 and 7.

OTHER

Behavioral: CSPAP

Interventions

CSPAP BEHAVIORAL

Adapted CSPAP delivery: * Staffing support * Professional development for teachers and staff * Setting specific needs assessment and action planning

Wedge 1 includes Schools 1 and 2.; Wedge 2 includes Schools 3, 4, and 5.; Wedge 3 includes Schools 6 and 7.

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 11-14 (inclusive)
• Attend one of the participating schools during the study period
• Age 18 or older
• Work at one of the participating schools during the study period

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Schools will be randomized to start the intervention at different time points

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 19, 2022
• Study Start: August 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 30, 2026

Record last verified: 2026-04

Locations

US (1)