A Comprehensive Trauma-sensitive Approach to Physical Activity Promotion in Schools (CSPAP-T)

NCT ID: NCT05382975

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-12-31

Brief Summary

Investigators will conduct a hybrid implementation-effectiveness trial of a trauma-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.

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 are the least effective, and have the most barriers to implementation and sustainability, in school districts that serve a student population that experience intersecting forms of disadvantage and discrimination. Core reasons for this include: (1) youth who have experienced trauma may have unique needs in PA settings, (2) Teachers/staff are not trained to meet the needs of youth who have experienced trauma in PA settings, and (3) staffing constrains the ability of schools to implement new opportunities for PA.

The effectiveness and implementation of a flexible, systems-level intervention to increase opportunities for trauma-sensitive PA in middle schools will be studied. The intervention seeks to support middle schools in increasing opportunities for trauma-sensitive 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) 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 trauma-sensitive PA.

The study will use a stepped wedge design with a total of 8 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 3 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 20 control phase data collections, 24 intervention phase data collections, and 16 data collections during maintenance phase, for a total of 1800 student-assessments (across all schools and all time periods for 20 control and 40 intervention or post-intervention periods). This study will:

1. Assess how intervention exposure is associated with student (accelerometer-measured) PA

2. Assess how intervention exposure is associated with student internalizing and externalizing symptoms and resilient psychosocial function functioning

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.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Wedge 1 includes Schools 1 and 2.

Group Type: OTHER

CSPAP-T

Intervention Type: BEHAVIORAL

Trauma-adapted CSPAP delivery:

• Staffing support
• Trauma-sensitive professional development for teachers and staff
• Setting specific needs assessment and action planning

Wedge 2 includes Schools 3, 4, and 5.

Group Type: OTHER

CSPAP-T

Intervention Type: BEHAVIORAL

Trauma-adapted CSPAP delivery:

• Staffing support
• Trauma-sensitive professional development for teachers and staff
• Setting specific needs assessment and action planning

Wedge 3 includes Schools 6, 7, and 8.

Group Type: OTHER

CSPAP-T

Intervention Type: BEHAVIORAL

Trauma-adapted CSPAP delivery:

• Staffing support
• Trauma-sensitive professional development for teachers and staff
• Setting specific needs assessment and action planning

Interventions

CSPAP-T

Trauma-adapted CSPAP delivery:

• Staffing support
• Trauma-sensitive professional development for teachers and staff
• Setting specific needs assessment and action planning

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pooja Tandon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seattle Children's Research Institute

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kim Garrett, MPH

Role: CONTACT

kim.garrett@seattlechildrens.org

206-884-5074

Pooja Tandon, MD

Role: CONTACT

pooja.tandon@seattlechildrens.org

206-884-1130

Facility Contacts

Pooja S Tandon, MD

Role: primary

pooja.tandon@seattlechildrens.org

Other Identifiers

STUDY00003419

Identifier Type: -

Identifier Source: org_study_id