Clinical trial NCT05382975: A Comprehensive Trauma-sensitive Approach to Physical Activity Promotion in Schools (CSPAP-T)
Official title: A Comprehensive Trauma-sensitive Approach to Physical Activity Promotion in Schools (CSPAP-T)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Activity
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 8000
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Schools will be randomized to start the intervention at different time points
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Activity - Accelerometer measured.
timeFrame: 2 times per year (Fall, Spring) up to 3 years
measure: Change in Internalizing and Externalizing Symptoms.
timeFrame: 2 times per year (Fall, Spring) up to 3 years
Secondary outcomes:
measure: Resilient psychosocial functioning
timeFrame: 2 times per year (Fall, Spring) up to 3 years
Other outcomes:
measure: School-level physical activity
timeFrame: 2 times per year (Fall, Spring) up to 3 years
measure: School-level physical activity practices.
timeFrame: 2 times per year (Fall, Spring) up to 3 years
measure: School level trauma-sensitive practices
timeFrame: 2 times per year (Fall, Spring) up to 3 years
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
References: