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

Primary Purpose

Physical Activity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CSPAP-T
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seattle Children's Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Wedge 1 includes Schools 1 and 2.

Wedge 2 includes Schools 3, 4, and 5.

Wedge 3 includes Schools 6, 7, and 8.

Arm Description

Outcomes

Primary Outcome Measures

Change in 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 7 day periods (x 24 hour wear) at each of the data collection timepoints (i.e., fall and spring of each school year).
Change in Internalizing and Externalizing Symptoms.
Mental health symptomatology will be measured using the Strengths and Difficulties Questionnaire (self-report version for 11-16 year olds), a brief behavioral screening questionnaire. Scores will be calculated for internalizing problems (emotional+peer symptoms, 10 items, scale 0-20) and externalizing problems (conduct+hyperactivity symptoms, 10 items, scale 0-20). 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 Outcome Measures

Resilient psychosocial functioning
Psychological aspects of adolescent resilience will be measured using the 21-item Adolescent Resilience Scale. This three-factor scale measures emotional regulation, positive future orientation, and novelty seeking. This will be asked in surveys digitally distributed to all students in the fall and spring of each school year.

Full Information

First Posted
April 28, 2022
Last Updated
January 26, 2023
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05382975
Brief Title
A Comprehensive Trauma-sensitive Approach to Physical Activity Promotion in Schools (CSPAP-T)
Acronym
CSPAP-T
Official Title
A Comprehensive Trauma-sensitive Approach to Physical Activity Promotion in Schools (CSPAP-T)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Assess how intervention exposure is associated with student (accelerometer-measured) PA Assess how intervention exposure is associated with student internalizing and externalizing symptoms and resilient psychosocial function functioning 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Schools will be randomized to start the intervention at different time points
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wedge 1 includes Schools 1 and 2.
Arm Type
Other
Arm Title
Wedge 2 includes Schools 3, 4, and 5.
Arm Type
Other
Arm Title
Wedge 3 includes Schools 6, 7, and 8.
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
CSPAP-T
Intervention Description
Trauma-adapted CSPAP delivery: Staffing support Trauma-sensitive professional development for teachers and staff Setting specific needs assessment and action planning
Primary Outcome Measure Information:
Title
Change in Physical Activity - Accelerometer measured.
Description
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 7 day periods (x 24 hour wear) at each of the data collection timepoints (i.e., fall and spring of each school year).
Time Frame
2 times per year (Fall, Spring) up to 3 years
Title
Change in Internalizing and Externalizing Symptoms.
Description
Mental health symptomatology will be measured using the Strengths and Difficulties Questionnaire (self-report version for 11-16 year olds), a brief behavioral screening questionnaire. Scores will be calculated for internalizing problems (emotional+peer symptoms, 10 items, scale 0-20) and externalizing problems (conduct+hyperactivity symptoms, 10 items, scale 0-20). 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.
Time Frame
2 times per year (Fall, Spring) up to 3 years
Secondary Outcome Measure Information:
Title
Resilient psychosocial functioning
Description
Psychological aspects of adolescent resilience will be measured using the 21-item Adolescent Resilience Scale. This three-factor scale measures emotional regulation, positive future orientation, and novelty seeking. This will be asked in surveys digitally distributed to all students in the fall and spring of each school year.
Time Frame
2 times per year (Fall, Spring) up to 3 years
Other Pre-specified Outcome Measures:
Title
School-level physical activity
Description
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 3 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.
Time Frame
2 times per year (Fall, Spring) up to 3 years
Title
School-level physical activity practices.
Description
School administrators will complete the Comprehensive School Physical Activity Program Questionnaire (CSPAP-Q) to measure school-level physical activity practices.
Time Frame
2 times per year (Fall, Spring) up to 3 years
Title
School level trauma-sensitive practices
Description
School administrators will complete the Trauma Responsive School Implementation Assessment to assess the implementation of trauma-sensitive practices at the school
Time Frame
2 times per year (Fall, Spring) up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kim Garrett, MPH
Phone
206-884-5074
Email
kim.garrett@seattlechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Pooja Tandon, MD
Phone
206-884-1130
Email
pooja.tandon@seattlechildrens.org
Facility Information:
Facility Name
Seattle Children's Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pooja S Tandon, MD
Email
pooja.tandon@seattlechildrens.org

12. IPD Sharing Statement

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

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