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

NCT05382975 | Recruiting

• 1 other identifier: STUDY00003419
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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.

  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 (3)

• School-level physical activity

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

• School-level physical activity practices.

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

• School level trauma-sensitive practices

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

Study Arms (3)

Wedge 1 includes Schools 1 and 2.

OTHER

Behavioral: CSPAP-T

Wedge 2 includes Schools 3, 4, and 5.

OTHER

Behavioral: CSPAP-T

Wedge 3 includes Schools 6, 7, and 8.

OTHER

Behavioral: CSPAP-T

Interventions

CSPAP-T BEHAVIORAL

Trauma-adapted CSPAP delivery: * Staffing support * Trauma-sensitive 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, 7, and 8.

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

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Kim Garrett, MPH

CONTACT

206-884-5074; kim.garrett@seattlechildrens.org

Pooja Tandon, MD

CONTACT

206-884-1130; pooja.tandon@seattlechildrens.org

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 (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

US (1)