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Behavioral Intervention
Trauma-Sensitive Physical Activity Program for Trauma Support (CSPAP-T Trial)
N/A
Recruiting
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Teacher/Staff: Age 18 or older
Adolescent: Age 11-14 (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 times per year (fall, spring) up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trialwill study how a physical activity program can help trauma survivors in schools. It will last 3 years and use a special design to measure effectiveness.
Who is the study for?
This trial is for kids aged 11-14 and adults over 18 who either attend or work at one of the participating schools. It's designed to help those with allergies and improve physical activity through a special program.
What is being tested?
The study tests a trauma-adapted school program called CSPAP-T, aimed at promoting physical activity in a way that's sensitive to students' emotional needs. The trial will unfold over three years using a stepped wedge design.
What are the potential side effects?
Since this intervention involves educational and physical activity programs rather than medication, traditional side effects are not applicable. However, participants may experience fatigue or muscle soreness from increased activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a teacher or staff member aged 18 or older.
Select...
I am between 11 and 14 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 times per year (fall, spring) up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 times per year (fall, spring) up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Internalizing and Externalizing Symptoms.
Change in Physical Activity - Accelerometer measured.
Secondary study objectives
Resilient psychosocial functioning
Other study objectives
School level trauma-sensitive practices
School-level physical activity
School-level physical activity practices.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Wedge 3 includes Schools 6, 7, and 8.Experimental Treatment1 Intervention
Group II: Wedge 2 includes Schools 3, 4, and 5.Experimental Treatment1 Intervention
Group III: Wedge 1 includes Schools 1 and 2.Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,223,580 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 11 and 14 years old.I am a teacher or staff member aged 18 or older.I am between 11 and 14 years old.You must be enrolled in one of the schools that is taking part in the study during the study period.You must be employed at one of the schools involved in the study during the study period.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Wedge 1 includes Schools 1 and 2.
- Group 2: Wedge 2 includes Schools 3, 4, and 5.
- Group 3: Wedge 3 includes Schools 6, 7, and 8.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.