- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05890456
Students With Involved Families and Teachers (SWIFT-RCT)
Efficacy of the Students With Involved Families and Teachers (SWIFT) Program for Students With Emotional and Behavioral Disorders
PURPOSE: In the proposed project, the investigators seek to examine whether the SWIFT Program might be efficacious to improve students' prosocial skills and emotion and behavior regulation and improve home-school communication and the use of positive parenting practices for families. The investigators will also test whether the SWIFT program might be efficacious to improve students' longer-term school adjustment and parents' involvement in school.
SETTING: Study activities will take place in ten school districts in Lane County, OR. The districts have approximately 10,000 middle school students (Grades 6-8), and approximately 60% of students are eligible for free and reduced price lunch. Some participating districts participated in the IES-funded Goal 2 study to develop the SWIFT Program.
POPULATION: 320 students in Grades 6-8 who are receiving special education services for emotional or behavioral disorders, and transitioning or at risk of transitioning between school settings and placements will be recruited. Parents and content area teachers of all participating students will be recruited to complete assessment measures. It is expected that up to 15% of the children in the study will be of Latino ethnicity and approximately 60% will be European-American and 10-20% will be of other or multiple ethnicities.
INTERVENTION: The SWIFT Program is a 9-12 month intervention that includes four components: (a) behavioral progress monitoring, (b) case management of the intervention elements and coordination with the school, (c) parent support to promote parent engagement/collaboration with the school and study routines in the home, and (d) behavioral skills coaching for students.
SERVICES AS USUAL (SAU) CONTROL CONDITION: The SAU students and families will continue to receive any services that they were receiving prior to their entry into the study (as will the SWIFT students and families). These may include school-based interventions and supports and related services as required in the student's IEP.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Courtenay Padgett
- Phone Number: 1332 541-485-2711
- Email: courtp@oslc.org
Study Contact Backup
- Name: Abby Murphy
- Phone Number: 1115 541-485-2711
- Email: abbym@oslc.org
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Recruiting
- Oregon Social Learning Center
-
Contact:
- Ted Donahue
- Phone Number: 1178 541-485-2711
- Email: tedd@oslc.org
-
Contact:
- Julie Stubbs
- Phone Number: 1322 541-485-2711
- Email: julies@oslc.org
-
Principal Investigator:
- Rohanna Buchanan, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students in grades 5 through 8
- In school districts in the the Lane Education Service District
- Eligible for or at risk of eligibility for special education services for emotional or behavior disorders
- Transitioning or at risk of transitioning between school settings or placements
- English or Spanish speaking
Exclusion Criteria:
- Students receiving intensive family and school support services from local community mental health agencies
- Students with a hearing or vision impairment that would limit participation in the program components or the assessment protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Arm
The SWIFT Program is a 9-12 month intervention that includes four components: (a) behavioral progress monitoring, (b) clinical supervision of the intervention elements and coordination with the school, (c) parent support to promote parent engagement/collaboration with the school and study routines in the home, and (d) behavioral skills coaching for students.
SWIFT students will continue to receive any school-based services that were receiving prior to entering the study.
|
The SWIFT Program is a 9-12 month intervention that includes four components: (a) behavioral progress monitoring, (b) clinical supervision of the intervention elements and coordination with the school, (c) parent support to promote parent engagement/collaboration with the school and study routines in the home, and (d) behavioral skills coaching for students.
Other Names:
|
|
Active Comparator: Services As Usual Control
The SAU students and families will continue to receive any services that they were receiving prior to their entry into the study.
These may include school-based interventions and supports and related services as required in the student's Individualized Education Program.
|
The SAU students and families will continue to receive any services that they were receiving prior to their entry into the study.
These may include school-based interventions and supports and related services as required in the student's Individualized Education Program.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 6 Months Post-Baseline
Time Frame: Baseline to 6 Months Post-Baseline
|
Emotion regulation skills measured by the Emotion Regulation Checklist.
Measured at Baseline and 6 months post-Baseline.
|
Baseline to 6 Months Post-Baseline
|
|
Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 6 Months Post-Baseline
Time Frame: Baseline to 6 Months Post-Baseline
|
Psychopathological behaviors measured by the Child Behavior Checklist.
Measured at Baseline and 6 months post-Baseline.
|
Baseline to 6 Months Post-Baseline
|
|
Mean Changes in Youth Academic Outcomes from Baseline to 6 Months Post-Baseline
Time Frame: Baseline to 6 Months Post-Baseline
|
Academic outcomes measured by youth grades.
Measured at Baseline and 6 months post-Baseline.
|
Baseline to 6 Months Post-Baseline
|
|
Mean Changes in Youth Academic Outcomes from Baseline to 6 Months Post-Baseline
Time Frame: Baseline to 6 Months Post-Baseline
|
Academic outcomes measured by EasyCBM score.
Measured at Baseline and 6 months post-Baseline.
|
Baseline to 6 Months Post-Baseline
|
|
Mean Changes in Parenting Outcomes from Baseline to 6 Months Post-Baseline
Time Frame: Baseline to 6 Months Post-Baseline
|
Parenting outcomes measured by the Parenting Practices Questionnaire.
Measured at Baseline and 6 months post-Baseline.
|
Baseline to 6 Months Post-Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stability in School Placement from Baseline to 6 Months
Time Frame: Baseline to 6 Months Post-Baseline
|
Measured by number of school placement moves.
Measured at Baseline and 6 months post-Baseline.
|
Baseline to 6 Months Post-Baseline
|
|
Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 12 Months
Time Frame: Baseline to 12 Months Post-Baseline
|
Emotion regulation skills measured by the Emotion Regulation Checklist.
Measured at Baseline and 12 months post-Baseline.
|
Baseline to 12 Months Post-Baseline
|
|
Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 12 Months
Time Frame: Baseline to 12 Months Post-Baseline
|
Psychopathological behaviors measured by the Child Behavior Checklist.
Measured at Baseline and 12 months post-Baseline.
|
Baseline to 12 Months Post-Baseline
|
|
Mean Changes in Youth Academic Outcomes from Baseline to 12 Months Post-Baseline
Time Frame: Baseline to 12 Months Post-Baseline
|
Academic outcomes measured by youth grades.
Measured at Baseline and 12 months post-Baseline.
|
Baseline to 12 Months Post-Baseline
|
|
Mean Changes in Youth Academic Outcomes from Baseline to 12 Months Post-Baseline
Time Frame: Baseline to 12 Months Post-Baseline
|
Academic outcomes measured by EasyCBM score.
Measured at Baseline and 12 months post-Baseline.
|
Baseline to 12 Months Post-Baseline
|
|
Mean Changes in Parenting Outcomes from Baseline to 12 Months Post-Baseline
Time Frame: Baseline to 12 Months Post-Baseline
|
Parenting outcomes measured by the Parenting Practices Questionnaire.
Measured at Baseline and 12 months post-Baseline.
|
Baseline to 12 Months Post-Baseline
|
|
Stability in School Placement from Baseline to 12 Months
Time Frame: Baseline to 12 Months Post-Baseline
|
Measured by number of school placement moves.
Measured at Baseline and 12 months post-Baseline.
|
Baseline to 12 Months Post-Baseline
|
|
Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 18 Months
Time Frame: Baseline to 18 Months Post-Baseline
|
Psychopathological behaviors measured by the Child Behavior Checklist.
Measured at Baseline and 18 months post-Baseline.
|
Baseline to 18 Months Post-Baseline
|
|
Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 18 Months
Time Frame: Baseline to 18 Months Post-Baseline
|
Emotion regulation skills measured by the Emotion Regulation Checklist.
Measured at Baseline and 18 months post-Baseline.
|
Baseline to 18 Months Post-Baseline
|
|
Mean Changes in Youth Academic Outcomes from Baseline to 18 Months Post-Baseline
Time Frame: Baseline to 18 Months Post-Baseline
|
Academic outcomes measured by youth grades.
Measured at Baseline and 18 months post-Baseline.
|
Baseline to 18 Months Post-Baseline
|
|
Mean Changes in Youth Academic Outcomes from Baseline to 18 Months Post-Baseline
Time Frame: Baseline to 18 Months Post-Baseline
|
Academic outcomes measured by EasyCBM score.
Measured at Baseline and 18 months post-Baseline.
|
Baseline to 18 Months Post-Baseline
|
|
Mean Changes in Parenting Outcomes from Baseline to 18 Months Post-Baseline
Time Frame: Baseline to 18 Months Post-Baseline
|
Parenting outcomes measured by the Parenting Practices Questionnaire.
Measured at Baseline and 18 months post-Baseline.
|
Baseline to 18 Months Post-Baseline
|
|
Stability in School Placement from Baseline to 18 Months
Time Frame: Baseline to 18 Months Post-Baseline
|
Measured by number of school placement moves.
Measured at Baseline and 18 months post-Baseline.
|
Baseline to 18 Months Post-Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rohanna Buchanan, PhD, Oregon Social Learning Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R324A190122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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