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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05890456
Other study ID # R324A190122
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 22, 2021
Est. completion date June 30, 2026

Study information

Verified date May 2023
Source Oregon Social Learning Center
Contact Abby Murphy
Phone 541-485-2711
Email abbym@oslc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date June 30, 2026
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 10 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Students with Involved Families and Teacher Program
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.
Services As Usual
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.

Locations

Country Name City State
United States Oregon Social Learning Center Eugene Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Social Learning Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Changes in Youth Emotional and Behavioral Outcomes from 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
Primary Mean Changes in Youth Emotional and Behavioral Outcomes from 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
Primary Mean Changes in Youth Academic Outcomes from 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
Primary Mean Changes in Youth Academic Outcomes from 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
Primary Mean Changes in Parenting Outcomes from 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 Stability in School Placement from Baseline to 6 Months Measured by number of school placement moves. Measured at Baseline and 6 months post-Baseline. Baseline to 6 Months Post-Baseline
Secondary Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 12 Months Emotion regulation skills measured by the Emotion Regulation Checklist. Measured at Baseline and 12 months post-Baseline. Baseline to 12 Months Post-Baseline
Secondary Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 12 Months Psychopathological behaviors measured by the Child Behavior Checklist. Measured at Baseline and 12 months post-Baseline. Baseline to 12 Months Post-Baseline
Secondary Mean Changes in Youth Academic Outcomes from 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
Secondary Mean Changes in Youth Academic Outcomes from 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
Secondary Mean Changes in Parenting Outcomes from 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
Secondary Stability in School Placement from Baseline to 12 Months Measured by number of school placement moves. Measured at Baseline and 12 months post-Baseline. Baseline to 12 Months Post-Baseline
Secondary Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 18 Months Psychopathological behaviors measured by the Child Behavior Checklist. Measured at Baseline and 18 months post-Baseline. Baseline to 18 Months Post-Baseline
Secondary Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 18 Months Emotion regulation skills measured by the Emotion Regulation Checklist. Measured at Baseline and 18 months post-Baseline. Baseline to 18 Months Post-Baseline
Secondary Mean Changes in Youth Academic Outcomes from 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
Secondary Mean Changes in Youth Academic Outcomes from 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
Secondary Mean Changes in Parenting Outcomes from 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
Secondary Stability in School Placement from Baseline to 18 Months Measured by number of school placement moves. Measured at Baseline and 18 months post-Baseline. Baseline to 18 Months Post-Baseline
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