NCT05890456

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Dec 2021Jun 2026

Study Start

First participant enrolled

December 22, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

3.1 years

First QC Date

February 22, 2023

Last Update Submit

May 26, 2023

Conditions

Keywords

Positive ParentingBehavior RegulationAcademic Success

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (13)

  • Stability in School Placement from Baseline to 6 Months

    Baseline to 6 Months Post-Baseline

  • Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 12 Months

    Baseline to 12 Months Post-Baseline

  • Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 12 Months

    Baseline to 12 Months Post-Baseline

  • Mean Changes in Youth Academic Outcomes from Baseline to 12 Months Post-Baseline

    Baseline to 12 Months Post-Baseline

  • Mean Changes in Youth Academic Outcomes from Baseline to 12 Months Post-Baseline

    Baseline to 12 Months Post-Baseline

  • +8 more secondary outcomes

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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.

Behavioral: Students with Involved Families and Teacher Program

Services As Usual Control

ACTIVE COMPARATOR

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.

Behavioral: Services As Usual

Interventions

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.

Also known as: SWIFT
Treatment Arm

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.

Also known as: SAU
Services As Usual Control

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Social Learning Center

Eugene, Oregon, 97401, United States

RECRUITING

MeSH Terms

Conditions

Emotional RegulationAdolescent Behavior

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Rohanna Buchanan, PhD

    Oregon Social Learning Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abby Murphy

CONTACT

Courtenay Padgett

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Students and their families will be randomly assigned to the SWIFT Program or SAU conditions. A blocked design will be used where randomization will occur at the individual level within each school once a family has agreed to study participation. This way variation between schools (blocks) will not affect the standard errors of treatment effect estimates. Key outcomes will be tested at Time 1 (T1, baseline), Time 2 (T2, 6 months post-baseline), Time 3 (T3, 12 months post-baseline), and Time 4 (T4, 18 months post-baseline).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

February 22, 2023

First Posted

June 6, 2023

Study Start

December 22, 2021

Primary Completion

January 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

June 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Per IES requirements...

Locations