Emotional RegulationSWIFT-RCTNCT05890456
Students With Involved Families and Teachers
A study testing Students with Involved Families and Teacher Program and Services As Usual in people with Emotional Regulation and Adolescent Behavior, run by Oregon Social Learning Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Emotional Regulation, Adolescent Behavior, Parenting
- What is being tested?
- Students with Involved Families and Teacher Program and Services As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Social Learning Center
Eugene, Oregon, 97401
Ted Donahue, 541-485-2711 ext. 1178, tedd@oslc.org
Julie Stubbs, 541-485-2711 ext. 1322, julies@oslc.org
About this study
Official title: 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.
Read more
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.
- Conditions
- Emotional Regulation, Adolescent Behavior, Parenting
- Being tested
- Students with Involved Families and Teacher Program, Services As Usual
- Keywords
- Positive Parenting, Behavior Regulation, Academic Success
- Medical subject headings
- Emotional Regulation, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Students with Involved Families and Teacher ProgramBehavioural
Also called SWIFT
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 UsualBehavioural
Also called SAU
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Services As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 Months Post-Baseline
Secondary outcomes (13)
Stability in School Placement from Baseline to 6 Months
Measured by number of school placement moves. Measured at Baseline and 6 months post-Baseline.
Measured: Baseline to 6 Months Post-Baseline
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.
Measured: Baseline to 12 Months Post-Baseline
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.
Measured: Baseline to 12 Months Post-Baseline
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.
Measured: Baseline to 12 Months Post-Baseline
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.
Measured: Baseline to 12 Months Post-Baseline
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.
Measured: Baseline to 12 Months Post-Baseline
Stability in School Placement from Baseline to 12 Months
Measured by number of school placement moves. Measured at Baseline and 12 months post-Baseline.
Measured: Baseline to 12 Months Post-Baseline
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.
Measured: Baseline to 18 Months Post-Baseline
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.
Measured: Baseline to 18 Months Post-Baseline
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.
Measured: Baseline to 18 Months Post-Baseline
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.
Measured: Baseline to 18 Months Post-Baseline
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.
Measured: Baseline to 18 Months Post-Baseline
Stability in School Placement from Baseline to 18 Months
Measured by number of school placement moves. Measured at Baseline and 18 months post-Baseline.
Measured: Baseline to 18 Months Post-Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start22 Dec 2021
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohanna Buchanan, Oregon Social Learning Center
- Investigators
- Rohanna Buchanan, PhD, Principal investigator, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890456
- Sponsor's protocol ID
- R324A190122
- Acronym
- SWIFT-RCT
- Status last verified
- May 2023
- First submitted
- 22 Feb 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Per IES requirements...
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Students With Involved Families and Teachers (SWIFT) Program for Students With Emotional and Behavioral Disorders
- ClinicalTrials.gov ID
- NCT05890456
- Acronym / sponsor ID
- SWIFT-RCT / R324A190122
- Conditions
- Emotional Regulation, Adolescent Behavior, Parenting
- Keywords
- Positive Parenting, Behavior Regulation, Academic Success
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Behavioral: Students with Involved Families and Teacher ProgramThe 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. |
| Services As Usual Control | Active comparator | Behavioral: Services As UsualThe 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Students with Involved Families and Teacher ProgramAlso: SWIFTThe 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. | Behavioural | Treatment Arm |
| Services As UsualAlso: SAUThe 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. | Behavioural | Services As Usual Control |
Primary outcome
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.
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.
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.
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.
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.
13 secondary outcomes
Stability in School Placement from Baseline to 6 Months
Time frame: 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
Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 12 Months
Time frame: 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
Mean Changes in Youth Academic Outcomes from Baseline to 12 Months Post-Baseline
Time frame: 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
Stability in School Placement from Baseline to 12 Months
Time frame: 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
Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 18 Months
Time frame: 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
Mean Changes in Youth Academic Outcomes from Baseline to 18 Months Post-Baseline
Time frame: 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
Stability in School Placement from Baseline to 18 Months
Time frame: Baseline to 18 Months Post-Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: Yes. Per IES requirements...
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohanna Buchanan, PhD principal investigator
Oregon Social Learning Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Students with Involved Families and Teacher Program and Services As Usual in people with Emotional Regulation and Adolescent Behavior, run by Oregon Social Learning Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abby Murphy (541-485-2711 ext. 1115, abbym@oslc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 6 Months Post-Baseline (time frame: Baseline to 6 Months Post-Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.