Emotional DisturbancePhase 1OnTrackNCT01705431
Students, Parents, and Teachers On Track: Intervention Development for Youth With Emotional Disturbance
A Phase 1 study testing On Track in people with Emotional Disturbance, run by Oregon Social Learning Center at 1 site in United States.
Trial summary
The purpose of the On Track intervention is to address a need raised by a day-treatment school in Lane County: Support for students transitioning from the day-treatment school (Lane School) to their district middle schools. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Emotional Disturbance
- What is being tested?
- On Track
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Nov 2015
- Phase
- Phase 1
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical Diagnosis of Emotional and Behavioral Disturbance
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the On Track intervention is to address a need raised by a day-treatment school in Lane County: Support for students transitioning from the day-treatment school (Lane School) to their district middle schools. Eligible students are currently attending Lane School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are preparing to transition to their district schools.
Read the detailed description
A significant problem in education is that the transition period between a treatment school and a district school represents a high-risk time for failure. Education service district and school district leadership in Lane County contacted the Oregon Social Learning Center to collaborate on this project stating that during this transition period the students have insufficient strategies, services, and supports for generalizing the gains made at Lane School (the treatment school) back into the district middle school setting. They reported that this is a period of high stress and instability for many students and their families. Additionally, district schools lack the resources and supports to import the strategies that supported students to be successful at Lane School. Lane School works to track students' placement and services following completion of their program and data indicate that in the first year after transition, approximately 82% of middle school students transfer to public schools in their home district and the remaining students transfer directly to alternative or in-patient treatment centers. By the second year after transition, however, the majority of students who attended public schools were placed in self-contained classrooms, alternative placements, treatment centers, or received out-of-school tutoring due to emotional and behavioral problems. In addition, many students have high rates of truancy and low levels of parental support. This project is intended to address the gaps in support to increase placement stability at the district schools following the transition. To date, four students have begun the transition process with support from this project. One student has fully transitioned and results from qualitative interviews with the parent and the teacher indicate that the intervention is well liked and providing the supports needed to promote student success at the district middle school. We will continue to collect data to determine the level impact in this domain. A secondary impact is developing strategies to effectively collaborate with multiple school districts to support the common goal of transitioning students smoothly and sustaining placement stability. It is our goal to disseminate these strategies via publications and presentations with other educational researchers and practitioners.
- Conditions
- Emotional Disturbance
- Being tested
- On Track
- Keywords
- Emotional Disturbance, Behavioral Disturbance, EBD, Middle School, Special Education, School Psychology
- Medical subject headings
- Affective Symptoms, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On TrackBehavioural
Also called SWIFT
The purpose of the On Track intervention is to address a need raised by a day-treatment school in Lane County: Support for students transitioning from the day-treatment school (Lane School) to their district middle schools. Eligible students are currently attending Lane School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are preparing to transition to their district schools.
| Study group | Role | What they receive |
|---|---|---|
| Support for students with EBD | Experimental | Not described Receives: Behavioral: On Track |
| Control | No intervention | Participants continue with services as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful School Transition
Evidence of academic and social success in transition from treatment school to district school
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisturbanceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rohanna Buchanan, PhD, Principal investigator, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705431
- Sponsor's protocol ID
- IES R324A110370
- Acronym
- OnTrack
- Status last verified
- Dec 2015
- First submitted
- 9 Oct 2012
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Students, Parents, and Teachers On Track: Intervention Development for Youth With Emotional Disturbance
- ClinicalTrials.gov ID
- NCT01705431
- Acronym / sponsor ID
- OnTrack / IES R324A110370
- Conditions
- Emotional Disturbance
- Keywords
- Emotional Disturbance, Behavioral Disturbance, EBD, Middle School, Special Education, School Psychology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 12 Oct 2012 (estimated)
- 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.
The purpose of the On Track intervention is to address a need raised by a day-treatment school in Lane County: Support for students transitioning from the day-treatment school (Lane School) to their district middle schools. Eligible students are currently attending Lane School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are preparing to transition to their district schools.
Detailed description
A significant problem in education is that the transition period between a treatment school and a district school represents a high-risk time for failure. Education service district and school district leadership in Lane County contacted the Oregon Social Learning Center to collaborate on this project stating that during this transition period the students have insufficient strategies, services, and supports for generalizing the gains made at Lane School (the treatment school) back into the district middle school setting. They reported that this is a period of high stress and instability for many students and their families. Additionally, district schools lack the resources and supports to import the strategies that supported students to be successful at Lane School. Lane School works to track students' placement and services following completion of their program and data indicate that in the first year after transition, approximately 82% of middle school students transfer to public schools in their home district and the remaining students transfer directly to alternative or in-patient treatment centers. By the second year after transition, however, the majority of students who attended public schools were placed in self-contained classrooms, alternative placements, treatment centers, or received out-of-school tutoring due to emotional and behavioral problems. In addition, many students have high rates of truancy and low levels of parental support. This project is intended to address the gaps in support to increase placement stability at the district schools following the transition. To date, four students have begun the transition process with support from this project. One student has fully transitioned and results from qualitative interviews with the parent and the teacher indicate that the intervention is well liked and providing the supports needed to promote student success at the district middle school. We will continue to collect data to determine the level impact in this domain. A secondary impact is developing strategies to effectively collaborate with multiple school districts to support the common goal of transitioning students smoothly and sustaining placement stability. It is our goal to disseminate these strategies via publications and presentations with other educational researchers and practitioners.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Support for students with EBD | Experimental | Behavioral: On Track |
| Control | No intervention | –Participants continue with services as usual |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical Diagnosis of Emotional and Behavioral Disturbance
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| On TrackAlso: SWIFTThe purpose of the On Track intervention is to address a need raised by a day-treatment school in Lane County: Support for students transitioning from the day-treatment school (Lane School) to their district middle schools. Eligible students are currently attending Lane School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are preparing to transition to their district schools. | Behavioural | Support for students with EBD |
Primary outcome
Successful School Transition
Time frame: 12 months
Evidence of academic and social success in transition from treatment school to district school
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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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 Phase 1 study testing On Track in people with Emotional Disturbance, 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 14 Dec 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful School Transition (time frame: 12 months). 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 14 Dec 2015.