Autism Spectrum DisorderSTEPSNCT02468505
STEPS: Stepped Transition in Education Program for Students With ASD
A study testing STEPS in people with Autism Spectrum Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Young adults who have Autism Spectrum Disorder (ASD) without co-occurring intellectual impairment face a fairly unique set of challenges as they transition out of secondary school. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- STEPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 1 Oct 2018
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must be 16 to 25 years
- Must have clinical diagnosis of autism spectrum disorder
- Must be preparing for postsecondary education or enrolled in postsecondary education
Who cannot join
- Intellectual disability
- Psychiatric disturbance that warrants immediate treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24061
About this study
Young adults who have Autism Spectrum Disorder (ASD) without co-occurring intellectual impairment face a fairly unique set of challenges as they transition out of secondary school. These students are often quite capable of succeeding in higher education and many of them have interest in pursuing advanced degrees, but the nature of their disability and associated deficits (e.g., poor time management and poor self-regulation) may impede success. Individualized, appropriately timed, and developmentally sensitive transition and support services may promote optimal outcomes for these young people. The goal of this project is to develop a comprehensive program to promote successful transition of students with ASD from high school to post-secondary education.
Read the detailed description
The investigators propose to refine and then evaluate a novel transition support and intervention program for adolescents and young adults with ASD: STEPS [Stepped Transition in Education Program for Students with ASD]. By targeting improved self-regulation (SR) and self-determination (SD) in young people with ASD, the investigators assert that this program may have positive outcomes with respective to college adjustment and functional behavior. Although the program will be finalized during the first phase of the proposed project, at present STEPS is comprised of two levels (or steps), which match the student's particular needs in relation to transition planning. In Step 1, students facing transition (i.e., have identified the college they will attend (either 2-year or 4-year institution) but are still in high school) and their caregivers will receive information to assist in transition planning, undergo readiness self-assessments (to identify degree of preparedness for post-secondary school), and participate in interactive sessions online and in person to promote self-knowledge and determination. The goal of Step 1 is to assist families and students with transition planning, specifically ensuring that families and students have the tools needed to make informed choices and take necessary steps (e.g., remediating identified skill deficits) to increase the likelihood of a successful transition out of high school. In Step 2, college students with ASD will receive fairly intensive supports and interventions, including individual counseling, structured support services, social integration activities, and coaching to promote academic and social success. The following specific aims are proposed.
- Conditions
- Autism Spectrum Disorder
- Being tested
- STEPS
- Keywords
- Structured transition support program, Transition 'as usual'
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPSBehavioural
time-limited behavioral counseling, online materials, training
| Study group | Role | What they receive |
|---|---|---|
| STEPS | Experimental | structured psychosocial transition support that includes individual counseling, and education/training for parent and school personnel Receives: Behavioral: STEPS |
| TAU | No intervention | typical transition services and supports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire to measure feasibility and program acceptability
parent- and youth self-report measure of utility of program, acceptability, and consumer satisfaction
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startSep 2014
- Primary completion1 Jul 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Principal investigator, Yasuo Miyazaki, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468505
- Sponsor's protocol ID
- R34MH104337
- Acronym
- STEPS
- Status last verified
- Jul 2019
- First submitted
- 4 Jun 2015
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEPS: Stepped Transition in Education Program for Students With ASD
- ClinicalTrials.gov ID
- NCT02468505
- Acronym / sponsor ID
- STEPS / R34MH104337
- Conditions
- Autism Spectrum Disorder
- Keywords
- Structured transition support program, Transition 'as usual'
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Sep 2014
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 11 Jun 2015 (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.
Young adults who have Autism Spectrum Disorder (ASD) without co-occurring intellectual impairment face a fairly unique set of challenges as they transition out of secondary school. These students are often quite capable of succeeding in higher education and many of them have interest in pursuing advanced degrees, but the nature of their disability and associated deficits (e.g., poor time management and poor self-regulation) may impede success. Individualized, appropriately timed, and developmentally sensitive transition and support services may promote optimal outcomes for these young people. The goal of this project is to develop a comprehensive program to promote successful transition of students with ASD from high school to post-secondary education.
Detailed description
The investigators propose to refine and then evaluate a novel transition support and intervention program for adolescents and young adults with ASD: STEPS [Stepped Transition in Education Program for Students with ASD]. By targeting improved self-regulation (SR) and self-determination (SD) in young people with ASD, the investigators assert that this program may have positive outcomes with respective to college adjustment and functional behavior. Although the program will be finalized during the first phase of the proposed project, at present STEPS is comprised of two levels (or steps), which match the student's particular needs in relation to transition planning. In Step 1, students facing transition (i.e., have identified the college they will attend (either 2-year or 4-year institution) but are still in high school) and their caregivers will receive information to assist in transition planning, undergo readiness self-assessments (to identify degree of preparedness for post-secondary school), and participate in interactive sessions online and in person to promote self-knowledge and determination. The goal of Step 1 is to assist families and students with transition planning, specifically ensuring that families and students have the tools needed to make informed choices and take necessary steps (e.g., remediating identified skill deficits) to increase the likelihood of a successful transition out of high school. In Step 2, college students with ASD will receive fairly intensive supports and interventions, including individual counseling, structured support services, social integration activities, and coaching to promote academic and social success. The following specific aims are proposed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPS | Experimental | Behavioral: STEPSstructured psychosocial transition support that includes individual counseling, and education/training for parent and school personnel |
| TAU | No intervention | –typical transition services and supports |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Must be 16 to 25 years
- Must have clinical diagnosis of autism spectrum disorder
- Must be preparing for postsecondary education or enrolled in postsecondary education
Key exclusion criteria (2 listed)
- Intellectual disability
- Psychiatric disturbance that warrants immediate treatment
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 |
|---|---|---|
| STEPStime-limited behavioral counseling, online materials, training | Behavioural | STEPS |
Primary outcome
Questionnaire to measure feasibility and program acceptability
Time frame: 16 weeks
parent- and youth self-report measure of utility of program, acceptability, and consumer satisfaction
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 12 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPS in people with Autism Spectrum Disorder, run by Virginia Polytechnic Institute and State University 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 3 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: finished, as of the sponsor's last update on 12 Jul 2019. 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?
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?
Questionnaire to measure feasibility and program acceptability (time frame: 16 weeks). 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 12 Jul 2019.