Autism Spectrum DisorderPhase 1TAY SUCCESSNCT04953793
High School SUCCESS: Vocational Soft Skills Program for Transition-Age ASD Youth
A Phase 1 study testing TAY SUCCESS in people with Autism Spectrum Disorder, run by Rady Children's Hospital, San Diego at 1 site in United States.
Trial summary
By utilizing community-based participatory research methods, this research was conducted in collaboration with the community through our partnership of researchers, educators, providers and consumers (Active Collaborative Hub for Individuals with ASD to Enhance Vocation and Education- ACHIEVE) to adapt a vocational… Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- TAY SUCCESS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 31 Dec 2020
- 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 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- autism spectrum disorder
- 15-22 yrs
- communicative English language
- enrolled in participating high school or transition program
Who cannot join
- intellectual disability
- Other significant mental health
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital San Diego
San Diego, California, 92123
About this study
By utilizing community-based participatory research methods, this research was conducted in collaboration with the community through our partnership of researchers, educators, providers and consumers (Active Collaborative Hub for Individuals with ASD to Enhance Vocation and Education- ACHIEVE) to adapt a vocational soft skills program, Supported, Comprehensive Cognitive Enhancement \& Social Skills (SUCCESS), for Transition Age Youth (TAY). The first step (years 1-2) involved adapting the intervention for autistic TAY by including feedback from multiple stakeholders and developing a curriculum to be implemented in both High Schools and Transition programs for the specific needs of autistic TAY and alpha piloting it. It involved understanding further the educational context for TAY students and current services available to prepare students for secondary outcomes of employment and/or college through a county wide survey. Step 2 (years 2-3) included pilot testing the feasibility, acceptability, implementation procedures and initial youth outcomes of the TAY SUCCESS intervention and further refining the curriculum and protocols. Findings demonstrated improvements in executive functioning and social functioning targets as well as distal outcomes of self-efficacy, mental health, educational and work behaviors and attitudes. The study results were disseminated through the ACHIEVE group as well as at conferences, website and publication.
Read the detailed description
Aim: With our ACHIEVE partners , develop the High School Supported, Comprehensive Cognitive Enhancement and Social Skills (SUCCESS) program to fit the needs of transition-age youth with ASD within the community educational system.
- Standardize the TAY SUCCESS program by developing a facilitator manual, student workbook and corresponding support person materials.
- Develop a training protocol that can be individualized and implemented within the HS educational system to provide initial training and ongoing coaching for educators to reach and sustain intervention fidelity.
Aim: Conduct a pilot study to examine the feasibility, acceptability, and implementation procedures (recruitment, randomization, retention \& training strategies) of TAY SUCCESS and to obtain estimates of effects to support a future large-scale effectiveness trial.
- Examine intervention feasibility, acceptability, satisfaction, and sustainability.
- Examine preliminary outcomes (executive functioning and social functioning)
- Conditions
- Autism Spectrum Disorder
- Being tested
- TAY SUCCESS, Usual Care
- Keywords
- executive functioning, social cognitions, social communication, transition age youth
- Medical subject headings
- Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAY SUCCESSBehavioural
TAY SUCCESS stands for transition age youth supported, comprehensive cognitive enhancement and social skills. The cognitive-behavioral intervention teaches a number of strategies for executive functioning, social cognitive functioning and social communication.
Usual CareOther
Usual care involved the typical vocational supportive education program delivered in the educational setting
| Study group | Role | What they receive |
|---|---|---|
| TAY SUCCESS intervention | Experimental | This intervention group received the TAY SUCCESS intervention over the course of 1 school year approximately 30 sessions. Receives: Behavioral: TAY SUCCESS |
| Usual Care | Active comparator | This usual care group received typical High school or transition program curriculum over the course of 1 school year. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Rating Inventory of Executive Function (BRIEF-2/BRIEF-A)
Self and Parent report of executive functioning skills. Higher scores indicate more executive functioning problems
Measured: baseline to 6 month post
Delis Kaplan Executive Function Scale (DKEFS)
performance based measure of executive functioning skills. Higher scores indicate more executive functioning abilities
Measured: baseline to 6 month post
Social Responsiveness Scale 2 (SRS-2)
parent report social functioning scale. Higher scores indicate more social functioning problems
Measured: baseline to 6 month post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start6 Nov 2017
- Primary completion20 Jan 2020
- Study completion31 Dec 2020
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A small feasibility randomized clinical trial with randomization occurring at school site level. Two sites randomized to intervention and two sites randomized to control conditions.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rady Children's Hospital, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953793
- Sponsor's protocol ID
- R34MH111491
- Acronym
- TAY SUCCESS
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High School SUCCESS: Vocational Soft Skills Program for Transition-Age ASD Youth
- ClinicalTrials.gov ID
- NCT04953793
- Acronym / sponsor ID
- TAY SUCCESS / R34MH111491
- Conditions
- Autism Spectrum Disorder
- Keywords
- executive functioning, social cognitions, social communication, transition age youth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rady Children's Hospital, San DiegoUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 Jul 2021 (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.
By utilizing community-based participatory research methods, this research was conducted in collaboration with the community through our partnership of researchers, educators, providers and consumers (Active Collaborative Hub for Individuals with ASD to Enhance Vocation and Education- ACHIEVE) to adapt a vocational soft skills program, Supported, Comprehensive Cognitive Enhancement \& Social Skills (SUCCESS), for Transition Age Youth (TAY). The first step (years 1-2) involved adapting the intervention for autistic TAY by including feedback from multiple stakeholders and developing a curriculum to be implemented in both High Schools and Transition programs for the specific needs of autistic TAY and alpha piloting it. It involved understanding further the educational context for TAY students and current services available to prepare students for secondary outcomes of employment and/or college through a county wide survey. Step 2 (years 2-3) included pilot testing the feasibility, acceptability, implementation procedures and initial youth outcomes of the TAY SUCCESS intervention and further refining the curriculum and protocols. Findings demonstrated improvements in executive functioning and social functioning targets as well as distal outcomes of self-efficacy, mental health, educational and work behaviors and attitudes. The study results were disseminated through the ACHIEVE group as well as at conferences, website and publication.
Detailed description
Aim: With our ACHIEVE partners , develop the High School Supported, Comprehensive Cognitive Enhancement and Social Skills (SUCCESS) program to fit the needs of transition-age youth with ASD within the community educational system.
- Standardize the TAY SUCCESS program by developing a facilitator manual, student workbook and corresponding support person materials.
- Develop a training protocol that can be individualized and implemented within the HS educational system to provide initial training and ongoing coaching for educators to reach and sustain intervention fidelity.
Aim: Conduct a pilot study to examine the feasibility, acceptability, and implementation procedures (recruitment, randomization, retention \& training strategies) of TAY SUCCESS and to obtain estimates of effects to support a future large-scale effectiveness trial.
- Examine intervention feasibility, acceptability, satisfaction, and sustainability.
- Examine preliminary outcomes (executive functioning and social functioning)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A small feasibility randomized clinical trial with randomization occurring at school site level. Two sites randomized to intervention and two sites randomized to control conditions.
| Arm | Type | Receives |
|---|---|---|
| TAY SUCCESS intervention | Experimental | Behavioral: TAY SUCCESSThis intervention group received the TAY SUCCESS intervention over the course of 1 school year approximately 30 sessions. |
| Usual Care | Active comparator | Other: Usual CareThis usual care group received typical High school or transition program curriculum over the course of 1 school year. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- autism spectrum disorder
- 15-22 yrs
- communicative English language
- enrolled in participating high school or transition program
Key exclusion criteria (2 listed)
- intellectual disability
- Other significant mental health
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 |
|---|---|---|
| TAY SUCCESSTAY SUCCESS stands for transition age youth supported, comprehensive cognitive enhancement and social skills. The cognitive-behavioral intervention teaches a number of strategies for executive functioning, social cognitive functioning and social communication. | Behavioural | TAY SUCCESS intervention |
| Usual CareUsual care involved the typical vocational supportive education program delivered in the educational setting | Other | Usual Care |
Primary outcome
Behavior Rating Inventory of Executive Function (BRIEF-2/BRIEF-A)
Time frame: baseline to 6 month post
Self and Parent report of executive functioning skills. Higher scores indicate more executive functioning problems
Delis Kaplan Executive Function Scale (DKEFS)
Time frame: baseline to 6 month post
performance based measure of executive functioning skills. Higher scores indicate more executive functioning abilities
Social Responsiveness Scale 2 (SRS-2)
Time frame: baseline to 6 month post
parent report social functioning scale. Higher scores indicate more social functioning problems
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 8 Jul 2021.
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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 Phase 1 study testing TAY SUCCESS in people with Autism Spectrum Disorder, run by Rady Children's Hospital, San Diego 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 4 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 8 Jul 2021. 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?
Behavior Rating Inventory of Executive Function (BRIEF-2/BRIEF-A) (time frame: baseline to 6 month post). The study lists 3 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 8 Jul 2021.