Autism Spectrum DisorderNCT05695885
STEPS Implementation Trial
A study testing STEPS and Services as usual (SAU) in people with Autism Spectrum Disorder, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial summary
This study will inform understanding of how to support emerging adults with autism spectrum disorder (ASD). The investigators will use a theoretically informed and research-based transition support program developed for people with ASD and test how effective it is when delivered by community agencies. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- STEPS and Services as usual (SAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 31 Dec 2025
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 16-25 years of age
- have confirmed diagnosis of ASD
- want to participate in STEPS
- have a caregiver/parent who can complete assessments
Who cannot join
- presence of suicidal/homicidal intent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center o=for Youth Development and Intervention
Tuscaloosa, Alabama, 35487
Susan W White, PhD, 205-348-1967, swwhite1@ua.edu
About this study
Official title: Stepped Transition in Education Program for Emerging Adults With Autism: Pilot Effectiveness Trial
This study will inform understanding of how to support emerging adults with autism spectrum disorder (ASD). The investigators will use a theoretically informed and research-based transition support program developed for people with ASD and test how effective it is when delivered by community agencies. Results will provide information on the effectiveness of the program as well as on mechanisms of change and contextual factors that promote or impede implementation.
Read the detailed description
The long-term goal of this research is to improve adult outcomes for people with autism spectrum disorder (ASD). Autistic adolescents and young adults tend to have worse outcomes with respect to employment, education, and quality of life, than neurotypical peers. These outcomes include under-enrollment into college, unemployment, and limited functional independence. Research-informed transition planning that addresses core impairments in skills related to adult autonomy, including self-knowledge, self-determination, and self-regulation, may improve outcomes for this growing population. In prior research, investigators developed a stakeholder involved transition program (STEPS) and found it to be feasible, acceptable, and efficacious. Data from a small randomized controlled trial (RCT) focusing on feasibility indicated that it was acceptable to participants and suggested STEPS was effective in improving readiness for transition to adulthood. The team will now test the effectiveness of STEPS, and engagement of target mechanisms, in partnership with four community agencies. This study is designed as a Hybrid Type 1, which focuses primarily on intervention effectiveness with a secondary focus on factors related to implementation. Immediate (post-treatment) and longer-term (six month follow-up) clinical outcomes of adult functional outcomes and vocational engagement will be assessed. The degree to which STEPS leads to change in the theoretical mediating mechanisms (i.e., adult autonomy skills) will be examined, as well as a formal test of mediation (i.e., the degree to which change in adult autonomy skills leads to change in adult functional outcomes). Providers will provide qualitative information on implementation such as thoughts on STEPS' cultural sensitivity, and quantitative data on the appropriateness, feasibility, and acceptability of STEPS. Providers' sustained use of STEPS with clients in the six months after study enrollment has ended will also be tracked. This research will produce findings that have the potential to shift clinical practice related to transition to adulthood for people with ASD. In light of the fact that approximately 70,000 people with ASD age into adulthood every year and the economic burden associated with ASD, the potential public health impact of this research is considerable.
- Conditions
- Autism Spectrum Disorder
- Being tested
- STEPS, Services as usual (SAU)
- Keywords
- transition, adulthood, employment, education
- 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
behavioral counseling
Services as usual (SAU)Behavioural
behavioral counseling normally provided
| Study group | Role | What they receive |
|---|---|---|
| STEPS | Experimental | 14 session counseling targeting adult independence skills Receives: Behavioral: STEPS |
| Control | Other | Services as usual Receives: Behavioral: Services as usual (SAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition Readiness Scale-Revised
This caregiver and self-report questionnaire has a range of possible scores from 30 to 120, with higher scores indicating greater readiness.assigned condition. Scores are categorical in nature: 0 = no evidence of progression toward goals, 1 = some evidence, 2 = strong evidence of progression toward goals.
Measured: 30 days
Secondary outcomes (2)
Relationships, Employment, Autonomy, and Life Satisfaction
This is a questionnaire completed by caregiver and participant. Higher scores indicate greater autonomy, independence, and satisfaction. On the self-report measure scores range as follows for Frequency: social engagement (0-56), outside meaningful activities (0-32), self-care (0-88), independence (0-56), and romance (0-16) and level of support ranges are: social engagement (0-68), outside meaningful activities (0-32), self-care (0-76), independence (0-48), finances (0-12), and satisfaction (0-132). On caregiver-report, frequency subscales range as follows: degree of social contact (0-28), social initiation (0-60), work/finances (0-64), autonomy (0-56), care of self and home (0-72), and support subscales range as follows: social engagement (0-68), self-care (0-144), work activity (0-28), independence (0-16), and finances (0-24).
Measured: 30 days
Rehabilitation Success
This brief interview on progress made toward educational or employment goals is completed with participant and caregiver, conducted by an examiner unaware of assigned condition. Scores are categorical in nature: 0 = no evidence of progress toward goals, 1 = some evidence of progress toward goals, 2 = moderate evidence of progress toward goals, and 3 = clear strong evidence of progress toward goals. Higher scores indicate greater goal attainment.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan White, University of Alabama, Tuscaloosa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695885
- Sponsor's protocol ID
- 22-07-5746
- Status last verified
- Aug 2024
- First submitted
- 13 Jan 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we submit de-identified data to NIH repository (NDA)
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Transition in Education Program for Emerging Adults With Autism: Pilot Effectiveness Trial
- ClinicalTrials.gov ID
- NCT05695885
- Acronym / sponsor ID
- 22-07-5746
- Conditions
- Autism Spectrum Disorder
- Keywords
- transition, adulthood, employment, education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jan 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.
This study will inform understanding of how to support emerging adults with autism spectrum disorder (ASD). The investigators will use a theoretically informed and research-based transition support program developed for people with ASD and test how effective it is when delivered by community agencies. Results will provide information on the effectiveness of the program as well as on mechanisms of change and contextual factors that promote or impede implementation.
Detailed description
The long-term goal of this research is to improve adult outcomes for people with autism spectrum disorder (ASD). Autistic adolescents and young adults tend to have worse outcomes with respect to employment, education, and quality of life, than neurotypical peers. These outcomes include under-enrollment into college, unemployment, and limited functional independence. Research-informed transition planning that addresses core impairments in skills related to adult autonomy, including self-knowledge, self-determination, and self-regulation, may improve outcomes for this growing population. In prior research, investigators developed a stakeholder involved transition program (STEPS) and found it to be feasible, acceptable, and efficacious. Data from a small randomized controlled trial (RCT) focusing on feasibility indicated that it was acceptable to participants and suggested STEPS was effective in improving readiness for transition to adulthood. The team will now test the effectiveness of STEPS, and engagement of target mechanisms, in partnership with four community agencies. This study is designed as a Hybrid Type 1, which focuses primarily on intervention effectiveness with a secondary focus on factors related to implementation. Immediate (post-treatment) and longer-term (six month follow-up) clinical outcomes of adult functional outcomes and vocational engagement will be assessed. The degree to which STEPS leads to change in the theoretical mediating mechanisms (i.e., adult autonomy skills) will be examined, as well as a formal test of mediation (i.e., the degree to which change in adult autonomy skills leads to change in adult functional outcomes). Providers will provide qualitative information on implementation such as thoughts on STEPS' cultural sensitivity, and quantitative data on the appropriateness, feasibility, and acceptability of STEPS. Providers' sustained use of STEPS with clients in the six months after study enrollment has ended will also be tracked. This research will produce findings that have the potential to shift clinical practice related to transition to adulthood for people with ASD. In light of the fact that approximately 70,000 people with ASD age into adulthood every year and the economic burden associated with ASD, the potential public health impact of this research is considerable.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel RCT
| Arm | Type | Receives |
|---|---|---|
| STEPS | Experimental | Behavioral: STEPS14 session counseling targeting adult independence skills |
| Control | Other | Behavioral: Services as usual (SAU)Services as usual |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 16-25 years of age
- have confirmed diagnosis of ASD
- want to participate in STEPS
- have a caregiver/parent who can complete assessments
Key exclusion criteria (1 listed)
- presence of suicidal/homicidal intent
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 |
|---|---|---|
| STEPSbehavioral counseling | Behavioural | STEPS |
| Services as usual (SAU)behavioral counseling normally provided | Behavioural | Control |
Primary outcome
Transition Readiness Scale-Revised
Time frame: 30 days
This caregiver and self-report questionnaire has a range of possible scores from 30 to 120, with higher scores indicating greater readiness.assigned condition. Scores are categorical in nature: 0 = no evidence of progression toward goals, 1 = some evidence, 2 = strong evidence of progression toward goals.
2 secondary outcomes
Relationships, Employment, Autonomy, and Life Satisfaction
Time frame: 30 days
Rehabilitation Success
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Yes. we submit de-identified data to NIH repository (NDA)
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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.
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 and Services as usual (SAU) in people with Autism Spectrum Disorder, run by University of Alabama, Tuscaloosa 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 1 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 16 Aug 2024. 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 Susan W White, PhD (2053481967, swwhite1@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition Readiness Scale-Revised (time frame: 30 days). 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 16 Aug 2024.