Autism Spectrum DisorderNSBAANCT05499910
Neuro Strengths-Based Approach to Autism
A study testing NSBAA in people with Autism Spectrum Disorder, run by Baio Enterprises at 1 site in United States.
Trial summary
The Neuro-Strength-Based Approach to Autism (NSBAA) attempts to translate what research has discovered about the autistic brain into terms that autistics, and those involved with autistics, can understand. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- NSBAA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to 30 Jul 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 5-20 SLPs / OTR/Ls, regardless of nationality
- working in a clinical, home or school setting with less than 25 years of experience
- at least 2 years of experience working with autistic clients
Who cannot join
- Minors
- adults unable to consent
- undocumented individuals
- prisoners,
- uncertified therapists
- therapists from Baio Enterprises.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training in Neuro Strengths-Based Approach to Autism
The Neuro-Strength-Based Approach to Autism (NSBAA) attempts to translate what research has discovered about the autistic brain into terms that autistics, and those involved with autistics, can understand. It is not intended to be a new approach to intervention but hopefully a unifying approach to understanding autism that all therapists, educators, clinicians, and parents can use when working with autistic individuals. It was developed by an autistic occupational therapist, based on her lifetime obsession of learning everything she could about how typical brains work, and, following her diagnosis, how the autistic brain works. Being on the autism spectrum herself and having worked with, and interacted with, autistic individuals of all ages and abilities in school, clinical, and personal settings, the author attempts to explain the autistic brain from both the scientific as well as autistic perspectives.
- Conditions
- Autism Spectrum Disorder
- Being tested
- NSBAA
- 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.
NSBAABehavioural
The Neuro Strengths-Based Approach to Autism is an approach that teaches people how the autistic brain works and the best practices for providing intervention.
| Study group | Role | What they receive |
|---|---|---|
| NSBAA | Experimental | The Neuro Strengths-Base Approach to Autism is an approach developed from various research on how the autistic brain works, the approaches that work best to motivate autistic individuals, and how others can understand as well as support behaviors that may occur with autistic individuals. Receives: Behavioral: NSBAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurable change in the participant's satisfaction with their ability to write neuro-strength-based goals
Participants will show a significant increase (50% or higher) in their ratings on the NSBSA Satisfaction With Writing and Implementing Goals For Autistic Clients given to them pre-training, 3 months post-training, and 6 months post-training. They will rate their satisfaction with 28 elements included in the NSBSA Training Modules using a rating scale of 1-5, with 1 being very dissatisfied and 5 being very satisfied. The highest possible score is 140 and the lowest is 28.
Measured: After 16 hours of training
Measurable change in participants' knowledge of the clinical reasoning for the goals they write
Participants will show a significant increase (50% or higher) in the number of goal components they are able to include in their goal, with a maximum of 8, and the number of questions that challenge their reasoning for what they include, with a maximum of 23, in the goals they submit using the Pre- and Post-Training Goal Writing Forms. The highest possible score is 31 if they complete all components and answer all questions. The lowest possible score is 0.
Measured: After 16 hours of training
Secondary outcomes (1)
Measurable change in the completeness of the goals:
Participants will show a significant increase (50% or higher) in the score they receive on the Post-Training Goal Writing Form compared to the Pre-Training Goal Writing Form, using the Pre-and Post-Training Scoring for Goal Writing Form, with the highest possible score being +32 and the lowest score being -16 with an average score of 0.
Measured: After 16 hours of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start4 Oct 2022
- Primary completion13 Dec 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baio Enterprises
- Sponsor type
- University, hospital or other
- Collaborators
- Baio Institute
- Responsible party
- Sponsor
- Investigators
- Blair Braden, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499910
- Sponsor's protocol ID
- STUDY00015835
- Acronym
- NSBAA
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wolff, Michael. (2018). The Complexity of Autism Spectrum Disorders
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. Washington DC: American Psychiatric Association; 2013. 646
Wozniak RH, Leezenbaum NB, Northrup JB, West KL, Iverson JM. The development of autism spectrum disorders: variability and causal complexity. Wiley Interdiscip Rev Cogn Sci. 2017 Jan;8(1-2):10.1002/wcs.1426. doi: 10.1002/wcs.1426. Epub 2016 Dec 1.
PubMed 27906524Ha S, Sohn IJ, Kim N, Sim HJ, Cheon KA. Characteristics of Brains in Autism Spectrum Disorder: Structure, Function and Connectivity across the Lifespan. Exp Neurobiol. 2015 Dec;24(4):273-84. doi: 10.5607/en.2015.24.4.273. Epub 2015 Dec 16.
PubMed 26713076Riosa, Priscilla & Chan, Victoria & Maughan, Andrea & Stables, Victoria & Albaum, Carly & Weiss, Jonathan. (2017). Remediating Deficits or Increasing Strengths in Autism Spectrum Disorder Research: a Content Analysis. Advances in Neurodevelopmental Disorders. 1. 10.1007/s41252-017-0027-3.
Urbanowicz A, Nicolaidis C, den Houting J, Shore SM, Gaudion K, Girdler S, Savarese RJ. An Expert Discussion on Strengths-Based Approaches in Autism. Autism Adulthood. 2019 Jun 1;1(2):82-89. doi: 10.1089/aut.2019.29002.aju. Epub 2019 Apr 13. No abstract available.
PubMed 36601531Donaldson A, Krejcha K, McMillin A. A Strengths-Based Approach to Autism: Neurodiversity and Partnering With the Autism Community. Perspectives of the ASHA Special Interest Groups (2017) 2(1) 56-68
Patten Koenig K. A strength-based frame of reference for autistic individuals. Frames of reference for pediatric occupational therapy (4th edition) (2019)
Patten Koenig K. Authentic Strength-Based Practice: Can Neurotypical Professionals Make a Paradigm Shift? Autism Spectrum News (2020) (Winter)
Leadbitter K, Buckle KL, Ellis C, Dekker M. Autistic Self-Advocacy and the Neurodiversity Movement: Implications for Autism Early Intervention Research and Practice. Front Psychol. 2021 Apr 12;12:635690. doi: 10.3389/fpsyg.2021.635690. eCollection 2021.
PubMed 33912110
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training in Neuro Strengths-Based Approach to Autism
- ClinicalTrials.gov ID
- NCT05499910
- Acronym / sponsor ID
- NSBAA / STUDY00015835
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baio EnterprisesUniversity, hospital or other
- Collaborators
- Baio Institute
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 12 Aug 2022 (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.
The Neuro-Strength-Based Approach to Autism (NSBAA) attempts to translate what research has discovered about the autistic brain into terms that autistics, and those involved with autistics, can understand. It is not intended to be a new approach to intervention but hopefully a unifying approach to understanding autism that all therapists, educators, clinicians, and parents can use when working with autistic individuals. It was developed by an autistic occupational therapist, based on her lifetime obsession of learning everything she could about how typical brains work, and, following her diagnosis, how the autistic brain works. Being on the autism spectrum herself and having worked with, and interacted with, autistic individuals of all ages and abilities in school, clinical, and personal settings, the author attempts to explain the autistic brain from both the scientific as well as autistic perspectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSBAA | Experimental | Behavioral: NSBAAThe Neuro Strengths-Base Approach to Autism is an approach developed from various research on how the autistic brain works, the approaches that work best to motivate autistic individuals, and how others can understand as well as support behaviors that may occur with autistic individuals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 5-20 SLPs / OTR/Ls, regardless of nationality
- working in a clinical, home or school setting with less than 25 years of experience
- at least 2 years of experience working with autistic clients
Key exclusion criteria (6 listed)
- Minors
- adults unable to consent
- undocumented individuals
- prisoners,
- uncertified therapists
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 |
|---|---|---|
| NSBAAThe Neuro Strengths-Based Approach to Autism is an approach that teaches people how the autistic brain works and the best practices for providing intervention. | Behavioural | NSBAA |
Primary outcome
Measurable change in the participant's satisfaction with their ability to write neuro-strength-based goals
Time frame: After 16 hours of training
Participants will show a significant increase (50% or higher) in their ratings on the NSBSA Satisfaction With Writing and Implementing Goals For Autistic Clients given to them pre-training, 3 months post-training, and 6 months post-training. They will rate their satisfaction with 28 elements included in the NSBSA Training Modules using a rating scale of 1-5, with 1 being very dissatisfied and 5 being very satisfied. The highest possible score is 140 and the lowest is 28.
Measurable change in participants' knowledge of the clinical reasoning for the goals they write
Time frame: After 16 hours of training
Participants will show a significant increase (50% or higher) in the number of goal components they are able to include in their goal, with a maximum of 8, and the number of questions that challenge their reasoning for what they include, with a maximum of 23, in the goals they submit using the Pre- and Post-Training Goal Writing Forms. The highest possible score is 31 if they complete all components and answer all questions. The lowest possible score is 0.
1 secondary outcome
Measurable change in the completeness of the goals:
Time frame: After 16 hours of training
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 19 Sep 2024.
- BackgroundWolff, Michael. (2018). The Complexity of Autism Spectrum Disorders
- BackgroundAmerican Psychiatric Association. Diagnostic and statistical manual of mental disorders. Washington DC: American Psychiatric Association; 2013. 646
- Background: PubMed 27906524Wozniak RH, Leezenbaum NB, Northrup JB, West KL, Iverson JM. The development of autism spectrum disorders: variability and causal complexity. Wiley Interdiscip Rev Cogn Sci. 2017 Jan;8(1-2):10.1002/wcs.1426. doi: 10.1002/wcs.1426. Epub 2016 Dec 1.
- Background: PubMed 26713076Ha S, Sohn IJ, Kim N, Sim HJ, Cheon KA. Characteristics of Brains in Autism Spectrum Disorder: Structure, Function and Connectivity across the Lifespan. Exp Neurobiol. 2015 Dec;24(4):273-84. doi: 10.5607/en.2015.24.4.273. Epub 2015 Dec 16.
- BackgroundRiosa, Priscilla & Chan, Victoria & Maughan, Andrea & Stables, Victoria & Albaum, Carly & Weiss, Jonathan. (2017). Remediating Deficits or Increasing Strengths in Autism Spectrum Disorder Research: a Content Analysis. Advances in Neurodevelopmental Disorders. 1. 10.1007/s41252-017-0027-3.
- Background: PubMed 36601531Urbanowicz A, Nicolaidis C, den Houting J, Shore SM, Gaudion K, Girdler S, Savarese RJ. An Expert Discussion on Strengths-Based Approaches in Autism. Autism Adulthood. 2019 Jun 1;1(2):82-89. doi: 10.1089/aut.2019.29002.aju. Epub 2019 Apr 13. No abstract available.
- BackgroundDonaldson A, Krejcha K, McMillin A. A Strengths-Based Approach to Autism: Neurodiversity and Partnering With the Autism Community. Perspectives of the ASHA Special Interest Groups (2017) 2(1) 56-68
- BackgroundPatten Koenig K. A strength-based frame of reference for autistic individuals. Frames of reference for pediatric occupational therapy (4th edition) (2019)
- BackgroundPatten Koenig K. Authentic Strength-Based Practice: Can Neurotypical Professionals Make a Paradigm Shift? Autism Spectrum News (2020) (Winter)
- Background: PubMed 33912110Leadbitter K, Buckle KL, Ellis C, Dekker M. Autistic Self-Advocacy and the Neurodiversity Movement: Implications for Autism Early Intervention Research and Practice. Front Psychol. 2021 Apr 12;12:635690. doi: 10.3389/fpsyg.2021.635690. eCollection 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.
Blair Braden, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSBAA in people with Autism Spectrum Disorder, run by Baio Enterprises 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 6 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 19 Sep 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?
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?
Measurable change in the participant's satisfaction with their ability to write neuro-strength-based goals (time frame: After 16 hours of training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05499910, which also lists 10 linked publications.
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 19 Sep 2024.