Sensory Processing DysfunctionNCT02205658
Sensory Processing Difficulties in Adults and Adolescents
An observational study of Sensory Processing Dysfunction, run by The Spiral Foundation at OTA Watertown at 1 site in United States.
Trial summary
The purpose of this study is to establish normative data for the Adult/Adolescent Sensory History (ASH) and to determine if the ASH is able to discriminate between individuals aged 13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory processing Disorder (SPD), individuals with SPD with no… Read more about this study
- Who is it for?
- Ages 13 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensory Processing Dysfunction
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2014
- Phase
- Observational
- 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 13 to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals will be a nationally representative sample of US residents
Who may be able to join
- Autism and Sensory Processing groups aged 18-95 years, Typical group aged 13-95 years
- Have no self-reported diagnosed neurological motor coordination problem (e.g. cerebral palsy)
- Have no mental health diagnoses involving psychosis (e.g. manic-depression or schizophrenia)
- Be able to read and speak sufficient English as survey is only available in English.
Who cannot join
- Outside of the designated age range
- Unable to complete the survey independently
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Spiral Foundation
Newton, Massachusetts, 02458
Teresa A May-Benson, ScD, 617-923-4410 ext. 240, tmaybenson@thespiralfoundation.org
Teresa A May-Benson, ScD
About this study
Official title: Standardization of the Adult/ Adolescent Sensory History
The purpose of this study is to establish normative data for the Adult/Adolescent Sensory History (ASH) and to determine if the ASH is able to discriminate between individuals aged 13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory processing Disorder (SPD), individuals with SPD with no co-morbid ASD, and individuals who are typically functioning.
It is anticipated that individuals with ASD will have the most problems with sensory processing, those with SPD will also have problems in comparison to typical individuals. It is also hypothesized that the measure will be able to discriminate between the three groups.
- Conditions
- Sensory Processing Dysfunction
- Keywords
- Sensory Processing, Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autism | Individuals, aged 18-95 years, with a pre-existing diagnosis of Autism Spectrum Disorder with or without a co-morbid diagnosis of Sensory Processing Disorder. | |
| Sensory Processing | Individuals, aged 18-95 years, with a pre-existing diagnosis of Sensory Processing Disorder with no co-morbid diagnosis of Autism Spectrum Disorder | |
| Typical | Typically functioning individuals aged 13-95 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory processing difficulties
This study proposes to measure sensory processing problems by self report
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory Processing DysfunctionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Spiral Foundation at OTA Watertown
- Sponsor type
- University, hospital or other
- Collaborators
- Maxwell Hurston Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Teresa A May Benson, ScD, Principal investigator, The Spiral Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205658
- Sponsor's protocol ID
- 1027
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2014
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of the Adult/ Adolescent Sensory History
- ClinicalTrials.gov ID
- NCT02205658
- Acronym / sponsor ID
- 1027
- Conditions
- Sensory Processing Dysfunction
- Keywords
- Sensory Processing, Autism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- The Spiral Foundation at OTA WatertownUniversity, hospital or other
- Collaborators
- Maxwell Hurston Charitable Foundation
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 31 Jul 2014 (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 this study is to establish normative data for the Adult/Adolescent Sensory History (ASH) and to determine if the ASH is able to discriminate between individuals aged 13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory processing Disorder (SPD), individuals with SPD with no co-morbid ASD, and individuals who are typically functioning.
It is anticipated that individuals with ASD will have the most problems with sensory processing, those with SPD will also have problems in comparison to typical individuals. It is also hypothesized that the measure will be able to discriminate between the three groups.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autism | – | –Individuals, aged 18-95 years, with a pre-existing diagnosis of Autism Spectrum Disorder with or without a co-morbid diagnosis of Sensory Processing Disorder. |
| Sensory Processing | – | –Individuals, aged 18-95 years, with a pre-existing diagnosis of Sensory Processing Disorder with no co-morbid diagnosis of Autism Spectrum Disorder |
| Typical | – | –Typically functioning individuals aged 13-95 years |
Who may qualify
- Ages
- 13 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals will be a nationally representative sample of US residents
Key inclusion criteria (4 listed)
- Autism and Sensory Processing groups aged 18-95 years, Typical group aged 13-95 years
- Have no self-reported diagnosed neurological motor coordination problem (e.g. cerebral palsy)
- Have no mental health diagnoses involving psychosis (e.g. manic-depression or schizophrenia)
- Be able to read and speak sufficient English as survey is only available in English.
Key exclusion criteria (2 listed)
- Outside of the designated age range
- Unable to complete the survey independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory processing difficulties
Time frame: 15-20 minutes
This study proposes to measure sensory processing problems by self report
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Spiral Foundation websiteLink provided by the sponsor.
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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.
Teresa A May Benson, ScD principal investigator
The Spiral Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensory Processing Dysfunction, run by The Spiral Foundation at OTA Watertown 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: status not confirmed, as of the sponsor's last update on 31 Jul 2014. 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 Teresa A May-Benson, ScD (6179234410 ext. 240, tmaybenson@thespiralfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory processing difficulties (time frame: 15-20 minutes). 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 31 Jul 2014.