Sensory Processing Difficulties in Adults and Adolescents | NCT02205658

Studies
Sensory Processing Difficulties in Adults and Adolescents

NCT02205658

Sponsor

The Spiral Foundation at OTA Watertown

Status

Unknown status

Last Update Posted

Jul 31, 2014Estimated

Enrollment

1,300Estimated

Phase

Not provided

Conditions

Sensory Processing Dysfunction

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Sep 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Jul 29, 2014

First Submission Date that Met QC Criteria

Jul 29, 2014

First Posted Date

Jul 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2014

Last Update Posted Date

Jul 31, 2014Estimated

Name	Class
Maxwell Hurston Charitable Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensory processing difficulties	This study proposes to measure sensory processing problems by self report	15-20 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Outside of the designated age range
Unable to complete the survey independently

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

95 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals will be a nationally representative sample of US residents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Teresa A May-Benson, ScD	Contact	6179234410	240	tmaybenson@thespiralfoundation.org

Overall Officials

Name	Affiliation	Role
Teresa A May Benson, ScD	The Spiral Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Spiral Foundation	Recruiting	Newton	Massachusetts	02458	United States

Label	URL
Spiral Foundation website	View source

Condition Browse Module

MeSH Terms

ID	Term
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided