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An Online Evaluation of Work Chat

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Work Chat
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Autism Spectrum Disorder 18 years or older Has 4th grade or higher reading level Employed Has access to a computer, laptop, or tablet that has connection to the internet and a camera (not including smartphone) Exclusion Criteria: -

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Work Chat Later

Work Chat Now

Arm Description

This group will not receive Work Chat during the study, but will receive Work Chat access after data collection is complete.

Behavioral: Work Chat: An Interactive Virtual Workday Work Chat will be a simulation training using virtual characters to role-play conversations. It will contain conversations with a coworker, a customer, and a supervisor within a workplace setting.

Outcomes

Primary Outcome Measures

Change in Theory of Mind - Hinting Task
Measured by the hinting task (Corcoran, Mercer, & Frith, 1995), which comprises 10 short stories describing an interaction between two characters, all of which end with one of the characters making a hint. At the end of each passage, the participant is asked what the hint meant. If they give a correct response (score 2), they move onto the next item. If they fail, they are provided with extra information to help interpret the hint. A correct recognition of the hint at this stage scores 1. Total score can be 0-20, with a higher score being a better outcome.
Change in Emotion Recognition Ability - MiniPONs
Measured by the MiniPONS, which is a short, multichannel version of the established Profile of Nonverbal Sensitivity (PONS) test (Rosenthal et al., 1979). The short multichannel version (64 items) available here correlates very highly with the full version and shows reasonable construct validity through significant correlations with other tests of emotion recognition ability. A total score is calculated at the end, total score can be 0-64, with a higher score being a better outcome.
Greater sustained employment by 9 Months
Self-report employment surveys completed at baseline and follow ups. Employment will be tracked as 0 (no job) and 1 (job). Higher scores indicate a better outcome.
Change in Managing Emotions
The Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) is an ability-based test designed to measure the four branches of the EI model of Mayer and Salovey. This study will only use the Managing Emotions Subscale, which measures the ability to be be open to emotions and feelings and integrate emotions with thinking. There are 29 scenarios presented, with higher score ranges indicating a positive outcome and lower score ranges indicating a worse outcome. The score ranges are as follows: Improve (worse), Consider Developing, Competent, Skilled, and Expert (positive).

Secondary Outcome Measures

Change in Anxiety
Measured by the Social Interaction Anxiety Scale (SIAS) self-report survey. Items are on a 5 point scale with 0 being "not at all" and 4 being "extremely". Total score can be 0-80, with higher scores indicating higher anxiety, a worse outcome.

Full Information

First Posted
July 7, 2023
Last Updated
July 14, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH), SIMmersion, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05949086
Brief Title
An Online Evaluation of Work Chat
Official Title
An Online Evaluation of Work Chat: A Virtual Workday Among Employed Autistic Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2023 (Actual)
Primary Completion Date
August 10, 2024 (Anticipated)
Study Completion Date
December 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH), SIMmersion, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is aiming to see if it is feasible for the intervention Work Chat to be delivered in a completely online setting to adults with autism spectrum disorder.
Detailed Description
Nearly 50,000 youth with autism spectrum disorder (ASD) transition from high school to adult life each year, with only 25% of these transition-age youth with ASD (TAY-ASD) getting jobs within 2 years of graduation. TAY-ASD's ability to sustain employment is even more challenging due in part to their social cognitive deficits (e.g., poorly reading social cues) that disrupt communicating with customers, coworkers, and supervisors. Research shows nearly 90% of job dismissals among TAY-ASD are attributed to poor work-based social functioning (e.g., poorly communicating with upset customers). The subsequent unemployment has damaging effects on their mental, physical, and economic health. A critical gap in federally-mandated services to support youth with ASD as they transition from school-to-adult life is the lack of evidence-based practice to enhance their work-based social functioning. Given that TAY-ASD report computerized training tools are highly acceptable and improve their real-world outcomes, the investigators propose to address this critical barrier to sustained employment by developing and evaluating a novel and scalable computerized training tool to enhance their conversations with customers, coworkers and supervisors at work. The investigators are aiming to see if it is feasible for Work Chat to be delivered in a completely online setting and not within schools or other sites. The investigators are also evaluating the tool specifically with employed adults who have autism spectrum disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Work Chat Later
Arm Type
No Intervention
Arm Description
This group will not receive Work Chat during the study, but will receive Work Chat access after data collection is complete.
Arm Title
Work Chat Now
Arm Type
Experimental
Arm Description
Behavioral: Work Chat: An Interactive Virtual Workday Work Chat will be a simulation training using virtual characters to role-play conversations. It will contain conversations with a coworker, a customer, and a supervisor within a workplace setting.
Intervention Type
Behavioral
Intervention Name(s)
Work Chat
Intervention Description
Work Chat will be a simulation training using virtual characters to role-play conversations. It will contain conversations with a coworker, a customer, and a supervisor within a workplace setting.
Primary Outcome Measure Information:
Title
Change in Theory of Mind - Hinting Task
Description
Measured by the hinting task (Corcoran, Mercer, & Frith, 1995), which comprises 10 short stories describing an interaction between two characters, all of which end with one of the characters making a hint. At the end of each passage, the participant is asked what the hint meant. If they give a correct response (score 2), they move onto the next item. If they fail, they are provided with extra information to help interpret the hint. A correct recognition of the hint at this stage scores 1. Total score can be 0-20, with a higher score being a better outcome.
Time Frame
Baseline and posttest (approximately 6 weeks after baseline)
Title
Change in Emotion Recognition Ability - MiniPONs
Description
Measured by the MiniPONS, which is a short, multichannel version of the established Profile of Nonverbal Sensitivity (PONS) test (Rosenthal et al., 1979). The short multichannel version (64 items) available here correlates very highly with the full version and shows reasonable construct validity through significant correlations with other tests of emotion recognition ability. A total score is calculated at the end, total score can be 0-64, with a higher score being a better outcome.
Time Frame
Baseline and posttest (approximately 6 weeks after baseline)
Title
Greater sustained employment by 9 Months
Description
Self-report employment surveys completed at baseline and follow ups. Employment will be tracked as 0 (no job) and 1 (job). Higher scores indicate a better outcome.
Time Frame
9 Month Follow Up (approximately 9 Months after randomization)
Title
Change in Managing Emotions
Description
The Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) is an ability-based test designed to measure the four branches of the EI model of Mayer and Salovey. This study will only use the Managing Emotions Subscale, which measures the ability to be be open to emotions and feelings and integrate emotions with thinking. There are 29 scenarios presented, with higher score ranges indicating a positive outcome and lower score ranges indicating a worse outcome. The score ranges are as follows: Improve (worse), Consider Developing, Competent, Skilled, and Expert (positive).
Time Frame
Baseline and posttest (approximately 6 weeks after baseline)
Secondary Outcome Measure Information:
Title
Change in Anxiety
Description
Measured by the Social Interaction Anxiety Scale (SIAS) self-report survey. Items are on a 5 point scale with 0 being "not at all" and 4 being "extremely". Total score can be 0-80, with higher scores indicating higher anxiety, a worse outcome.
Time Frame
Baseline and posttest (approximately 6 weeks after baseline)
Other Pre-specified Outcome Measures:
Title
Change in Social Competence/Applied Social Ability
Description
Measured by Social Skills Performance Assessment (SSPA). Roleplay performance: The SSPA includes two brief (3-minute) roleplays in which participants engage in a conversation with an unknown confederate who plays the role of a new neighbor(NN) or a landlord (LL). The NN and LL role plays were video recorded at the pre- and posttest visits and were blindly rated by use of an anchoring system. The NN roleplay was scored on eight items via a 5-point scale (e.g., 5,very interested, to 1, very disinterested), and the LL roleplay was scored on nine items via a 5-point scale (e.g., 5,very focused, to 1, very unfocused). The two role-play scores were combined to create one total pretest score and one total posttest score. Sum scores could have a minimum of 17 and maximum of 85. Higher scores indicated better skills.
Time Frame
Baseline and posttest (approximately 6 weeks after baseline)
Title
Change in Interpersonal Communication at Work
Description
Measured by the Interpersonal Communication at Work Scale. There are 4 items on a scale from 1 (Less than once per month or never) to 5 (several times per day). A higher score indicates a more negative outcome.
Time Frame
Baseline and posttest (approximately 6 weeks after baseline) and 3-month, 6-month, 9-month follow up after randomization.
Title
Change in Job Satisfaction
Description
Measured by the Job Satisfaction of Persons with Disability Scale. There are 14 items on a scale from 1 Strongly Disagree to 7 Strongly Agree with a higher score indicating a more positive score. Total scores can range from 14-98.
Time Frame
Baseline and posttest (approximately 6 weeks after baseline) and 3-month, 6-month, 9-month follow up after randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Autism Spectrum Disorder 18 years or older Has 4th grade or higher reading level Employed Has access to a computer, laptop, or tablet that has connection to the internet and a camera (not including smartphone) Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Ross, MS
Phone
7347642368
Email
rossbrit@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew J Smith, PhD
Phone
734-764-9322
Email
mattjsmi@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Smith, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Ross
Phone
734-764-2368
Email
rossbrit@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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An Online Evaluation of Work Chat

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