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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05949086
Other study ID # HUM00228606
Secondary ID R44MH123359-01
Status Recruiting
Phase N/A
First received
Last updated
Start date July 7, 2023
Est. completion date December 10, 2024

Study information

Verified date July 2023
Source University of Michigan
Contact Brittany Ross, MS
Phone 7347642368
Email rossbrit@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 10, 2024
Est. primary completion date August 10, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Autism Spectrum Disorder - 18 years or older - Has 4th grade or higher reading level - Employed or Unemployed and searching for employment within the next 3 months - Has access to a computer, laptop, or tablet that has connection to the internet and a camera (not including smartphone) Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Work Chat
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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (3)

Lead Sponsor Collaborator
University of Michigan National Institute of Mental Health (NIMH), SIMmersion, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Social Competence/Applied Social Ability 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. Baseline and posttest (approximately 6 weeks after baseline)
Other Change in Interpersonal Communication at Work 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. Baseline and posttest (approximately 6 weeks after baseline) and 3-month, 6-month, 9-month follow up after randomization.
Other Change in Job Satisfaction 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. Baseline and posttest (approximately 6 weeks after baseline) and 3-month, 6-month, 9-month follow up after randomization.
Primary 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. Baseline and posttest (approximately 6 weeks after baseline)
Primary 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. Baseline and posttest (approximately 6 weeks after baseline)
Primary 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. 9 Month Follow Up (approximately 9 Months after randomization)
Primary 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). Baseline and posttest (approximately 6 weeks after baseline)
Secondary 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. Baseline and posttest (approximately 6 weeks after baseline)
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