Clinical trial NCT05565482: Work Chat: An Interactive Virtual Workday
Official title: Social Cognitive Skills Training for Work
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: social skills
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: SIMmersion, LLC
name: Michigan Career and Technical Institute (MCTI)
name: National Institute of Mental Health (NIMH)
name: Michigan State University
name: University of Pittsburgh
First posted: 2022-10-04
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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 work-based social functioning. Given that TAY-ASD report computerized training tools (developed by the investigators and others) 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 participant conversations with customers, coworkers and supervisors at work.

The investigators propose to develop and test the effectiveness of Social Cognitive and Affective Learning for Work (Work Chat: An Interactive Virtual Workday), a computerized training tool. Work Chat will have three tiers of instruction designed to help TAY-ASD prepare for effective workplace communication. Tier 1 will adapt existing evidence-based practices to design an e-learning curriculum that trains social cognitive strategies to help guide work-related conversations (e.g., reading social cues or regulating emotions during supervisor feedback). In Tier 2, SIMmersion's PeopleSim® technology will enable TAY-ASD to apply social cognitive strategies learned in Tier 1 to repetitively practice simulated conversations with a fictional customer, coworker, or supervisor. In Tier 3, SIMmersion will innovate PeopleSim to exist in an interactive 3-D environment to create a virtual workday with interconnected activities were the actions made early in the day influence conversations later in the day (e.g., a poor customer interaction may result in constructive feedback from a supervisor).

Phase I (Feasibility) was completed with application HUM00177878.

Phase II (Efficacy) Aims:

Aim 1) Complete Work Chat development using an iterative process that includes initial and ongoing individual-level feedback from Phase I participants and the community and scientific advisory boards to complete the product that will be evaluated in Aims 2-3.

Aim 2) Conduct a Randomized Controlled Effectiveness-Implementation hybrid trial in a school setting to evaluate Work Chat. The investigators will recruit and randomly assign n=338 TAY-ASD (90% of sample frame) enrolled in school-based standard transition services (STS) to the Work Chat group (STS+SW) or a STS group (STS). The hypothesis is that STS+SW, compared to STS, will show greater gains in: (H1) social cognition and (H2) work-based social functioning; as well as (H3) reduced anxiety about work-based social encounters, and (H4) greater sustained employment by 9-month follow-up. The investigators will test mechanistic hypotheses (H5a-b) that social cognitive ability (H5a) and work-based social functioning (H5b) mediate the effect of treatment (STS+SW vs. STS) on sustained employment. For the implementation evaluation, the investigators will conduct a multilevel, mixed-method process evaluation of Work Chat's acceptability, appropriateness, and feasibility.

Aim 3) Use community participatory research methods to prepare for commercialization. The investigators will conduct a parallel multilevel, mixed method implementation evaluation that focuses on the Work Chat delivery system regarding its feasibility, sustainability, scalability, and generalizability by conduct focus groups with delivery staff and administrators. These groups will discuss potential facilitators and barriers to Work Chat implementation, adoption, and sustainability.


Eligibility criteria: Inclusion Criteria for Students:

* At least 16 years old
* Screened for ASD via parent report using the Social Responsivity Scale 2nd Edition (SRS-2) (a score of 65T or higher on the SRS-2 will be used to reduce false positives) or have a record with an engaged site of ASD
* Have at least a 4th grade reading level measured by the Wide Range Achievement Test 4th edition (this may be provided by sites)

Exclusion Criteria:

* Medical illness that may significantly compromise cognition (e.g., moderate or greater traumatic brain injury)
* uncorrected vision, or hearing problems that prevent using the software

Inclusion Criteria for Teachers/Administrators

* 18 or older (no maximum age)
* Currently working at an engaged site

Primary outcomes:
measure: Change in Theory of Mind - Hinting Task
timeFrame: Baseline and posttest (approximately 6 weeks after baseline)
measure: Change in Emotion Recognition Ability - MiniPONs
timeFrame: Baseline and posttest (approximately 6 weeks after baseline)
measure: Change in Emotion Regulation - Emotion Dysregulation Inventory Short Form (Reactivity Index Short Form)
timeFrame: Baseline and posttest (approximately 6 weeks after baseline)
measure: Greater sustained employment by 9 Months
timeFrame: 9 Month Follow Up (approximately 9 Months after posttest)
measure: Change in Managing Emotions
timeFrame: Baseline and posttest (approximately 6 weeks after baseline)
Secondary outcomes:
measure: Change in Anxiety
timeFrame: Baseline and posttest (approximately 6 weeks after baseline)
measure: Greater Gains/Change in Workplace Functioning - Workplace Behavior Inventory (WBI)
timeFrame: Baseline and posttest (approximately 6 weeks after baseline)
Other outcomes:
measure: Change in Social Competence/Applied Social Ability
timeFrame: Baseline and posttest (approximately 6 weeks after baseline)
Locations:
city: Plainwell
country: United States
facility: Michigan Career and Technical Institute
state: Michigan
Study officials:
affiliation: University of Michigan
name: Matthew J Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: