Testing Conversational Agents as a Digital Companion

NCT07533331 · tracked via the Priya Life Science USA tracker

Sponsor

Friendi.fi Corporation

Phase

Not applicable

Started

2026-03-21

Last updated

2026-04-16

Condition(s) studied

Autism

Investigational drug(s) / intervention(s)

self-directed goal coaching

self-directed goal coaching: a collaborative model for promoting competence and success (COMPASS) combined with Goal Attainment Scaling (GAS).

Study summary

There is a need and opportunity to improve the supports, transitions, and life outcomes of people with autism spectrum disorder. Compared to their neurotypical peers, autistic teenagers and adults report poorer mental health and quality of life and have higher rates of unemployment or underemployment and low participation in post-secondary education. Nearly 40% spend little or no time with friends. Although autism awareness has grown considerably in recent decades, much more can be done to improve the life outcomes for people with autism. Cost-effective, affordable and scalable support systems are needed as well as ongoing assessments and personalized support plans that focus on individual strengths and challenges in different contexts (college, work, community life) across the life span. This requires adaptive interventions and regular consultation with and between stakeholders. It also requires a rigorous approach to measuring outcomes that are not one-size-fits-all and do not expect everyone to reach, or have, the same goals. To meet these needs, the investigators leverage an already successful technology platform with two conversational-relational agents to be a digital companion and coach to autistic young adults (AYA, ages 18 to 35 years). The technology will be used to scale a strong theoretical and conceptual approach that has proven successful in meeting the individual needs and personalized outcomes of autistic students through a collaborative consultation model for promoting competency and success (COMPASS) combined with Goal Attainment Scaling (GAS). To deliver personalized coaching, empathy, and outcomes at scale, GAS/COMPASS was translated into software-driven evidence-based coaching protocols in collaboration with clinical, academic, and community partners. In this study, the digital coaching program and all research protocols are pilot tested in a 10-week experiential trial with AYA.

Eligibility

Sex

ALL

Min age

18 Years

Max age

35 Years

Healthy volunteers

Inclusion Criteria: * formal autism diagnosis per qualified professional. * holds a job, volunteers, or attends college/vocational school where they participate in regular course work, classrooms, settings. * drives or independently uses public transportation/ride share. * makes medical decisions and manages finances. * purchases groceries and cooks meals. * engages in leisure activities with peers. * reads and comprehends spoken and written English. * able to complete surveys and informed consent independently. * able and willing to identify a trusted informant (such as a good friend, parent proxy or mentor who knows them well) for additional context, if needed. (11) 24/7 access to a personal mobile phone with SMS text capability. Exclusion Criteria: * an intellectual disability. * serious mental illness requiring psychiatric evaluation, intervention or in-patient hospitalizations in the past month. * suicidal ideation or attempts in the past month. * diagnosed sleep disorder in the past month. * pregnancy. * planned absences that interfere with study participation.

Primary outcome measure(s)

Global Mental Health — 10 weeks
PROMIS Scale v1.2-Global Mental 2a: Patient-Reported Outcomes Measurement Information System, 2 items assessing overall mental health, emotional well-being, and quality of life. Minimum possible standardized T-score: approximately 21; Maximum possible score: approximately 68. Raw scores range from 2 to 10. Higher scores indicate a better outcome.
Anxiety — 10 weeks
PROMIS Short Form v1.0-Anxiety 4a. Patient-Reported Outcomes Measurement Information System, 4 items assessing emotional distress related to fears, worries, nervousness experienced over the past 7 days. Scored using IRT-based T-scores. Minimum possible T-score approximately 40; Maximum possible score approximately 82. Raw scores range from 4 to 20. Higher scores indicate a worse outcome.

Trial sites (3)

Facility	City	Region	Status
Indiana Institute on Disability and Community	Bloomington	Indiana	Recruiting
Ball State University	Muncie	Indiana	Recruiting
Norton Children's Autism Center502-588-0736 x 50608	Louisville	Kentucky	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07533331 on ClinicalTrials.gov ↗ ← All trials in the USA