Testing Conversational Agents as a Digital Companion

NCT07533331 | Recruiting DMC

• 2 other identifiers: 140235R44MH134719-03
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Autism

Keywords

Digital companions; mental health; autistic young adults; self-determination; goal attainment

Outcome Measures

Primary Outcomes (2)

• Global Mental Health

  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.

  10 weeks

• Anxiety

  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.

  10 weeks

Secondary Outcomes (2)

• Goal Attainment

  10 weeks

• Self Efficacy

  10 weeks

Study Arms (2)

AGENT

EXPERIMENTAL

goal coaching intervention via digital companion

Behavioral: self-directed goal coaching

CONTROL

ACTIVE COMPARATOR

goal coaching using traditional face-to-face meetings with human counselors and paper-and-pencil materials.

Behavioral: self-directed goal coaching

Interventions

self-directed goal coaching BEHAVIORAL

a collaborative model for promoting competence and success (COMPASS) combined with Goal Attainment Scaling (GAS).

AGENT; CONTROL

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Friendi.fi Corporation: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Louisville: collaborator
• Indiana University: collaborator
• Ball State University: collaborator
• University of Nebraska: collaborator

Study Sites (3)

Indiana Institute on Disability and Community

Bloomington, Indiana, 47408, United States

RECRUITING

Ball State University

Muncie, Indiana, 47306, United States

RECRUITING

Norton Children's Autism Center502-588-0736 x 50608

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Chantal Kerssens, PhD

  Friendi.fi Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Kerssens, PhD

CONTACT

404-282-0378; chantal@friendi.fi

Cheri Maggard, MA

CONTACT

404-282-0378; cheri@friendi.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a pilot clinical trial, where participants are randomly assigned to one of two groups. All participants will receive a health coaching program. What differs between the groups is how the program is delivered. Participants in the CONTROL group will be coached using traditional methods (face-to-face meetings and paper-and-pencil materials). The digital intervention group will complete all coaching components, including intake, coaching, progress monitoring and evaluation, using a digital companion (AGENT group). At the end of the program, all participants complete the same assessments to see if they benefited from the intervention, and if the delivery mode made a difference.

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 16, 2026
• Study Start: March 21, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (3)