Testing Conversational Agents as a Digital Companion

April 14, 2026 updated by: Friendi.fi Corporation

Pilot Test the Digital Intervention and Research Protocols in a Small Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There is a need and opportunity to improve the supports, transitions, and life outcomes of people with autism spectrum disorder (ASD). Autism affects about 5.4 million adults in America (2.2% or 1 in 45 adults) and at least 78 million people and their families worldwide.1,2 Estimates for children are similar (1 in 44). Classified as a neurodevelopmental disorder, autism typically manifests in early childhood before the age of 3 years and affects social and communication skills, behavior, and outcomes throughout the life span. Teenagers and adults with autism have higher rates of unemployment or underemployment, low participation in post-secondary education, and nearly 40% spend little or no time with friends. Although awareness and scientific interest has grown significantly over the past 20 years, many children and adults are not diagnosed until later in life and much more can be done to improve the life outcomes for people with autism. Large knowledge gaps exist, such as what support strategies are effective for whom and when, and which ones have long-term and meaningful impact. Essentially, the mechanisms of positive change in autism, both behavioral and neurobiological, are largely unknown. Because autism has major implications for lifelong outcomes, cost-effective, affordable and scalable support systems are key, yet missing for many individuals and families.

Given that autism is a complex, heterogenous developmental condition that changes with and affects development, The Lancet Commission on the future of care and clinical research in autism recently stated that single assessments and treatments are never sufficient in ASD. Ongoing assessments and personalized supports that focus on individual strengths and challenges in different contexts across the life span are needed. Meanwhile, autistic people, their family members and community organizations have called for greater emphasis on enhancing quality of life (QOL). The World Health Organization (WHO) defines QOL as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns". In response, investigators at the Center for Autism Research Center at Children's Hospital of Philadelphia leveraged the patient reported outcome measurement information system (PROMIS) developed by the NIH to comprehensively assess QOL in autism, across age groups and genders. The PROMIS Autism Battery (PAB) includes 18 self-report scales for adults that show profound differences between autistic and neurotypical adult samples across virtually all PAB domains, including subjective wellbeing (SWB), relationships (including supports, companionship and social isolation), emotional distress (including anxiety and depression), health (including sleep and mental health), and adulthood (including self-efficacy).

In response to these needs and to NIMH's special topic of interest to "Develop and test new and augment existing digital health interventions that are personalized, engaging, adaptive, sufficiently challenging, and optimal for maximizing real world functional improvements," Friendi.fi Corporation (Friendi.fi) is leveraging its AI-driven technology platform and conversational agent that works on mobile phones through standard SMS (Short Message Service) texting, to be a mobile digital companion to autistic people in early adulthood. The platform and agent is used to scale a strong theoretical and conceptual approach that has proven successful in meeting the individual needs and targeted outcomes of autistic students through a collaborative model for promoting competence and success (COMPASS) combined with Goal Attainment Scaling (GAS). COMPASS considers the challenges and strengths of the individual and environment, as well as the balance between them. Critically, the role of the environment as an enabler (support) or barrier (challenge) to success lowers the burden on autistic individuals as a source of dysfunction. In this model, technology is viewed as an environmental support that builds on the strengths, needs, and goals of the individual.

AYA will be enrolled in a 10-week experiential trial using the novel digital coaching program and agent. The trial serves several purposes: (1) It will test the preliminary efficacy of the digital intervention by assessing within-person change over time. The trial is powered to detect a minimal important change (MIC) in the proposed standardized and normalized PAB measures; (2) The observed effect size will be used to finalize the sample size calculation for a properly-powered future randomized control trial (RCT); (3) By including a control group, the feasibility of all clinical and study protocols is tested prior to implementing the RCT. Twenty-six AYA will receive daily coaching via the digital agents (AGENT group) and twelve will receive traditional coaching using face-to-face meetings with human counselors (CONTROL group). In both groups, intervention delivery and patient-reported outcomes data are collected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Bloomington, Indiana, United States, 47408
        • Recruiting
        • Indiana Institute on Disability and Community
        • Contact:
        • Principal Investigator:
          • Judith Gross, PhD
      • Muncie, Indiana, United States, 47306
        • Recruiting
        • Ball State University
        • Contact:
        • Principal Investigator:
          • Evette Simmons-Reed, PhD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Children's Autism Center502-588-0736 x 50608
        • Contact:
        • Principal Investigator:
          • Grace Kuravackel, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AGENT
goal coaching intervention via digital companion
Behavioral: self-directed goal coaching
a collaborative model for promoting competence and success (COMPASS) combined with Goal Attainment Scaling (GAS).
Active Comparator: CONTROL
goal coaching using traditional face-to-face meetings with human counselors and paper-and-pencil materials.
Behavioral: self-directed goal coaching
a collaborative model for promoting competence and success (COMPASS) combined with Goal Attainment Scaling (GAS).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global Mental Health
Time Frame: 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.
10 weeks
Anxiety
Time Frame: 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.
10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Goal Attainment
Time Frame: 10 weeks
Goal Attainment Scale (GAS) which assesses the extent to which individualized goals are achieved over a specified period of time relative to an expected level of goal achievement, not absolute ability or symptom severity. Scores range from 1 (no progress) to 5 (exceeds goal). Higher scores indicate a better outcome.
10 weeks
Self Efficacy
Time Frame: 10 weeks
PROMIS_SF_v1.0_Self_Effic-General_4a. Patient-Reported Outcomes Measurement Information System, 4 items assessing an individual's confidence in their ability to handle problems, achieve goals, and manage difficult or unexpected situations. Scored using standardized T-scores. Minimum possible T-score approximately 28; Maximum possible score approximately 69. Raw scores range from 4 to 20. Higher scores indicate a better outcome.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Friendi.fi Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Indiana University
University of Nebraska
University of Louisville
Ball State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chantal Kerssens, PhD, Friendi.fi Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14023 (City of Hope Medical Center)
  • 5R44MH134719-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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