Autism Spectrum Disorder Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
United States
Indiana
Indiana Institute on Disability and Community
RECRUITING
Bloomington
Ball State University
RECRUITING
Muncie
Kentucky
Norton Children's Autism Center502-588-0736 x 50608
RECRUITING
Louisville
Contact Information
Primary
Chantal Kerssens, PhD
chantal@friendi.fi
404-282-0378
Backup
Cheri Maggard, MA
cheri@friendi.fi
404-282-0378
Time Frame
Start Date: 2026-03-21
Estimated Completion Date: 2026-10
Participants
Target number of participants: 38
Treatments
Experimental: AGENT
goal coaching intervention via digital companion
Active_comparator: CONTROL
goal coaching using traditional face-to-face meetings with human counselors and paper-and-pencil materials.
Related Therapeutic Areas
Sponsors
Collaborators: Indiana University, Ball State University, University of Nebraska, University of Louisville, National Institute of Mental Health (NIMH)
Leads: Friendi.fi Corporation

This content was sourced from clinicaltrials.gov