CClinicalTrials.gg
CompletedNCT06364137Updated Sep 23, 2025

Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings

An interventional study of Teleo and Standard videoconferencing in Anxiety Disorders and Mood Disorders, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 5 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
5 Years to 14 Years
Sex
All
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Study summary

The research study will examine engagement in telehealth for children undergoing psychotherapy. Specifically, the pilot trial will examine examine patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.

Read the detailed description

The research study will examine engagement in telehealth for children undergoing psychotherapy. The study in Phase I entails a pilot randomized trial with a goal to enroll 42 families, examining patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.

Engagement will be assessed using well-established measures - PRIME-O (modified) video coding (session 1), MTT-Y/MTTCG (sessions 1, 4) and attendance data (sessions 1-4). Clinicians in the study will deliver therapy to clients for 4 sessions, providing opportunity to measure temporal sustainment of any engagement differences.

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Conditions studied

  • Anxiety Disorders
  • Mood Disorders
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In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 41 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Receiving psychotherapy with a licensed professional on the Teleo platform
  • Likely have at least 12 sessions remaining.
  • Diagnosis of a mental health condition by a licensed clinician

Exclusion criteria

Exclusion Criteria:

  • Not under treatment with provider using Teleo platform
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Teleo

    Participants in this group will under therapy for 4 sessions using the Teleo virtual therapy video platform, sessions will be recorded and questionnaires and clinical data will be measured.

    Other: Teleo

  • Active comparator
    Standard videoconferencing

    Participants in this group will under therapy for 4 sessions using standard video platforms (e.g. zoom or other publicly available product), sessions will be recorded and questionnaires and clinical data will be measured.

    Other: Standard videoconferencing

Interventions

  • OtherTeleo

    Therapist-led psychotherapy sessions implemented within the Teleo virtual therapy platform.

  • OtherStandard videoconferencing

    Therapist-led psychotherapy sessions implemented in standard (non-Teleo) video platform

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What researchers measure

Primary outcomes

  1. PRIME-O Video Coding Score

    Assess therapeutic engagement using modified PRIME-O total score, group scores, and individual item sub-scores. Scores range from 0-40, higher scores indicate 'better' outcome.

    Time frame: Weeks 1, 2, 3, 4

Secondary outcomes

  1. My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores

    Caregivers will complete modified MTT-CG questionnaire to measure engagement across dimensions of the REACH client engagement framework - Relationship, Expectancy, Attendance, Clarity, and Homework. Scores range from 0-105, higher scores indicate 'better' outcome.

    Time frame: Post-intervention (at one month)

  2. My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores

    Youth will complete questionnaires to measure self-reported engagement across dimensions of the REACH client engagement framework - Relationship, Expectancy, Attendance, Clarity, and Homework. Scores range from 0-105, higher scores indicate 'better' outcome.

    Time frame: Post-intervention (at one month)

  3. Attendance during Psychotherapy Sessions

    Instances and frequency of appointment cancellations, appointment no-shows, and/or discontinuation of therapy will be recorded and analyzed.

    Time frame: One month

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Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
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References and documents

Study documents

  • Informed consent form · Mar 31, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06364137
Lead sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH), MainSquare Co. (dba 'Teleo')
Responsible party
David Hong (Associate Professor of Psychiatry and Behavioral Sciences, Stanford University) — Principal investigator
First posted
Apr 15, 2024
Start date
Jul 1, 2024
Primary completion
Aug 15, 2025
Completion
Sep 15, 2025
Last update
Sep 23, 2025

Study contacts

David S Hong, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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