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RecruitingNCT07155707Updated Jun 29, 2026

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

An interventional study of Teleo and Standard Videoconferencing in Anxiety and Mood Disorders, sponsored by Stanford University. Recruiting at 2 sites in United States. Open to participants aged 5 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

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

Phase
Not applicable
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
5 Years to 14 Years
Sex
All
01

Study summary

This Phase II trial will examine engagement in telehealth for children undergoing psychotherapy. Specifically, the trial will 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

This study aims to examine the impact of tailored telehealth psychotherapy environments on clinical outcomes in the context of pediatric mental health treatment. Researchers will conduct a full-scale RCT with 156 families to assess how Teleo compares to standard video conferencing (e.g., Zoom) on a range of clinical metrics, including cancellation/no-show rates, clinician satisfaction, duration of treatment, need for medication, and symptoms of anxiety and depression.

02

Conditions studied

  • Anxiety
  • Mood Disorders

Keywords

  • Teletherapy
  • Therapeutic Engagement
  • Anxiety
  • Depression
  • Youth Mental Health
  • Digital Mental Health
03

Who can participate

Ages eligible
5 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with a mood and/or anxiety disorder
  • Have proficiency to participate in psychotherapy in English
  • Scheduled to begin therapy at one of the study sites
  • RCADS score > 65

Exclusion criteria

Exclusion Criteria:

- Comorbid diagnosis of intellectual disability, autism spectrum disorder, psychotic disorders, high-risk suicidal behaviors requiring immediate hospitalization, substance use disorders, or other physical or mental condition that would prohibit them from engaging in telehealth settings.

04

Study design

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

Study arms

  • Experimental
    Teleo

    Participants in this arm will undergo therapy for 12 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 undergo therapy for 12 sessions using standard video platforms (e.g. Zoom or Microsoft Teams). 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.

05

What researchers measure

Primary outcomes

  1. Child Involvement Rating Scale (CIRS)

    Observational coding questionnaire designed to assess child engagement in therapy. Consists of 6 items (4 positively-framed, 2 negatively-framed), each on a 0-5 scale. To calculate a summary score, the two negatively-framed items are reverse scored and scores on all six items are averaged. Summary scores range from 0-5, with higher scores representing greater child engagement in therapy.

    Time frame: Week 1

Secondary outcomes

  1. My Thoughts About Therapy Scale - Caregiver (MTT-CG)

    Caregivers will complete the MTT-GC questionnaire to measure their child's engagement in psychotherapy 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: Weeks 1, 6 and 12

  2. My Thoughts About Therapy Scale - Youth (MTT-Y)

    Youth will complete questionnaires to measure self-reported engagement in psychotherapy 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: Weeks 1, 6 and 12

  3. Revised Children's Anxiety and Depression Scale (RCADS)

    Caregivers will complete questionnaire to assess child participants' symptoms of anxiety and mood disorders across six dimensions: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). Standardized T-scores will be calculated for each subscale and for the overall scale. T-scores range from 30-90, with lower scores representing better outcomes.

    Time frame: Baseline, Week 4, Week 12

  4. Rate of therapy session cancellations, no-shows, and treatment dropout

    Participants' electronic health records (EHR) will be used to track session cancellations, no-shows, and treatment dropout.

    Time frame: Weeks 1-12

  5. Rate of clinician attrition

    Clinician attrition rates will be assessed via electronic health records (EHR).

    Time frame: Weeks 1-12

  6. Long-Term Cost of Care

    Treatment duration and medication use will be assessed over 1 year following participants' enrollment in the study, and used to calculate differences in average long-term cost of care between the study arms.

    Time frame: 1 year post-enrollment

06

Study locations

1 of 2 sites recruiting
  • Ohana Center for Child and Adolescent Behavioral Health
    Monterey, California 93940, United States
    Not yet recruiting
  • Stanford University
    Stanford, California 94305, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07155707
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
Sep 4, 2025
Start date
Jun 24, 2026
Primary completion
Sep 15, 2027 (estimated)
Completion
Sep 15, 2027 (estimated)
Last update
Jun 29, 2026

Study contacts

Jesse A Barrera, BA
Contact
barreraj@stanford.edu
6193792399
David S Hong, MD
Contact
dshong@stanford.edu
(650) 723-5511
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 ↗

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