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

NCT07155707 | Not Yet Recruiting

• 2 other identifiers: 80119R42MH136878
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anxiety; Mood Disorders

Keywords

Teletherapy; Therapeutic Engagement; Anxiety; Depression; Youth Mental Health; Digital Mental Health

Outcome Measures

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.

  Week 1

Secondary Outcomes (6)

• My Thoughts About Therapy Scale - Caregiver (MTT-CG)

  Weeks 1, 6 and 12

• My Thoughts About Therapy Scale - Youth (MTT-Y)

  Weeks 1, 6 and 12

• Revised Children's Anxiety and Depression Scale (RCADS)

  Baseline, Week 4, Week 12

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

  Weeks 1-12

• Rate of clinician attrition

  Weeks 1-12

Study Arms (2)

Teleo

EXPERIMENTAL

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

Standard Videoconferencing

ACTIVE COMPARATOR

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

Teleo OTHER

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

Teleo

Standard Videoconferencing OTHER

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

Standard Videoconferencing

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Mental Health (NIMH): collaborator
• MainSquare Co. (dba 'Teleo'): collaborator

Study Sites (2)

Ohana Center for Child and Adolescent Behavioral Health

Monterey, California, 93940, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• David S Hong, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse A Barrera, BA

CONTACT

6193792399; barreraj@stanford.edu

David S Hong, MD

CONTACT

(650) 723-5511; dshong@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 4, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)