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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mood Disorders; Anxiety
• Intervention / Treatment: Other: Teleo; Other: Standard Videoconferencing

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.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesse A Barrera, BA; Phone Number: 6193792399; Email: barreraj@stanford.edu
• Study Contact Backup: Name: David S Hong, MD; Phone Number: (650) 723-5511; Email: dshong@stanford.edu

Study Locations

• United States
  • California
    • Monterey, California, United States, 93940
      • Ohana Center for Child and Adolescent Behavioral Health
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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:

- 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Therapist-led psychotherapy sessions implemented within the Teleo virtual therapy platform.
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; Therapist-led psychotherapy sessions implemented in standard (non-Teleo) video platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 1, 6 and 12
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.	Weeks 1, 6 and 12
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.	Baseline, Week 4, Week 12
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.	1 year post-enrollment
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.	Weeks 1-12
Rate of clinician attrition	Clinician attrition rates will be assessed via electronic health records (EHR).	Weeks 1-12

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Mental Health (NIMH); MainSquare Co. (dba 'Teleo')
• Investigators: Principal Investigator: David S Hong, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: August 27, 2025
• First Submitted That Met QC Criteria: August 27, 2025
• First Posted (Estimated): September 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Teletherapy; Youth Mental Health; Digital Mental Health; Therapeutic Engagement
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Mood Disorders
• Other Study ID Numbers: 80119; R42MH136878 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No