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NCT Number: NCT07155707

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Mood Disorders

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohana Center for Child and Adolescent Behavioral Health, Monterey, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teleo

Other

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

Standard Videoconferencing

Other

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

Primary outcomes

  1. Child Involvement Rating Scale (CIRS)

    Time frame: Week 1

    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.

Secondary outcomes

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

    Time frame: Weeks 1, 6 and 12

    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.

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

    Time frame: Weeks 1, 6 and 12

    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.

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

    Time frame: Baseline, Week 4, Week 12

    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.

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

    Time frame: Weeks 1-12

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

  5. Rate of clinician attrition

    Time frame: Weeks 1-12

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

  6. Long-Term Cost of Care

    Time frame: 1 year post-enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

David S Hong, MD

CONTACT

[email protected]

(650) 723-5511

Jesse A Barrera, BA

CONTACT

[email protected]

6193792399

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • MainSquare Co. (dba 'Teleo')
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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