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

NCT ID: NCT07155707

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2027-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Teleo

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Standard Videoconferencing

Intervention Type OTHER

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

Interventions

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Teleo

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

Intervention Type OTHER

Standard Videoconferencing

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

MainSquare Co. (dba 'Teleo')

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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David Hong

Associate Professor of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Hong, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Ohana Center for Child and Adolescent Behavioral Health

Monterey, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Central Contacts

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Jesse A Barrera, BA

Role: CONTACT

6193792399

David S Hong, MD

Role: CONTACT

(650) 723-5511

Other Identifiers

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R42MH136878

Identifier Type: NIH

Identifier Source: secondary_id

View Link

80119

Identifier Type: -

Identifier Source: org_study_id

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