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Recruiting NCT07155707

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

No phase Interventional Anxiety Mood Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Teleo, Standard Videoconferencing.
Who it may be relevant to
Registry conditions: Anxiety, Mood Disorders. Basic parameters: 5 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • Other Teleo
    Therapist-led psychotherapy sessions implemented within the Teleo virtual therapy platform.
  • Other Standard Videoconferencing
    Therapist-led psychotherapy sessions implemented in standard (non-Teleo) video platform.

Primary outcome measures

  • Child Involvement Rating Scale (CIRS) [Time frame: Week 1]
Secondary outcome measures (6)
  • My Thoughts About Therapy Scale - Caregiver (MTT-CG) [Time frame: Weeks 1, 6 and 12]
  • My Thoughts About Therapy Scale - Youth (MTT-Y) [Time frame: Weeks 1, 6 and 12]
  • Revised Children's Anxiety and Depression Scale (RCADS) [Time frame: Baseline, Week 4, Week 12]
  • Rate of therapy session cancellations, no-shows, and treatment dropout [Time frame: Weeks 1-12]
  • Rate of clinician attrition [Time frame: Weeks 1-12]
  • Long-Term Cost of Care [Time frame: 1 year post-enrollment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 2 centers
  • Ohana Center for Child and Adolescent Behavioral Health — Monterey
  • Stanford University — Stanford

Identifiers

NCT: NCT07155707 · 80119 · R42MH136878

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗