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

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Mood Disorders

• Registration Number: NCT07155707
• Lead Sponsor: Stanford University

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.

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-27
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Study Start: 2025-09-15
• Primary Completion: 2027-09-15
• Study Completion: 2027-09-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 156

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Child Involvement Rating Scale (CIRS)	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 Outcome Measures

Name	Time	Method
My Thoughts About Therapy Scale - Caregiver (MTT-CG)	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.
My Thoughts About Therapy Scale - Youth (MTT-Y)	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.
Revised Children's Anxiety and Depression Scale (RCADS)	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.
Therapy Attendance	Weeks 1-12	Participants' electronic health records (EHR) will be used to track session cancellations, no-shows, and treatment dropout.
Clinician Attrition	Weeks 1-12	Clinician attrition rates will be assessed via electronic health records (EHR).
Long-Term Cost of Care	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.

Trial Locations

Locations (2)

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

Stanford University; 🇺🇸 Stanford, California, United States