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NCT06364137 Clinical Trial

Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings - Pilot RCT

Anxiety Disorders Clinical Trial

Official title:
Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings - Pilot RCT

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06364137
Other study ID # 73203
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date June 30, 2025

Study information
Verified date April 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research study will examine engagement in telehealth for children undergoing psychotherapy. The study in Phase I entails a pilot randomized trial with a goal to enroll 42 families, examining patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing. Engagement will be assessed using well-established measures - PRIME-O (modified) video coding, MTT-Y/MTTCG and attendance data (sessions 1-4). Clinicians in the study will deliver therapy to clients for 4 sessions, providing opportunity to measure temporal sustainment of any engagement differences.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 42
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 14 Years
Eligibility Inclusion Criteria: - Patient ages 5-14 - Receiving psychotherapy with a licensed professional on the Teleo platform - Likely have at least 12 sessions remaining. - RCADS score > 65 Exclusion Criteria: - Not under treatment with provider using Teleo platform

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Stanford University Stanford California

Sponsors (3)
Lead Sponsor Collaborator
Stanford University MainSquare Co. (dba 'Teleo'), National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PRIME-O Video Coding Score Assess therapeutic engagement using modified PRIME-O total score, group scores, and individual item sub-scores. Weeks 1, 2, 3, 4
Secondary My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores Caregivers will complete modified MTT-CG questionnaire to measure engagement across dimensions of the REACH client engagement framework - Relationship, Expectancy, Attendance, Clarity, and Homework Post-intervention (at one month)
Secondary My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores Youth will complete questionnaires to measure self-reported engagement across dimensions of the REACH client engagement framework - Relationship, Expectancy, Attendance, Clarity, and Homework Post-intervention (at one month)
Secondary Attendance during Psychotherapy Sessions Instances and frequency of appointment cancellations, appointment no-shows, and/or discontinuation of therapy will be recorded and analyzed. One month
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