- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06364137
Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings
Engagement and Clinical Impact of the Teleo Virtual Therapy Platform
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 (session 1), MTT-Y/MTTCG (sessions 1, 4) 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Receiving psychotherapy with a licensed professional on the Teleo platform
- Likely have at least 12 sessions remaining.
- Diagnosis of a mental health condition by a licensed clinician
Exclusion Criteria:
- Not under treatment with provider using Teleo platform
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teleo
Participants in this group will under therapy for 4 sessions using the Teleo virtual therapy video platform, sessions will be recorded and questionnaires and clinical data will be measured.
|
Therapist-led psychotherapy sessions implemented within the Teleo virtual therapy platform.
|
|
Active Comparator: Standard videoconferencing
Participants in this group will under therapy for 4 sessions using standard video platforms (e.g.
zoom or other publicly available product), sessions will be recorded and questionnaires and clinical data will be measured.
|
Therapist-led psychotherapy sessions implemented in standard (non-Teleo) video platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PRIME-O Video Coding Score
Time Frame: Weeks 1, 2, 3, 4
|
Assess therapeutic engagement using modified PRIME-O total score, group scores, and individual item sub-scores.
Scores range from 0-40, higher scores indicate 'better' outcome.
|
Weeks 1, 2, 3, 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance during Psychotherapy Sessions
Time Frame: One month
|
Instances and frequency of appointment cancellations, appointment no-shows, and/or discontinuation of therapy will be recorded and analyzed.
|
One month
|
|
My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores
Time Frame: Post-intervention (at one month)
|
Caregivers will complete modified MTT-CG questionnaire to measure engagement across dimensions of the REACH client engagement framework - Relationship, Expectancy, Attendance, Clarity, and Homework.
Scores range from 0-105, higher scores indicate 'better' outcome.
|
Post-intervention (at one month)
|
|
My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores
Time Frame: Post-intervention (at one month)
|
Youth will complete questionnaires to measure self-reported engagement across dimensions of the REACH client engagement framework - Relationship, Expectancy, Attendance, Clarity, and Homework.
Scores range from 0-105, higher scores indicate 'better' outcome.
|
Post-intervention (at one month)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David S Hong, MD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 73203
- R42MH136878 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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