NCT06364137

Brief Summary

The research study will examine engagement in telehealth for children undergoing psychotherapy. Specifically, the pilot trial will examine examine patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

April 8, 2024

Last Update Submit

September 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • PRIME-O Video Coding Score

    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 Outcomes (3)

  • My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores

    Post-intervention (at one month)

  • My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores

    Post-intervention (at one month)

  • Attendance during Psychotherapy Sessions

    One month

Study Arms (2)

Teleo

EXPERIMENTAL

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.

Other: Teleo

Standard videoconferencing

ACTIVE COMPARATOR

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.

Other: Standard videoconferencing

Interventions

TeleoOTHER

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

Teleo

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

Standard videoconferencing

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Not under treatment with provider using Teleo platform

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Anxiety DisordersMood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • David S Hong, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 15, 2024

Study Start

July 1, 2024

Primary Completion

August 15, 2025

Study Completion

September 15, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations