Anxiety DisordersNCT06364137
Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings
A study testing Teleo and Standard videoconferencing in people with Anxiety Disorders and Mood Disorders, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Mood Disorders
- What is being tested?
- Teleo and Standard videoconferencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Not under treatment with provider using Teleo platform
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform
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.
Read the 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.
- Conditions
- Anxiety Disorders, Mood Disorders
- Being tested
- Teleo, Standard videoconferencing
- Medical subject headings
- Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleoOther
Therapist-led psychotherapy sessions implemented within the Teleo virtual therapy platform.
Standard videoconferencingOther
Therapist-led psychotherapy sessions implemented in standard (non-Teleo) video platform
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard videoconferencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 1, 2, 3, 4
Secondary outcomes (3)
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. Scores range from 0-105, higher scores indicate 'better' outcome.
Measured: Post-intervention (at one month)
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. Scores range from 0-105, higher scores indicate 'better' outcome.
Measured: Post-intervention (at one month)
Attendance during Psychotherapy Sessions
Instances and frequency of appointment cancellations, appointment no-shows, and/or discontinuation of therapy will be recorded and analyzed.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jul 2024
- Primary completion15 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), MainSquare Co. (dba 'Teleo')
- Responsible party
- Principal investigator, David Hong, Stanford University
- Investigators
- David S Hong, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364137
- Sponsor's protocol ID
- 73203
- Other IDs
- R42MH136878
- Status last verified
- Sep 2025
- First submitted
- 8 Apr 2024
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engagement and Clinical Impact of the Teleo Virtual Therapy Platform
- ClinicalTrials.gov ID
- NCT06364137
- Acronym / sponsor ID
- 73203
- Conditions
- Anxiety Disorders, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), MainSquare Co. (dba 'Teleo')
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teleo | Experimental | Other: TeleoParticipants 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. |
| Standard videoconferencing | Active comparator | Other: Standard videoconferencingParticipants 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. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not under treatment with provider using Teleo platform
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleoTherapist-led psychotherapy sessions implemented within the Teleo virtual therapy platform. | Other | Teleo |
| Standard videoconferencingTherapist-led psychotherapy sessions implemented in standard (non-Teleo) video platform | Other | Standard videoconferencing |
Primary outcome
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.
3 secondary outcomes
My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores
Time frame: Post-intervention (at one month)
My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores
Time frame: Post-intervention (at one month)
Attendance during Psychotherapy Sessions
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Anxiety Disorders
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S Hong, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleo and Standard videoconferencing in people with Anxiety Disorders and Mood Disorders, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRIME-O Video Coding Score (time frame: Weeks 1, 2, 3, 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.