AnxietyNCT07155707
Phase II: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings
A study testing Teleo and Standard Videoconferencing in people with Anxiety and Mood Disorders, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Anxiety, Mood Disorders
- What is being tested?
- Teleo and Standard Videoconferencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2026to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Who may be able to join
- 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
- RCADS score > 65
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Ohana Center for Child and Adolescent Behavioral Health
Monterey, California, 93940
- Recruiting
Stanford University
Stanford, California, 94305
David S Hong, MD, 650-724-2939, dshong@stanford.edu
About this study
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.
Read the 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.
- Conditions
- Anxiety, Mood Disorders
- Being tested
- Teleo, Standard Videoconferencing
- Keywords
- Teletherapy, Therapeutic Engagement, Anxiety, Depression, Youth Mental Health, Digital Mental Health
- Medical subject headings
- Anxiety Disorders, Mood Disorders, Depression
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 arm will undergo therapy for 12 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 undergo therapy for 12 sessions using standard video platforms (e.g. Zoom or Microsoft Teams). 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.
Child Involvement Rating Scale (CIRS)
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.
Measured: Week 1
Secondary outcomes (6)
My Thoughts About Therapy Scale - Caregiver (MTT-CG)
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.
Measured: Weeks 1, 6 and 12
My Thoughts About Therapy Scale - Youth (MTT-Y)
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.
Measured: Weeks 1, 6 and 12
Revised Children's Anxiety and Depression Scale (RCADS)
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.
Measured: Baseline, Week 4, Week 12
Rate of therapy session cancellations, no-shows, and treatment dropout
Participants' electronic health records (EHR) will be used to track session cancellations, no-shows, and treatment dropout.
Measured: Weeks 1-12
Rate of clinician attrition
Clinician attrition rates will be assessed via electronic health records (EHR).
Measured: Weeks 1-12
Long-Term Cost of Care
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.
Measured: 1 year post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start24 Jun 2026
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- 156 participants (estimated)
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
- NCT07155707
- Sponsor's protocol ID
- 80119
- Other IDs
- R42MH136878
- Status last verified
- Jun 2026
- First submitted
- 27 Aug 2025
- Last updated
- 29 Jun 2026
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings
- ClinicalTrials.gov ID
- NCT07155707
- Acronym / sponsor ID
- 80119
- Conditions
- Anxiety, Mood Disorders
- Keywords
- Teletherapy, Therapeutic Engagement, Anxiety, Depression, Youth Mental Health, Digital Mental Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), MainSquare Co. (dba 'Teleo')
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 4 Sep 2025 (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.
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 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 arm will undergo therapy for 12 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 undergo therapy for 12 sessions using standard video platforms (e.g. Zoom or Microsoft Teams). Sessions will be recorded and questionnaires and clinical data will be measured. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
- RCADS score > 65
Key exclusion criteria (1 listed)
- 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.
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
Child Involvement Rating Scale (CIRS)
Time frame: 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.
6 secondary outcomes
My Thoughts About Therapy Scale - Caregiver (MTT-CG)
Time frame: Weeks 1, 6 and 12
My Thoughts About Therapy Scale - Youth (MTT-Y)
Time frame: Weeks 1, 6 and 12
Revised Children's Anxiety and Depression Scale (RCADS)
Time frame: Baseline, Week 4, Week 12
Rate of therapy session cancellations, no-shows, and treatment dropout
Time frame: Weeks 1-12
Rate of clinician attrition
Time frame: Weeks 1-12
Long-Term Cost of Care
Time frame: 1 year post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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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.
David S Hong, MD principal investigator
Stanford University
2 sites 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 and Mood Disorders, run by Stanford University at 2 sites 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 4 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: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesse A Barrera, BA (6193792399, barreraj@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Involvement Rating Scale (CIRS) (time frame: Week 1). 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 29 Jun 2026.