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| ID | Type | Description | Link |
|---|---|---|---|
| R42MH136878 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| MainSquare Co. (dba 'Teleo') | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teleo | Other | Therapist-led psychotherapy sessions implemented within the Teleo virtual therapy platform. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 1, 6 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
- 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesse A Barrera, BA | Contact | 6193792399 | barreraj@stanford.edu | |
| David S Hong, MD | Contact | (650) 723-5511 | dshong@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| David S Hong, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohana Center for Child and Adolescent Behavioral Health | Not yet recruiting | Monterey | California | 93940 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D019964 | Mood Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Standard Videoconferencing | Other | Therapist-led psychotherapy sessions implemented in standard (non-Teleo) video platform. |
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| 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. | 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. | 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. | Weeks 1-12 |
| Rate of clinician attrition | Clinician attrition rates will be assessed via electronic health records (EHR). | 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. | 1 year post-enrollment |
| Stanford University | Recruiting | Stanford | California | 94305 | United States |
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