Anxiety, Mood Disorders
Conditions
Keywords
Teletherapy, Therapeutic Engagement, Anxiety, Depression, Youth Mental Health, Digital Mental Health
Brief 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.
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.
Interventions
OTHERTeleo
Therapist-led psychotherapy sessions implemented within the Teleo virtual therapy platform.
Therapist-led psychotherapy sessions implemented in standard (non-Teleo) video platform.
Sponsors
Stanford University
National Institute of Mental Health (NIMH)
MainSquare Co. (dba 'Teleo')
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Involvement Rating Scale (CIRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revised Children's Anxiety and Depression Scale (RCADS) | Baseline, Week 4, Week 12 | 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. |
| Rate of therapy session cancellations, no-shows, and treatment dropout | Weeks 1-12 | Participants' electronic health records (EHR) will be used to track session cancellations, no-shows, and treatment dropout. |
| My Thoughts About Therapy Scale - Youth (MTT-Y) | Weeks 1, 6 and 12 | 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. |
| Long-Term Cost of Care | 1 year post-enrollment | 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. |
| My Thoughts About Therapy Scale - Caregiver (MTT-CG) | Weeks 1, 6 and 12 | 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. |
| Rate of clinician attrition | Weeks 1-12 | Clinician attrition rates will be assessed via electronic health records (EHR). |
Countries
United States
Contacts
CONTACTJesse A Barrera, BA
CONTACTDavid S Hong, MD
PRINCIPAL_INVESTIGATORDavid S Hong, MD
Stanford University
Outcome results
None listed