Health TrialsbyHealthPanel

Phase II: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings

ConditionsAnxietyMood Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-14
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Teleo

    Other intervention

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

  • Standard Videoconferencing

    Other intervention

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

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: TeleoExperimental treatment 1 intervention
Group B: Standard VideoconferencingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 1

Secondary outcomes

1

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.

Time frame
Weeks 1, 6 and 12
2

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.

Time frame
Weeks 1, 6 and 12
3

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.

Time frame
Baseline, Week 4, Week 12
4

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.

Time frame
Weeks 1-12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

MainSquare Co. (dba 'Teleo')

Collaborator

Source ClinicalTrials.gov
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