Phase II: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 4
- 主要终点
- Child Involvement Rating Scale (CIRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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.
研究组 & 干预措施
Teleo
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.
干预措施: Teleo (Other)
Standard Videoconferencing
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.
干预措施: Standard Videoconferencing (Other)
结局指标
主要结局
Child Involvement Rating Scale (CIRS)
时间窗: 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.
Child Involvement Rating Scale (CIRS)
时间窗: 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.
次要结局
- My Thoughts About Therapy Scale - Caregiver (MTT-CG)(Weeks 1, 6 and 12)
- My Thoughts About Therapy Scale - Youth (MTT-Y)(Weeks 1, 6 and 12)
- Revised Children's Anxiety and Depression Scale (RCADS)(Baseline, Week 4, Week 12)
- My Thoughts About Therapy Scale - Caregiver (MTT-CG)(Weeks 1, 6 and 12)
- My Thoughts About Therapy Scale - Youth (MTT-Y)(Weeks 1, 6 and 12)
- Revised Children's Anxiety and Depression Scale (RCADS)(Baseline, Week 4, Week 12)
- Rate of therapy session cancellations, no-shows, and treatment dropout(Weeks 1-12)
- Rate of clinician attrition(Weeks 1-12)
- Long-Term Cost of Care(1 year post-enrollment)
研究者
David Hong
Associate Professor of Psychiatry and Behavioral Sciences
Stanford University