Assisted Identification and Navigation of Early Mental Health Symptoms in Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 358
- 试验地点
- 4
- 主要终点
- Percentage of youth initiating psychotherapy
研究概览
简要总结
The randomized, two-arm pragmatic trial will test the effectiveness of offering 6-months of telephonic support from a mental health (MH) navigator to promote early access, engagement, coordination, and personalization of mental health treatment and services for children naïve to such treatments and services, and who are identified as being at risk for behavioral health concerns.
The model includes: (a) automated identification of early symptoms for children meeting criteria for behavioral health problems using a previously developed Natural Language Processing (NLP) program and predictive algorithm; (b) standardized instruments for assessment and diagnosis of mental health disorders (c) 30 minute assessment appointments with a study psychologist (d) creation of an Epic "reporting workbench" and Epic "smart form" to facilitate the outreach, monitoring and follow-up of families/children by the MH navigator; (e) use of MH Navigators (e.g., clinical social workers) to conduct family outreach, and coordination with and between clinicians; and (f) the offer of one to four clinic-to-home videoconferencing brief therapy sessions to bridge families/children unwilling or unable to access in-person MH services.
详细描述
The specific aim of the pragmatic trial is to:
Test a MH navigator model to promote early access, engagement, coordination, and personalization of mental health treatment and services as soon as early symptoms of mental health problems are detected in children.
The navigator model and implementation to be tested include:
- Automated identification of early symptoms for children meeting study criteria to populate an Epic "reporting workbench" for eligibility screening and randomization;
- Virtual collection of self-reported, standardized assessment scores;
- Psychologists interpreting assessment scores and providing feedback to families and PCPs;
- Trained clinicians serving as MH "navigators" to conduct family outreach, engage them in MH care, and coordinate with and between clinicians for up to 6-months;
- An Epic reporting workbench for MN navigators to manage their active panel of patients;
- An Epic "smart form" to facilitate the MH navigator's outreach, monitoring and follow-up to their panel;
- Up to 4 video-based behavioral health sessions with the MH navigator, as needed, while barriers to initiation of ongoing mental health services can be explored and addressed over the 6-month period.
This study will employ an encouragement trial design, an alternative to a traditional RCT design. Guardians of randomized youth are offered the opportunity to receive additional services (navigation, FAST brief therapy sessions), but allowed to choose whether to receive the services. That is, acceptance of or adherence to the offered study services is not a condition of participation. Whether or not guardians choose to accept intervention services from the beginning is a measure of the effectiveness of the program. Guardians who decline the additional services (navigation, FAST sessions) must remain in the intervention arm in order to measure the effectiveness of the intervention without bias. This allows an intent-to-treat comparison between arms. That is, patients remain enrolled in the study regardless of the navigators' ability to contact the family by phone or the family's perceived need for or willingness to accept or participate in study-based services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 4 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control Arm
Data will be collected at baseline and 6-month follow-up from the standardized instruments and automated sources for all eligible subjects randomized to the control arm.
Families who agree to participate will first be offered a formal assessment in order to ascertain the primary mental health diagnosis and any co-occurring mental health disorders. After completing the online parent/guardian self-assessment, parents/guardians will meet for 30 minutes with a mental health clinician to review their answers, discuss diagnoses, and refer the family back to their primary care provider.
Study clinicians will document clinically relevant information from their assessment in a telephone encounter and route these to the child's KP primary care provider in Epic as well as the site navigator.
Control arm participants do not receive navigation.
干预措施: Control Arm (Behavioral)
Navigation Arm
6-months of telephonic support from a mental health (MH) navigator to promote early access, engagement, coordination, and personalization of mental health treatment and services as soon as early symptoms of mental health problems are detected in children.
The navigator model and implementation to be tested include:
- Automated identification of early symptoms for children
- Virtual collection of self-reported, standardized assessment scores
- Psychologists interpreting assessment scores and providing feedback to families and PCPs
- Trained clinicians serving as MH "navigators" to conduct family outreach, engage them in MH care, and coordinate with and between clinicians for up to 6-months
- Up to 4 video-based behavioral health sessions with the MH navigator, as needed, while barriers to initiation of ongoing mental health services can be explored and addressed over the 6-month period.
干预措施: Navigation Arm (Behavioral)
结局指标
主要结局
Percentage of youth initiating psychotherapy
时间窗: 6 months from randomization date
Youth initiating psychotherapy divided by all youth enrolled in the study arm
次要结局
- Percentage of youth attending at least 4 psychotherapy sessions(6 months from randomization date)
