Families Moving Forward (FMF) Connect Pro for Mental Health Providers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Reach: proportion of agencies who accept introductory webinar presentation
研究概览
简要总结
The goal of this clinical trial is to test a new provider-assisted version of the caregiver Families Moving Forward (FMF) Connect app ("FMF Connect Pro") with mental health providers in the United States. In FMF Connect Pro, mental health providers learn to do routine screening for prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (FASD), and support families in using the FMF Connect caregiver app.
Two different training methods will be compared with a waitlist group in this study. The first training method involves 13-sessions of tele-mentoring using an Extension of Community Healthcare Outcomes (ECHO) approach. The second training method involves a self-directed approach in which providers will access similar content in any asynchronous format on a website.
The main questions this study aims to answer are:
- What is the proportion of agencies and providers who accept and participate in the clinical trial (Reach)?
- Do study groups differ on provider outcome measures of Effectiveness (clients screened/diagnosed), Adoption (provider change in knowledge, self-efficacy), Implementation (practice change, FMF Connect Pro Dashboard usage), and Maintenance of FASD-informed care practice change?
All mental health providers in the study will complete online assessments at study entry, 6 months, and 12 months.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Licensed mental health provider or supervised trainee
- •Employed by a community mental agency or in private practice
- •provides mental health services to children ages 3 to 12 or their families
- •provides services in the United States
- •Fluency in English
- •Access to the internet
排除标准
- •Provides services outside of the United States
- •Does not provide mental health services to children ages 3 to 12
研究组 & 干预措施
FMF (Families Moving Forward) Connect Pro with ECHO implementation
Mental health providers are trained in FMF Connect Pro with ECHO (Extension of Community Healthcare Outcomes) tele-mentoring. FMF Connect Pro teaches mental health providers how to do routine screening of prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (FASD), and support caregivers in using the FMF Connect app. The FMF Connect Pro Dashboard organizes intervention content for providers and includes tools for client progress monitoring. In this arm, providers receive training in FMF Connect Pro through 13 bi-weekly ECHO tele-mentoring sessions. Each ECHO session involves brief didactic presentations by Hub Team members on FASD-informed care principles and FMF Connect content and case-based discussions and recommendations by Spoke Sites.
干预措施: FMF (Families Moving Forward) Connect Pro (Behavioral)
FMF (Families Moving Forward) Connect Pro with ECHO implementation
Mental health providers are trained in FMF Connect Pro with ECHO (Extension of Community Healthcare Outcomes) tele-mentoring. FMF Connect Pro teaches mental health providers how to do routine screening of prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (FASD), and support caregivers in using the FMF Connect app. The FMF Connect Pro Dashboard organizes intervention content for providers and includes tools for client progress monitoring. In this arm, providers receive training in FMF Connect Pro through 13 bi-weekly ECHO tele-mentoring sessions. Each ECHO session involves brief didactic presentations by Hub Team members on FASD-informed care principles and FMF Connect content and case-based discussions and recommendations by Spoke Sites.
干预措施: ECHO (Extension of Community Healthcare Outcomes) implementation. (Behavioral)
FMF (Families Moving Forward) Connect Pro with Self-directed materials
Mental health providers are trained in FMF Connect Pro with self-directed materials. FMF Connect Pro teaches mental health providers how to do routine screening of prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (FASD), and support caregivers in using the FMF Connect app. The FMF Connect Pro Dashboard organizes intervention content for providers and includes tools for client progress monitoring. In this arm, mental health providers will access similar didactic content as ECHO participants, but in an asynchronous format on the FMF Connect Pro Dashboard. This will include pre-recorded videos, activities, and additional resources for further learning.
干预措施: FMF (Families Moving Forward) Connect Pro (Behavioral)
FMF (Families Moving Forward) Connect Pro with Self-directed materials
Mental health providers are trained in FMF Connect Pro with self-directed materials. FMF Connect Pro teaches mental health providers how to do routine screening of prenatal alcohol exposure, diagnose fetal alcohol spectrum disorders (FASD), and support caregivers in using the FMF Connect app. The FMF Connect Pro Dashboard organizes intervention content for providers and includes tools for client progress monitoring. In this arm, mental health providers will access similar didactic content as ECHO participants, but in an asynchronous format on the FMF Connect Pro Dashboard. This will include pre-recorded videos, activities, and additional resources for further learning.
干预措施: Self-Directed Learning implementation. (Behavioral)
Waitlist Comparison Group
The waitlist comparison group will receive FMF Connect Pro via Self-directed materials after completing assessments at the 6-month timepoint.
结局指标
主要结局
Reach: proportion of agencies who accept introductory webinar presentation
时间窗: 3 months prior to baseline
Research staff will document the number of mental health agencies who agree to participate in the introductory webinar presentation out of the total number approached.
Reach: proportion of mental health providers who enroll in the study
时间窗: 3 months prior to baseline
Research staff will document the number of mental health providers who enroll in the study out of the total number of providers who attend the introductory webinar at recruitment.
Reach: proportion of mental health providers who complete data collection
时间窗: baseline to 6 months
Research staff will document the number of mental health providers who complete follow-up data collection out of the total number of providers who enrolled in the study.
Adoption: Number of Self-Directed Sessions Completed
时间窗: 6 months
Participant completion of each self-directed learning module will be measured for the FMF Connect Pro with Self-Directed implementation group. There are 13 total modules.
Implementation: Change in FASD-informed practice
时间窗: baseline to 6 months
Participant practice change will be assessed using the FASD- Informed Care Practice Change scale. This measure is aligned with specific FASD-informed care behaviors taught in ECHO and self-directed versions of FMF Connect Pro. This measure includes 15 items rated on a 5-point scale, with scores ranging from 15 to 75. Higher scores reflect clinical practice more consistent with FASD-informed care.
Effectiveness: Percentage of clients screened for prenatal alcohol exposure
时间窗: baseline to 1 year
Mental health providers will be asked as part of the Practice Change survey at each time point the percentage of clients they screen for prenatal alcohol exposure.
Adoption: Change in Provider FASD-Informed Care Knowledge
时间窗: baseline to 6 months
Participant knowledge will be assessed using the Knowledge of FASD-Informed Care survey. This survey assesses the content and principles of FASD-informed care. The survey has 30 questions, with each question worth 1 point. Scores range from 0 to 30, with higher scores reflecting greater knowledge.
Effectiveness: Number of clients diagnosed with a fetal alcohol spectrum disorder
时间窗: baseline to 1 year
Mental health providers will be asked at each time point the number of clients they have diagnosed with a fetal alcohol spectrum disorder (using the DSM-5 Neurodevelopmental Disorder Associated with Prenatal Alcohol Exposure criteria).
Adoption: Number of ECHO Sessions Completed
时间窗: 6 months
Participant attendance at each ECHO session will be measured for FMF Connect Pro with ECHO implementation group. There are 13 total sessions.
Maintenance: Change in FASD-informed practice
时间窗: 6 months to 1 year
Participant practice change will be assessed using the FASD- Informed Care Practice Change scale. This measure is aligned with specific FASD-informed care behaviors taught in ECHO and self-directed versions of FMF Connect Pro. This measure includes 15 items rated on a 5-point scale, with scores ranging from 15 to 75. Higher scores reflect clinical practice more consistent with FASD-informed care.
Effectiveness: Number of clients enrolled in FMF Connect Pro Dashboard
时间窗: baseline to 1 year
FMF Connect Pro Dashboard analytics will be examined to assess the number of clients providers have enrolled in FMF Connect.
Adoption: Change in FASD-Informed Care Self-Efficacy
时间窗: baseline to 6 months
Participant self-efficacy will be assessed using the FASD-Informed Care Self-Efficacy scale. This scale assesses provider self-efficacy in specific FASD- informed care skills in mental health settings. The measure includes 12 items. Items are rated on a 6-point Likert scale from 1 "no confidence" to 6 "highly confident/expert." Scores range from 12 to 72, with higher scores reflecting greater confidence or self-efficacy.
Implementation and Maintenance: FMF Connect Pro Dashboard usage
时间窗: baseline to 1 year
FMF Connect Pro Dashboard analytics will be extracted to measure the number of times providers accessed the website.
次要结局
- Contextual determinants on outcomes: Mean score on the Theoretical Domains Framework (TDF) survey(baseline to 1 year)
研究者
Christie Petrenko
Professor
University of Rochester