NCT05960461 · University of Rochester
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
FMF (Families Moving Forward) Connect Pro
FMF Connect Pro is a program supported by mental health providers to increase access to care for children (ages 3 to 12) with fetal alcohol spectrum disorders (FASD) and their families. FMF Connect Pro teaches and supports providers in 3 main activities: 1. Routine screening of prenatal alcohol exposure (PAE) 2. Apply DSM-5 diagnostic criteria for "Neurodevelopmental Disorder Associated with Prenatal Alcohol Exposure (ND-PAE)" 3. Support caregivers using the FMF Connect app FMF Connect Pro involves a Provider Dashboard with several main sections: * Learning - includes content and additional resources to support providers in learning how to screen PAE, diagnose ND-PAE, and support families using the FMF Connect app. * Tools and Resources - includes: screening, diagnostic, and documentation templates; app tip sheets; workbooks; supporting articles, websites, and other resources * Clients - providers can track clients' progress using the FMF Connect app
BEHAVIORAL
ECHO (Extension of Community Healthcare Outcomes) implementation.
Mental health providers participate in a 13-session tele-mentoring training program using the ECHO (Extension of Community Healthcare Outcomes) approach. Each session involves a brief didactic presentation and case-based learning using de-identified cases shared by participants. The curriculum teaches providers how to do FMF Connect Pro.
BEHAVIORAL
Self-Directed Learning implementation.
Mental health providers complete 13 learning modules asynchronously on the FMF Connect Pro Dashboard. These modules include pre-recorded didactic content, brief exercises to assess learning, and additional resources. The curriculum teaches providers how to do FMF Connect Pro.
Primary outcome measures
Reach: proportion of agencies who accept introductory webinar presentation
Time frame: 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
Time frame: 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
Time frame: 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.
Effectiveness: Percentage of clients screened for prenatal alcohol exposure
Time frame: 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.
Effectiveness: Number of clients diagnosed with a fetal alcohol spectrum disorder
Time frame: 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).
Effectiveness: Number of clients enrolled in FMF Connect Pro Dashboard
Time frame: 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: Number of ECHO Sessions Completed
Time frame: 6 months
Participant attendance at each ECHO session will be measured for FMF Connect Pro with ECHO implementation group. There are 13 total sessions.
Adoption: Number of Self-Directed Sessions Completed
Time frame: 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.
Adoption: Change in Provider FASD-Informed Care Knowledge
Time frame: 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.
Adoption: Change in FASD-Informed Care Self-Efficacy
Time frame: 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: Change in FASD-informed practice
Time frame: 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.
Maintenance: Change in FASD-informed practice
Time frame: 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.
Implementation and Maintenance: FMF Connect Pro Dashboard usage
Time frame: baseline to 1 year
FMF Connect Pro Dashboard analytics will be extracted to measure the number of times providers accessed the website.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Provides services outside of the United States
- Does not provide mental health services to children ages 3 to 12
Where
- Rochester, New York
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2025 · Source of record for eligibility and locations