Families Moving Forward (FMF) Connect Pro for Mental Health Providers
ConditionFetal Alcohol Spectrum Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Provides services outside of the United States
Does not provide mental health services to children ages 3 to 12
Trial design
Design model
Parallel
Treatments tested in this trial
FMF (Families Moving Forward) Connect Pro
BehavioralFMF 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
ECHO (Extension of Community Healthcare Outcomes) implementation.
BehavioralMental 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.
Self-Directed Learning implementation.
BehavioralMental 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.
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: FMF (Families Moving Forward) Connect Pro with ECHO implementationExperimental treatment 2 interventions
Group B: FMF (Families Moving Forward) Connect Pro with Self-directed materialsExperimental treatment 2 interventions
Group C: Waitlist Comparison GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Reach: proportion of agencies who accept introductory webinar presentation
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.
Time frame
3 months prior to baseline2
Reach: proportion of mental health providers who enroll in the study
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.
Time frame
3 months prior to baseline3
Reach: proportion of mental health providers who complete data collection
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.
Time frame
baseline to 6 months4
Effectiveness: Percentage of clients screened for prenatal alcohol exposure
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.
Time frame
baseline to 1 yearSecondary outcomes
1
Contextual determinants on outcomes: Mean score on the Theoretical Domains Framework (TDF) survey
Providers will complete an adapted version of the Theoretical Domains Framework (TDF) survey to assess possible barriers and facilitators impacting implementation of the intervention. The survey includes 27 items. Responses are scored from 1(strongly disagree) to 7 (strongly agree). Scores range from 27 to 189, with higher scores reflecting greater agreement.
Time frame
baseline to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov