Families Moving Forward (FMF) Connect Pro for Mental Health Providers

University of Rochester

Status: Enrolling

Conditions: Fetal Alcohol Spectrum Disorders

Treatments: Behavioral: ECHO (Extension of Community Healthcare Outcomes) implementation.; Behavioral: Self-Directed Learning implementation.; Behavioral: FMF (Families Moving Forward) Connect Pro

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05960461

2U01AA026104 (U.S. NIH Grant/Contract)

STUDY00008499

Details and patient eligibility

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. 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 3 patient groups

FMF (Families Moving Forward) Connect Pro with ECHO implementation

Experimental group

Description:

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.

Treatment:

Behavioral: FMF (Families Moving Forward) Connect Pro

Behavioral: ECHO (Extension of Community Healthcare Outcomes) implementation.

FMF (Families Moving Forward) Connect Pro with Self-directed materials

Experimental group

Description:

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.

Treatment:

Behavioral: FMF (Families Moving Forward) Connect Pro

Behavioral: Self-Directed Learning implementation.

Waitlist Comparison Group

No Intervention group

Description:

The waitlist comparison group will receive FMF Connect Pro via Self-directed materials after completing assessments at the 6-month timepoint.