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

NCT ID: NCT05960461

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-22

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal Alcohol Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

FMF (Families Moving Forward) Connect Pro

Intervention Type BEHAVIORAL

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

ECHO (Extension of Community Healthcare Outcomes) implementation.

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

FMF (Families Moving Forward) Connect Pro

Intervention Type BEHAVIORAL

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

Self-Directed Learning implementation.

Intervention Type BEHAVIORAL

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.

Waitlist Comparison Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Christie Petrenko

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mt. Hope Family Center

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Christie Petrenko, PhD

Role: primary

585-275-2991 ext. 241

Other Identifiers

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2U01AA026104

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008499

Identifier Type: -

Identifier Source: org_study_id

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