Recruiting

FMF Connect Pro

Sponsor:

University of Rochester

Code:

NCT05960461

Conditions

Fetal Alcohol Spectrum Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

FMF (Families Moving Forward) Connect Pro

ECHO (Extension of Community Healthcare Outcomes) implementation.

Self-Directed Learning implementation.

Study Details

Brief summary:

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.

Conditions

Fetal Alcohol Spectrum Disorders

Study ID

NCT05960461

Start date

Mar 22, 2024

Status verified date

Jun, 2025

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

no intervention: Waitlist Comparison Group

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

Interventions

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

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.

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 measure

  • Reach: proportion of agencies who accept introductory webinar presentation [ Time Frame: 3 months prior to baseline ]
  • Reach: proportion of mental health providers who enroll in the study [ Time Frame: 3 months prior to baseline ]
  • Reach: proportion of mental health providers who complete data collection [ Time Frame: baseline to 6 months ]
  • Effectiveness: Percentage of clients screened for prenatal alcohol exposure [ Time Frame: baseline to 1 year ]
  • Effectiveness: Number of clients diagnosed with a fetal alcohol spectrum disorder [ Time Frame: baseline to 1 year ]
  • Effectiveness: Number of clients enrolled in FMF Connect Pro Dashboard [ Time Frame: baseline to 1 year ]
  • Adoption: Number of ECHO Sessions Completed [ Time Frame: 6 months ]
  • Adoption: Number of Self-Directed Sessions Completed [ Time Frame: 6 months ]
  • Adoption: Change in Provider FASD-Informed Care Knowledge [ Time Frame: baseline to 6 months ]
  • Adoption: Change in FASD-Informed Care Self-Efficacy [ Time Frame: baseline to 6 months ]
  • Implementation: Change in FASD-informed practice [ Time Frame: baseline to 6 months ]
  • Maintenance: Change in FASD-informed practice [ Time Frame: 6 months to 1 year ]
  • Implementation and Maintenance: FMF Connect Pro Dashboard usage [ Time Frame: baseline to 1 year ]

Central Contacts and Locations

Locations

Mt. Hope Family Center

Recruiting

Rochester, New York, United States, 14608

Contacts

Christie Petrenko, PhD

585-275-2991christie_petrenko@urmc.rochester.edu

Principal Investigator:

Christie L Petrenko, Ph.D.

More Information

Sponsor

University of Rochester

Last update posted

Jun 5, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-06-05.