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NCT Number: NCT05960461

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

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.

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Key information

Conditions

Fetal Alcohol Spectrum Disorders Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Pregnancy Complications Substance-Related Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mt. Hope Family Center

Rochester, New York, 14608, United States

Location status: Recruiting

Location contact

Christie L Petrenko, Ph.D.

PRINCIPAL_INVESTIGATOR

Christie Petrenko, PhD

CONTACT

[email protected]

585-275-2991 ext. 241

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMF (Families Moving Forward) Connect Pro

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:

  • Routine screening of prenatal alcohol exposure (PAE)
  • Apply DSM-5 diagnostic criteria for "Neurodevelopmental Disorder Associated with Prenatal Alcohol Exposure (ND-PAE)"
  • 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.

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.

Self-Directed Learning implementation.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Secondary outcomes

  1. Contextual determinants on outcomes: Mean score on the Theoretical Domains Framework (TDF) survey

    Time frame: baseline to 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2023
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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