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

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960461
• Other study ID #: STUDY00008499
• Secondary ID: 2U01AA026104
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

Intervention

Behavioral:
• 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: 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.
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.

Locations

Country	Name	City	State
United States	Mt. Hope Family Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months prior to baseline
Primary	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.	3 months prior to baseline
Primary	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.	baseline to 6 months
Primary	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.	baseline to 1 year
Primary	Effectiveness: Number of clients diagnosed with a fetal alcohol spectrum disorder	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).	baseline to 1 year
Primary	Effectiveness: Number of clients enrolled in FMF Connect Pro Dashboard	FMF Connect Pro Dashboard analytics will be examined to assess the number of clients providers have enrolled in FMF Connect.	baseline to 1 year
Primary	Adoption: Number of ECHO Sessions Completed	Participant attendance at each ECHO session will be measured for FMF Connect Pro with ECHO implementation group. There are 13 total sessions.	6 months
Primary	Adoption: Number of Self-Directed Sessions Completed	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.	6 months
Primary	Adoption: Change in Provider FASD-Informed Care Knowledge	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.	baseline to 6 months
Primary	Adoption: Change in FASD-Informed Care Self-Efficacy	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.	baseline to 6 months
Primary	Implementation: Change in FASD-informed practice	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.	baseline to 6 months
Primary	Maintenance: Change in FASD-informed practice	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.	6 months to 1 year
Primary	Implementation and Maintenance: FMF Connect Pro Dashboard usage	FMF Connect Pro Dashboard analytics will be extracted to measure the number of times providers accessed the website.	baseline to 1 year
Secondary	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.	baseline to 1 year