Clinical trial NCT05960461: Families Moving Forward (FMF) Connect Pro for Mental Health Providers
Official title: Families Moving Forward (FMF) Connect Pro for Mental Health Providers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-07-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reach: proportion of agencies who accept introductory webinar presentation
timeFrame: 3 months prior to baseline
measure: Reach: proportion of mental health providers who enroll in the study
timeFrame: 3 months prior to baseline
measure: Reach: proportion of mental health providers who complete data collection
timeFrame: baseline to 6 months
measure: Effectiveness: Percentage of clients screened for prenatal alcohol exposure
timeFrame: baseline to 1 year
measure: Effectiveness: Number of clients diagnosed with a fetal alcohol spectrum disorder
timeFrame: baseline to 1 year
measure: Effectiveness: Number of clients enrolled in FMF Connect Pro Dashboard
timeFrame: baseline to 1 year
measure: Adoption: Number of ECHO Sessions Completed
timeFrame: 6 months
measure: Adoption: Number of Self-Directed Sessions Completed
timeFrame: 6 months
measure: Adoption: Change in Provider FASD-Informed Care Knowledge
timeFrame: baseline to 6 months
measure: Adoption: Change in FASD-Informed Care Self-Efficacy
timeFrame: baseline to 6 months
measure: Implementation: Change in FASD-informed practice
timeFrame: baseline to 6 months
measure: Maintenance: Change in FASD-informed practice
timeFrame: 6 months to 1 year
measure: Implementation and Maintenance: FMF Connect Pro Dashboard usage
timeFrame: baseline to 1 year
Secondary outcomes:
measure: Contextual determinants on outcomes: Mean score on the Theoretical Domains Framework (TDF) survey
timeFrame: baseline to 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mt. Hope Family Center
state: New York
Study officials:
References: