Skip to main content
Clinical Trials/NCT05960461
NCT05960461
Recruiting
N/A

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

University of Rochester1 site in 1 country250 target enrollmentMarch 22, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Fetal Alcohol Spectrum Disorders
Sponsor
University of Rochester
Enrollment
250
Locations
1
Primary Endpoint
Reach: proportion of agencies who accept introductory webinar presentation
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 22, 2024
End Date
April 30, 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christie Petrenko

Professor

University of Rochester

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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

  • Contextual determinants on outcomes: Mean score on the Theoretical Domains Framework (TDF) survey(baseline to 1 year)

Study Sites (1)

Loading locations...

Similar Trials