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

Primary Purpose

Fetal Alcohol Spectrum Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FMF (Families Moving Forward) Connect Pro
ECHO (Extension of Community Healthcare Outcomes) implementation.
Self-Directed Learning implementation.
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mt. Hope Family Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

FMF (Families Moving Forward) Connect Pro with ECHO implementation

FMF (Families Moving Forward) Connect Pro with Self-directed materials

Waitlist Comparison Group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 16, 2023
Last Updated
July 27, 2023
Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05960461
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMF (Families Moving Forward) Connect Pro with ECHO implementation
Arm Type
Experimental
Arm Description
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.
Arm Title
FMF (Families Moving Forward) Connect Pro with Self-directed materials
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Comparison Group
Arm Type
No Intervention
Arm Description
The waitlist comparison group will receive FMF Connect Pro via Self-directed materials after completing assessments at the 6-month timepoint.
Intervention Type
Behavioral
Intervention Name(s)
FMF (Families Moving Forward) Connect Pro
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
ECHO (Extension of Community Healthcare Outcomes) implementation.
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Directed Learning implementation.
Intervention Description
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 Information:
Title
Reach: proportion of agencies who accept introductory webinar presentation
Description
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.
Time Frame
3 months prior to baseline
Title
Reach: proportion of mental health providers who enroll in the study
Description
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.
Time Frame
3 months prior to baseline
Title
Reach: proportion of mental health providers who complete data collection
Description
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.
Time Frame
baseline to 6 months
Title
Effectiveness: Percentage of clients screened for prenatal alcohol exposure
Description
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.
Time Frame
baseline to 1 year
Title
Effectiveness: Number of clients diagnosed with a fetal alcohol spectrum disorder
Description
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).
Time Frame
baseline to 1 year
Title
Effectiveness: Number of clients enrolled in FMF Connect Pro Dashboard
Description
FMF Connect Pro Dashboard analytics will be examined to assess the number of clients providers have enrolled in FMF Connect.
Time Frame
baseline to 1 year
Title
Adoption: Number of ECHO Sessions Completed
Description
Participant attendance at each ECHO session will be measured for FMF Connect Pro with ECHO implementation group. There are 13 total sessions.
Time Frame
6 months
Title
Adoption: Number of Self-Directed Sessions Completed
Description
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.
Time Frame
6 months
Title
Adoption: Change in Provider FASD-Informed Care Knowledge
Description
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.
Time Frame
baseline to 6 months
Title
Adoption: Change in FASD-Informed Care Self-Efficacy
Description
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.
Time Frame
baseline to 6 months
Title
Implementation: Change in FASD-informed practice
Description
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.
Time Frame
baseline to 6 months
Title
Maintenance: Change in FASD-informed practice
Description
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.
Time Frame
6 months to 1 year
Title
Implementation and Maintenance: FMF Connect Pro Dashboard usage
Description
FMF Connect Pro Dashboard analytics will be extracted to measure the number of times providers accessed the website.
Time Frame
baseline to 1 year
Secondary Outcome Measure Information:
Title
Contextual determinants on outcomes: Mean score on the Theoretical Domains Framework (TDF) survey
Description
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.
Time Frame
baseline to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Mt. Hope Family Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified study data will be transferred to the National Institute of Alcohol Abuse and Alcoholism (NIAAA) Data Archive (NDA), as required.
IPD Sharing Time Frame
Data will be transferred twice a year as required by NIAAA-DA. Per current NIAAA NDA policy (on website), the research community will have access to data two years after the award ends. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
IPD Sharing Access Criteria
Data will be findable for the research community through the NDA Collection for this project when funded. For all publications, an NDA study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication.
IPD Sharing URL
https://nda.nih.gov/niaaa/

Learn more about this trial

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

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