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Recruiting NCT05960461

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

No phase Interventional Fetal Alcohol Spectrum Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FMF (Families Moving Forward) Connect Pro, ECHO (Extension of Community Healthcare Outcomes) implementation., Self-Directed Learning implementation..
Who it may be relevant to
Registry conditions: Fetal Alcohol Spectrum Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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: 1. Routine screening of prenatal alcohol exposure (PAE) 2. Apply DSM-5 diagnostic criteria for "Neurodevelopmental Disorder Associated with Prenatal Alcohol Exposure (ND-PAE)" 3. Support caregivers using the FMF Connect app FMF Connect Pro inv
  • Behavioral 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.
  • Behavioral 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.

Primary outcome measures

  • Reach: proportion of agencies who accept introductory webinar presentation [Time frame: 3 months prior to baseline]
  • Reach: proportion of mental health providers who enroll in the study [Time frame: 3 months prior to baseline]
  • Reach: proportion of mental health providers who complete data collection [Time frame: baseline to 6 months]
  • Effectiveness: Percentage of clients screened for prenatal alcohol exposure [Time frame: baseline to 1 year]
  • Effectiveness: Number of clients diagnosed with a fetal alcohol spectrum disorder [Time frame: baseline to 1 year]
  • Effectiveness: Number of clients enrolled in FMF Connect Pro Dashboard [Time frame: baseline to 1 year]
  • Adoption: Number of ECHO Sessions Completed [Time frame: 6 months]
  • Adoption: Number of Self-Directed Sessions Completed [Time frame: 6 months]
  • Adoption: Change in Provider FASD-Informed Care Knowledge [Time frame: baseline to 6 months]
  • Adoption: Change in FASD-Informed Care Self-Efficacy [Time frame: baseline to 6 months]
Secondary outcome measures (1)
  • Contextual determinants on outcomes: Mean score on the Theoretical Domains Framework (TDF) survey [Time frame: baseline to 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mt. Hope Family Center — Rochester

Identifiers

NCT: NCT05960461 · STUDY00008499 · 2U01AA026104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗