Provider Training Methods for Fetal Alcohol Spectrum Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Services outside US, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods for training mental health providers to identify and support children with fetal alcohol spectrum disorders (FASD). It compares two training approaches: group tele-mentoring sessions (ECHO implementation) and self-guided online materials (Self-Directed Learning implementation). The study aims to determine which method better equips providers to screen for prenatal alcohol exposure and support families. Licensed mental health providers in the U.S. who work with children aged 3 to 12 and have internet access are ideal candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative training methods that could significantly enhance support for children with FASD.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these training methods are safe for mental health providers?

Research has shown that the ECHO tele-mentoring approach effectively helps healthcare providers better diagnose fetal alcohol spectrum disorders (FASD). Participants find the training both effective and well-received.

The FMF Connect Pro is a mobile app designed for caregivers of children with FASD. Early research suggests users find it easy to use and helpful. No specific safety concerns have been reported, indicating the app is generally safe.

The self-directed learning method involves using the FMF Connect Pro app and similar resources independently. While specific safety data for this method is lacking, the app itself is considered safe for caregivers.

Overall, no known safety issues exist with the training methods being tested. Both ECHO and FMF Connect Pro have demonstrated positive results in improving healthcare providers' knowledge and skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to train mental health providers in managing fetal alcohol spectrum disorders (FASD). Unlike traditional methods that may rely heavily on in-person training sessions, this trial investigates the effectiveness of ECHO tele-mentoring and self-directed learning. ECHO tele-mentoring enables providers to receive real-time guidance and share experiences in a collaborative setting, while self-directed learning offers flexibility by allowing providers to access training materials anytime. These methods aim to improve the screening, diagnosis, and support systems for FASD, potentially leading to better outcomes for affected individuals and their families.

What evidence suggests that this trial's training methods could be effective for FASD?

This trial will compare different training methods for healthcare providers in diagnosing and managing fetal alcohol spectrum disorders (FASD). Research has shown that the ECHO tele-mentoring approach, one of the methods under study, can enhance healthcare providers' ability to diagnose FASD in various regions. This method involves virtual sessions where experts teach providers, improving their skills in identifying and managing FASD. Another method tested in this trial is the FMF Connect Pro app, which studies have found useful and practical for caregivers of children with FASD. This app helps mental health providers learn to check for prenatal alcohol exposure and diagnose FASD. The trial also includes a self-directed learning approach, allowing providers to access similar information online at their own pace, offering more flexibility. Both methods aim to improve providers' knowledge and effectiveness in supporting families dealing with FASD. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for mental health providers in the U.S. who work with children aged 3 to 12 or their families, are fluent in English, and have internet access. It's not for those working outside the U.S. or who don't serve this age group.

Inclusion Criteria

Provides services in the United States

Fluency in English

Licensed mental health provider or supervised trainee

Exclusion Criteria

Provides services outside of the United States

Does not provide mental health services to children ages 3 to 12

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 months

Training

Mental health providers are trained in FMF Connect Pro using either ECHO tele-mentoring or self-directed materials

6 months

13 sessions (bi-weekly for ECHO group)

Follow-up

Participants are monitored for changes in FASD-informed practice and effectiveness of the training

6 months

Online assessments at 6 months and 12 months

Waitlist Implementation

Waitlist group receives FMF Connect Pro via self-directed materials after 6-month assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ECHO implementation
• FMF Connect Pro
• Self-Directed Learning implementation

Trial Overview The study tests 'FMF Connect Pro,' a tool helping providers screen for prenatal alcohol exposure and diagnose FASD. Providers will compare two training methods: a tele-mentoring ECHO approach and self-directed learning, against a waitlist control.

How Is the Trial Designed?

Group I: FMF (Families Moving Forward) Connect Pro with Self-directed materials Experimental Treatment 2 Interventions

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.

Group II: FMF (Families Moving Forward) Connect Pro with ECHO implementation Experimental Treatment 2 Interventions

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.

Group III: Waitlist Comparison Group Active Control 1 Intervention

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

ECHO implementation is already approved in United States for the following indications:

Approved in United States as ECHO implementation for:

• Training for mental health providers in prenatal alcohol exposure screening and FASD diagnosis

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Fetal alcohol spectrum disorder (FASD) is a common but often misdiagnosed condition at birth, leading to inadequate care and support for affected children and their families.

Proper diagnosis of FASD is crucial for providing effective treatment and prevention opportunities, highlighting the need for structured interdisciplinary approaches in education and prevention efforts regarding alcohol consumption during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fetal alcohol spectrum disorders-diagnosis, prognosis, and prevention]. Moder, JE., Ordenewitz, LK., Schlüter, JA., et al.[2021]

A 12-month community intervention involving 19 young women with Fetal Alcohol Spectrum Disorders (FASD) led to significant improvements in their lives, including reduced substance use and increased access to healthcare services.

The intervention's success was attributed to targeted education and collaboration with service providers, along with the support of paraprofessional advocate case managers, highlighting the importance of community-based approaches in addressing FASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot community intervention for young women with fetal alcohol spectrum disorders. Grant, T., Huggins, J., Connor, P., et al.[2019]

The FMF Connect app, designed to support caregivers of children with fetal alcohol spectrum disorders (FASD), was found to be feasible and acceptable, with 84% of caregivers and 94% of providers successfully installing the app during beta testing with 45 participants.

Caregivers engaged positively with the app, averaging 20 minutes of use per session, primarily benefiting from the Learning Modules, which provided valuable information and practical support, while also highlighting areas for technical improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Feasibility of the "Families Moving Forward Connect" Mobile Health Intervention for Caregivers of Children With Fetal Alcohol Spectrum Disorders: Mixed Method Evaluation Within a Systematic User-Centered Design Approach. Petrenko, CLM., Kautz-Turnbull, CC., Roth, AR., et al.[2022]

A consensus symposium with 60 experts highlighted the need for improved integration of care for individuals with Fetal Alcohol Spectrum Disorder (FASD) across various systems, including health, education, and social services.

Key recommendations include increasing training and awareness among providers, implementing multidisciplinary care models, and utilizing accessible electronic medical records to enhance collaboration and improve outcomes for those affected by FASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating care for individuals with FASD: results from a multi-stakeholder symposium. Masotti, P., Longstaffe, S., Gammon, H., et al.[2018]

Parents of children and adults with fetal alcohol spectrum disorders (FASD) often face significant stress and challenges at multiple levels, including individual, family, and systemic, which can impact their ability to provide care.

The study highlights the importance of understanding these family experiences to develop tailored, family-focused interventions that can better support both individuals with FASD and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I'm Doing My Part, I Just Need Help From the Community": Intervention Implications of Foster and Adoptive Parents' Experiences Raising Children and Young Adults With FASD. Petrenko, CLM., Alto, ME., Hart, AR., et al.[2023]

Fetal Alcohol Spectrum Disorder (FASD) is a significant public health issue caused by alcohol exposure during pregnancy, leading to lifelong neurodevelopmental challenges.

The FASD Research Australia Centre of Research Excellence has successfully influenced policies and practices related to the prevention, diagnosis, and management of FASD over the past five years, highlighting the importance of stakeholder engagement in addressing this disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It takes a village: Influencing policy and practice to prevent alcohol use in pregnancy and promote better outcomes for individuals living with Fetal Alcohol Spectrum Disorder. Finlay-Jones, A., Elliott, E., Chapman, A., et al.[2023]

A survey of 800 obstetrician-gynecologists revealed that 66% believe no alcohol consumption is safe during pregnancy, but there is a lack of consensus on the clarity of alcohol's effects on fetal development, with nearly equal opinions on both sides.

Most ob-gyns (57.8%) do not use any validated alcohol risk screening tools, and many feel unprepared to address alcohol-related issues, highlighting a need for improved training and resources in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, opinions, and practice patterns of obstetrician-gynecologists regarding their patients' use of alcohol. Anderson, BL., Dang, EP., Floyd, RL., et al.[2011]

A survey of 52 health and education professionals in Australia and New Zealand revealed that training on fetal alcohol spectrum disorder (FASD) significantly improved their practices, including increased inquiries about alcohol use during pregnancy and enhanced collaboration for assessments.

Participants reported greater knowledge, awareness, and confidence in conducting neurodevelopmental assessments and diagnosing FASD after the training, indicating that such educational initiatives are effective and should be expanded.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and needs of health and education professionals following fetal alcohol spectrum disorder-specific training. Reid, N., White, C., Hawkins, E., et al.[2021]

A significant number of family medicine residency and clerkship directors (46% and 52% response rates, respectively) demonstrated a strong understanding of fetal alcohol spectrum disorders (FASD) and alcohol counseling practices for pregnant women, highlighting the importance of education in preventing these disorders.

Despite high knowledge levels, there is a notable gap in the integration of FASD content in predoctoral programs, with over half of the directors acknowledging the need for its inclusion, suggesting a need for improved medical education policies to address this disparity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal alcohol syndrome: knowledge and attitudes of family medicine clerkship and residency directors. Zoorob, R., Aliyu, MH., Hayes, C.[2013]

This scoping review aims to identify and analyze resources available for health professionals to better understand and manage fetal alcohol spectrum disorder (FASD), addressing a gap in knowledge and expertise among providers.

The review will utilize a comprehensive search of multiple databases and expert consultations to ensure a thorough collection of publicly available resources, which will be critically appraised for quality to enhance the identification and management of FASD in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal alcohol spectrum disorder resources for health professionals: a scoping review protocol. Okurame, JC., Cannon, L., Carter, E., et al.[2022]

The establishment of the first interdisciplinary specialist center for fetal alcohol spectrum disorder (FASD) in Germany has shown that a multidisciplinary approach can effectively address the complex needs of caregivers and professionals, with 81.8% of attendees being female and 42% being foster parents.

The center received positive feedback, with attendees rating the quality of consultation very well, indicating that integrated services can provide significant support and relief for individuals affected by FASD and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a multidisciplinary specialist centre for fetal alcohol spectrum disorders-Lessons learned from a model project in Germany. Weinmann, T., Ordenewitz, LK., Schlüter, JA., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38054571/

Tele-mentoring program to increase healthcare capacity for ... Conclusions: ECHO FASD is a feasible training method that shows promise in increasing diagnostic capacity across many geographic regions.

2. ovid.com ovid.com/journals/acer/pdf/10.1111/acer.15230~extension-for-community-healthcare-outcomes-fetal-alcohol

Extension for Community Healthcare Outcomes fetal alcohol ... Conclusions: ECHO FASD is a feasible training method that shows promise in increas- ing diagnostic capacity across many geographic regions. KEYWORDS.

3. reporter.nih.gov reporter.nih.gov/project-details/11086613

Leveraging Technology to Increase Quality of Life for FASD ... We hypothesize mental health providers trained in Provider-Assisted FMF Connect through ECHO tele-mentoring will evidence greater practice change compared to ...

4. withpower.com withpower.com/trial/phase-fetal-alcohol-spectrum-disorders-9-2023-c67f7

Provider Training Methods for Fetal Alcohol Spectrum ... The first training method involves 13-sessions of tele-mentoring using an Extension of Community Healthcare Outcomes (ECHO) approach. The second training method ...

5. psych.rochester.edu psych.rochester.edu/MHFC/research/current-studies/fetal-alcohol-spectrum-disorders-research-studies/

Fetal Alcohol Spectrum Disorders Research Studies This study aims to develop and test a new intervention called “Thrive” for young adults with fetal alcohol spectrum disorders (FASD).

6. bmcproc.biomedcentral.com bmcproc.biomedcentral.com/articles/10.1186/s12919-023-00272-z

Fetal alcohol spectrum disorders prevention and clinical ... In a third project, her team is creating a tool, based on Extension of Community Healthcare Outcomes (ECHO) approaches, to train providers to ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211609521000038

From surviving to thriving: A new conceptual model ... The “From Surviving to Thriving Model” proposes a paradigm shift, emphasizing personal strengths and quality of life to allow people with FASD to thrive.

8. cifasd.org cifasd.org/research/

Collaborative Initiative on Fetal Alcohol Spectrum Disorders CIFASD is a multidisciplinary, international consortium of research projects and resources charged with improving prevention, diagnosis, and treatment of FASD.