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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment ECHO implementation for Fetal Alcohol Spectrum Disorders?

The Families Moving Forward (FMF) Connect, a mobile health intervention derived from the FMF Program, shows promise in improving accessibility to FASD-informed care for caregivers, suggesting that similar approaches like ECHO implementation could be effective in supporting families dealing with FASD. ^{1 2 3 4 5}

Is the Families Moving Forward Connect Pro intervention safe for humans?

The available research does not provide specific safety data for the Families Moving Forward Connect Pro intervention, but it is a mobile health app designed to support caregivers of children with fetal alcohol spectrum disorders, suggesting it is likely safe for general use. ^{2 3 4 6 7}

How is the treatment for fetal alcohol spectrum disorders using ECHO implementation and FMF Connect Pro different from other treatments?

This treatment is unique because it focuses on training healthcare providers using the ECHO (Extension of Community Healthcare Outcomes) approach and FMF Connect Pro, which are designed to improve the knowledge and skills of professionals in managing fetal alcohol spectrum disorders. Unlike traditional treatments, this method emphasizes education and support for healthcare providers to ensure accurate diagnosis and effective care for affected individuals and their families. ^{2 8 9 10 11}

Eligibility Criteria

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

Fluency in English

Licensed mental health provider or supervised trainee

I provide mental health services to children aged 3-12 or their families.

Exclusion Criteria

Provides services outside of the United States

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A pilot community intervention for young women with fetal alcohol spectrum disorders. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Fetal alcohol spectrum disorder resources for health professionals: a scoping review protocol. [2022]

3. Canada 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Establishing a multidisciplinary specialist centre for fetal alcohol spectrum disorders-Lessons learned from a model project in Germany. [2023]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Integrating care for individuals with FASD: results from a multi-stakeholder symposium. [2018]

7. Wales 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. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Knowledge, opinions, and practice patterns of obstetrician-gynecologists regarding their patients' use of alcohol. [2011]

9. Germany pubmed.ncbi.nlm.nih.gov

[Fetal alcohol spectrum disorders-diagnosis, prognosis, and prevention]. [2021]

10. Australia pubmed.ncbi.nlm.nih.gov

Outcomes and needs of health and education professionals following fetal alcohol spectrum disorder-specific training. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Fetal alcohol syndrome: knowledge and attitudes of family medicine clerkship and residency directors. [2013]