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Behavioural Intervention
Provider Training Methods for Fetal Alcohol Spectrum Disorders
N/A
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 year
Awards & highlights
Study Summary
This trial will compare two methods of training mental health providers in the US to screen for FASD & use a caregiver app to better support families.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, traditional side effects are not applicable. However, participants may experience varying levels of comfort with technology or changes in workload.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adoption: Change in FASD-Informed Care Self-Efficacy
Adoption: Change in Provider FASD-Informed Care Knowledge
Adoption: Number of ECHO Sessions Completed
+10 moreSecondary outcome measures
Contextual determinants on outcomes: Mean score on the Theoretical Domains Framework (TDF) survey
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: FMF (Families Moving Forward) Connect Pro with Self-directed materialsExperimental Treatment2 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 implementationExperimental Treatment2 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 GroupActive Control1 Intervention
The waitlist comparison group will receive FMF Connect Pro via Self-directed materials after completing assessments at the 6-month timepoint.
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Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,000 Total Patients Enrolled
5 Trials studying Fetal Alcohol Spectrum Disorders
498 Patients Enrolled for Fetal Alcohol Spectrum Disorders
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
802 Previous Clinical Trials
1,365,195 Total Patients Enrolled
14 Trials studying Fetal Alcohol Spectrum Disorders
3,411 Patients Enrolled for Fetal Alcohol Spectrum Disorders
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I provide mental health services to children aged 3-12 or their families.
Research Study Groups:
This trial has the following groups:- Group 1: FMF (Families Moving Forward) Connect Pro with ECHO implementation
- Group 2: Waitlist Comparison Group
- Group 3: FMF (Families Moving Forward) Connect Pro with Self-directed materials
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being currently recruited to take part in this experiment?
"Based on clinicaltrials.gov, this research endeavour is not accepting any participants at the moment. It was first created on October 31st 2023 and edited most recently on July 16th 2023. However, there are 12 other studies that remain open to recruitment currently."
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