Fetal Alcohol Spectrum DisordersNCT05960461
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
A study testing FMF (Families Moving Forward) Connect Pro, ECHO (Extension of Community Healthcare Outcomes) implementation. and Self-Directed Learning implementation. in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- FMF (Families Moving Forward) Connect Pro, ECHO (Extension of Community Healthcare Outcomes) implementation. and Self-Directed Learning implementation.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Provides services outside of the United States
- Does not provide mental health services to children ages 3 to 12
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mt. Hope Family Center
Rochester, New York, 14608
Christie Petrenko, PhD, 585-275-2991 ext. 241, christie_petrenko@urmc.rochester.edu
Christie L Petrenko, Ph.D.
About this study
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.
Read more
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.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- FMF (Families Moving Forward) Connect Pro, ECHO (Extension of Community Healthcare Outcomes) implementation., Self-Directed Learning implementation.
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMF (Families Moving Forward) Connect ProBehavioural
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
ECHO (Extension of Community Healthcare Outcomes) implementation.Behavioural
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.
Self-Directed Learning implementation.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| FMF (Families Moving Forward) Connect Pro with ECHO implementation | Experimental | 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. Receives: Behavioral: FMF (Families Moving Forward) Connect Pro; Behavioral: ECHO (Extension of Community Healthcare Outcomes) implementation. |
| FMF (Families Moving Forward) Connect Pro with Self-directed materials | Experimental | 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. Receives: Behavioral: FMF (Families Moving Forward) Connect Pro; Behavioral: Self-Directed Learning implementation. |
| Waitlist Comparison Group | No intervention | The waitlist comparison group will receive FMF Connect Pro via Self-directed materials after completing assessments at the 6-month timepoint. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months prior to baseline
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.
Measured: 3 months prior to baseline
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.
Measured: baseline to 6 months
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.
Measured: baseline to 1 year
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).
Measured: baseline to 1 year
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.
Measured: baseline to 1 year
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: baseline to 6 months
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.
Measured: baseline to 6 months
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.
Measured: baseline to 6 months
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.
Measured: 6 months to 1 year
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.
Measured: baseline to 1 year
Secondary outcomes (1)
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.
Measured: baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start22 Mar 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Christie Petrenko, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960461
- Sponsor's protocol ID
- STUDY00008499
- Other IDs
- 2U01AA026104
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be transferred to the National Institute of Alcohol Abuse and Alcoholism (NIAAA) Data Archive (NDA), as required.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families Moving Forward (FMF) Connect Pro for Mental Health Providers
- ClinicalTrials.gov ID
- NCT05960461
- Acronym / sponsor ID
- STUDY00008499
- Conditions
- Fetal Alcohol Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FMF (Families Moving Forward) Connect Pro with ECHO implementation | Experimental | Behavioral: FMF (Families Moving Forward) Connect Pro, Behavioral: ECHO (Extension of Community Healthcare Outcomes) implementation.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. |
| FMF (Families Moving Forward) Connect Pro with Self-directed materials | Experimental | Behavioral: FMF (Families Moving Forward) Connect Pro, Behavioral: Self-Directed Learning implementation.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. |
| Waitlist Comparison Group | No intervention | –The waitlist comparison group will receive FMF Connect Pro via Self-directed materials after completing assessments at the 6-month timepoint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Provides services outside of the United States
- Does not provide mental health services to children ages 3 to 12
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMF (Families Moving Forward) Connect ProFMF 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 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 | Behavioural | FMF (Families Moving Forward) Connect Pro with ECHO implementation, FMF (Families Moving Forward) Connect Pro with Self-directed materials |
| 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. | Behavioural | FMF (Families Moving Forward) Connect Pro with ECHO implementation |
| 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. | Behavioural | FMF (Families Moving Forward) Connect Pro with Self-directed materials |
Primary outcome
Reach: proportion of agencies who accept introductory webinar presentation
Time frame: 3 months prior to baseline
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
Time frame: 3 months prior to baseline
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
Time frame: baseline to 6 months
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
Time frame: baseline to 1 year
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
Time frame: baseline to 1 year
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
Time frame: baseline to 1 year
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
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: baseline to 6 months
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
Time frame: baseline to 6 months
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
Time frame: baseline to 6 months
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
Time frame: 6 months to 1 year
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
Time frame: baseline to 1 year
FMF Connect Pro Dashboard analytics will be extracted to measure the number of times providers accessed the website.
1 secondary outcome
Contextual determinants on outcomes: Mean score on the Theoretical Domains Framework (TDF) survey
Time frame: baseline to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified study data will be transferred to the National Institute of Alcohol Abuse and Alcoholism (NIAAA) Data Archive (NDA), as required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mt. Hope Family Center
Rochester, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMF (Families Moving Forward) Connect Pro, ECHO (Extension of Community Healthcare Outcomes) implementation. and Self-Directed Learning implementation. in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach: proportion of agencies who accept introductory webinar presentation (time frame: 3 months prior to baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.