Fetal Alcohol Spectrum DisordersNCT05986565
Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder
A study testing Families Moving Forward (FMF) Teacher adapted training in people with Fetal Alcohol Spectrum Disorders, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to find out if the FMF Connect Teacher Companion website is acceptable and usable by teachers. The FMF Connect Teacher Companion website is a website for teachers adapted from the Families Moving Forward (FMF) Program. 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?
- Families Moving Forward (FMF) Teacher adapted training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2023to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be an educational professional currently actively employed in a school setting in the United States
- Be above the age of 18 years old
- Have direct, consistent contact with a student with a diagnosed fetal alcohol spectrum disorder (FASD) or confirmed prenatal alcohol exposure (PAE) between the ages of 5-12, (i.e. grades K to 5) in a special or general education classroom
- Have reliable access to the Internet
- Be able to consent for themselves
Who cannot join
- They are unable to read English
- They do not have direct, consistent contact with a student with a diagnosed FASD between ages 5-12 (e.g., substitute teacher, principal)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Pilot Trial of the FMF Connect Teacher Companion Website
The purpose of this study is to find out if the FMF Connect Teacher Companion website is acceptable and usable by teachers. The FMF Connect Teacher Companion website is a website for teachers adapted from the Families Moving Forward (FMF) Program. The FMF Program is an evidence-based intervention for caregivers of children with FASD. The study will determine if the a web page intervention is feasible and acceptable by looking at enrollment and retention of study subjects and acceptability of assessments.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Families Moving Forward (FMF) Teacher adapted training
- 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.
Families Moving Forward (FMF) Teacher adapted trainingBehavioural
The FMF Connect Teacher Companion website is designed to offer teachers evidence-based education about FASD and strategies to support students with FASD. It is adapted from the FMF Program and FMF Connect, evidence based interventions to support caregivers of children with FASD. The FMF Program and FMF Connect aim to improve caregivers' efficacy and satisfaction as a parent, efficacy, attributions for their child's behavior, and the parent-child relationship.
| Study group | Role | What they receive |
|---|---|---|
| Website treatment | Experimental | This arm will receive access to the FMF teacher adapted website. Receives: Behavioral: Families Moving Forward (FMF) Teacher adapted training |
| delayed treatment control | Active comparator | This arm will get the same intervention as the experimental arm delayed by 6 weeks. Receives: Behavioral: Families Moving Forward (FMF) Teacher adapted training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Knowledge About FASD From Baseline to 6 Weeks
Teacher FASD knowledge will be measured using the "Fetal Alcohol Spectrum Disorder (FASD) Knowledge" survey. The survey scores range from 0-33 with higher scores indicating more knowledge about FASD.
Measured: baseline to 6 weeks
Change in Personal Efficacy Mean From Baseline to 6 Weeks
Personal efficacy will be measured by the Personal Efficacy subscale of the Teaching Self-Efficacy Scale. This subscale has 5 items and ranges from 5-30, with higher scores indicating higher perceived personal efficacy.
Measured: baseline to 6 weeks
Change in Teaching Efficacy Means From Baseline to 6 Weeks
Teaching efficacy will be measured by the Teaching Efficacy subscale of the Teaching Self-Efficacy Scale. This subscale has 5 items and ranges from 5-30, with higher scores indicating higher perceived teaching efficacy.
Measured: baseline to 6 weeks
Mean Difference in Sensory Seeking Attributions at 6 Weeks
Sensory seeking attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 5 items and scores range from 5-30, with higher scores representing higher endorsement of sensory seeking attributions.
Measured: 6 weeks
Mean Difference in Sensory Avoiding Attributions at 6 Weeks
Sensory avoiding attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 5 items and scores range from 5-30, with higher scores representing higher endorsement of sensory avoiding attributions.
Measured: 6 weeks
Mean Difference in Task - Willful Attributions at 6 Weeks
Task - willful attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 3 items and scores range from 3-18, with higher scores representing higher endorsement of task - willful attributions.
Measured: 6 weeks
Mean Difference in Task - Ability Attributions at 6 Weeks
Task - ability attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 5 items and scores range from 5-30, with higher scores representing higher endorsement of task - ability attributions.
Measured: 6 weeks
Mean Difference in Disruptive Behavior Attributions at 6 Weeks
Disruptive behavior attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 5 items and scores range from 5-30, with higher scores representing higher endorsement of disruptive behavior attributions.
Measured: 6 weeks
Mean Difference in Emotional Support Attributions at 6 Weeks
Emotional support seeking attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 4 items and scores range from 4-24, with higher scores representing higher endorsement of emotional support seeking attributions.
Measured: 6 weeks
Mean Difference in Dysregulated Behavior Attributions at 6 Weeks
Dysregulated behavior attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 3 items and scores range from 3-18, with higher scores representing higher endorsement of dysregulated behavior attributions.
Measured: 6 weeks
Mean Overall Quality of Website (Website Group Only)
Overall quality will be measured using the Mobile Application Rating Scale - user version. Overall quality is a sum of the Engagement, Functionality, Aesthetics, and Information subscales. Each subscale represents a mean of items and ranges from 1 to 6. The overall total quality score is a sum of these scales and ranges from 4 to 24, with higher scores indicating higher overall quality.
Measured: 6 weeks
Mean Subjective Quality of Website (Website Group Only)
Subjective quality will be measured using the Subjective Quality subscale of the Mobile Application Rating Scale - user version. This subscale has 4 items in total. Each item is rated on a scale from 1 to 6 and the total score represents a mean across items, with higher scores indicating higher subjective quality.
Measured: 6 weeks
Mean Perceived Impact of Website (Website Group Only)
Perceived impact will be measured using the Perceived Impact subscale of the Mobile Application Rating Scale - user version. This subscale has 5 items in total. Items are rated on a scale from 1 to 6. Total scores represent a mean rating across items, with higher scores indicating higher perceived impact.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start24 Aug 2023
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christie Petrenko, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986565
- Sponsor's protocol ID
- STUDY00008481
- Status last verified
- Jan 2025
- First submitted
- 3 Aug 2023
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kautz-Turnbull C, Carmichael Olson H, Coles C, Tapparello C, Love K, Luehmann A, Cole L, Toth S, Speybroeck E, Petrenko CLM. The Families Moving Forward Connect Teacher Companion website: Development and initial pilot randomized trial of an FASD-informed resource for teachers. Alcohol Clin Exp Res (Hoboken). 2025 Dec;49(12):2796-2809. doi: 10.1111/acer.70189. Epub 2025 Nov 12.
PubMed 41225288
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of the FMF Connect Teacher Companion Website
- ClinicalTrials.gov ID
- NCT05986565
- Acronym / sponsor ID
- STUDY00008481
- Conditions
- Fetal Alcohol Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if the FMF Connect Teacher Companion website is acceptable and usable by teachers. The FMF Connect Teacher Companion website is a website for teachers adapted from the Families Moving Forward (FMF) Program. The FMF Program is an evidence-based intervention for caregivers of children with FASD. The study will determine if the a web page intervention is feasible and acceptable by looking at enrollment and retention of study subjects and acceptability of assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Website treatment | Experimental | Behavioral: Families Moving Forward (FMF) Teacher adapted trainingThis arm will receive access to the FMF teacher adapted website. |
| delayed treatment control | Active comparator | Behavioral: Families Moving Forward (FMF) Teacher adapted trainingThis arm will get the same intervention as the experimental arm delayed by 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be an educational professional currently actively employed in a school setting in the United States
- Be above the age of 18 years old
- Have direct, consistent contact with a student with a diagnosed fetal alcohol spectrum disorder (FASD) or confirmed prenatal alcohol exposure (PAE) between the ages of 5-12, (i.e. grades K to 5) in a special or general education classroom
- Have reliable access to the Internet
- Be able to consent for themselves
Key exclusion criteria (2 listed)
- They are unable to read English
- They do not have direct, consistent contact with a student with a diagnosed FASD between ages 5-12 (e.g., substitute teacher, principal)
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 |
|---|---|---|
| Families Moving Forward (FMF) Teacher adapted trainingThe FMF Connect Teacher Companion website is designed to offer teachers evidence-based education about FASD and strategies to support students with FASD. It is adapted from the FMF Program and FMF Connect, evidence based interventions to support caregivers of children with FASD. The FMF Program and FMF Connect aim to improve caregivers' efficacy and satisfaction as a parent, efficacy, attributions for their child's behavior, and the parent-child relationship. | Behavioural | Website treatment, delayed treatment control |
Primary outcome
Change in Mean Knowledge About FASD From Baseline to 6 Weeks
Time frame: baseline to 6 weeks
Teacher FASD knowledge will be measured using the "Fetal Alcohol Spectrum Disorder (FASD) Knowledge" survey. The survey scores range from 0-33 with higher scores indicating more knowledge about FASD.
Change in Personal Efficacy Mean From Baseline to 6 Weeks
Time frame: baseline to 6 weeks
Personal efficacy will be measured by the Personal Efficacy subscale of the Teaching Self-Efficacy Scale. This subscale has 5 items and ranges from 5-30, with higher scores indicating higher perceived personal efficacy.
Change in Teaching Efficacy Means From Baseline to 6 Weeks
Time frame: baseline to 6 weeks
Teaching efficacy will be measured by the Teaching Efficacy subscale of the Teaching Self-Efficacy Scale. This subscale has 5 items and ranges from 5-30, with higher scores indicating higher perceived teaching efficacy.
Mean Difference in Sensory Seeking Attributions at 6 Weeks
Time frame: 6 weeks
Sensory seeking attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 5 items and scores range from 5-30, with higher scores representing higher endorsement of sensory seeking attributions.
Mean Difference in Sensory Avoiding Attributions at 6 Weeks
Time frame: 6 weeks
Sensory avoiding attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 5 items and scores range from 5-30, with higher scores representing higher endorsement of sensory avoiding attributions.
Mean Difference in Task - Willful Attributions at 6 Weeks
Time frame: 6 weeks
Task - willful attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 3 items and scores range from 3-18, with higher scores representing higher endorsement of task - willful attributions.
Mean Difference in Task - Ability Attributions at 6 Weeks
Time frame: 6 weeks
Task - ability attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 5 items and scores range from 5-30, with higher scores representing higher endorsement of task - ability attributions.
Mean Difference in Disruptive Behavior Attributions at 6 Weeks
Time frame: 6 weeks
Disruptive behavior attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 5 items and scores range from 5-30, with higher scores representing higher endorsement of disruptive behavior attributions.
Mean Difference in Emotional Support Attributions at 6 Weeks
Time frame: 6 weeks
Emotional support seeking attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 4 items and scores range from 4-24, with higher scores representing higher endorsement of emotional support seeking attributions.
Mean Difference in Dysregulated Behavior Attributions at 6 Weeks
Time frame: 6 weeks
Dysregulated behavior attributions will be measured using the "Reasons for Children's Behavior" survey. This subscale has 3 items and scores range from 3-18, with higher scores representing higher endorsement of dysregulated behavior attributions.
Mean Overall Quality of Website (Website Group Only)
Time frame: 6 weeks
Overall quality will be measured using the Mobile Application Rating Scale - user version. Overall quality is a sum of the Engagement, Functionality, Aesthetics, and Information subscales. Each subscale represents a mean of items and ranges from 1 to 6. The overall total quality score is a sum of these scales and ranges from 4 to 24, with higher scores indicating higher overall quality.
Mean Subjective Quality of Website (Website Group Only)
Time frame: 6 weeks
Subjective quality will be measured using the Subjective Quality subscale of the Mobile Application Rating Scale - user version. This subscale has 4 items in total. Each item is rated on a scale from 1 to 6 and the total score represents a mean across items, with higher scores indicating higher subjective quality.
Mean Perceived Impact of Website (Website Group Only)
Time frame: 6 weeks
Perceived impact will be measured using the Perceived Impact subscale of the Mobile Application Rating Scale - user version. This subscale has 5 items in total. Items are rated on a scale from 1 to 6. Total scores represent a mean rating across items, with higher scores indicating higher perceived impact.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41225288Kautz-Turnbull C, Carmichael Olson H, Coles C, Tapparello C, Love K, Luehmann A, Cole L, Toth S, Speybroeck E, Petrenko CLM. The Families Moving Forward Connect Teacher Companion website: Development and initial pilot randomized trial of an FASD-informed resource for teachers. Alcohol Clin Exp Res (Hoboken). 2025 Dec;49(12):2796-2809. doi: 10.1111/acer.70189. Epub 2025 Nov 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families Moving Forward (FMF) Teacher adapted training 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 5 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: finished, as of the sponsor's last update on 29 Jan 2025. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Knowledge About FASD From Baseline to 6 Weeks (time frame: baseline to 6 weeks). 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?
On the ClinicalTrials.gov record for NCT05986565, which also lists 1 linked publication.
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 29 Jan 2025.