NCT05986565

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

August 24, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 29, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

August 3, 2023

Results QC Date

November 18, 2024

Last Update Submit

January 7, 2025

Conditions

Fetal Alcohol Spectrum Disorders

Outcome Measures

Primary Outcomes (13)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    6 weeks

Study Arms (2)

Website treatment

EXPERIMENTAL

This arm will receive access to the FMF teacher adapted website.

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.

Behavioral: Families Moving Forward (FMF) Teacher adapted training

Interventions

Families Moving Forward (FMF) Teacher adapted trainingBEHAVIORAL

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.

Website treatmentdelayed treatment control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • 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.

    PMID: 41225288DERIVED

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Pyrin

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Cytoskeletal ProteinsProteinsAmino Acids, Peptides, and ProteinsTripartite Motif Proteins

Results Point of Contact

Title
Christie L. M. Petrenko, Ph.D.
Organization
Mt. Hope Family Center, University of Rochester
christie_petrenko@urmc.rochester.edu
5852752991

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

August 24, 2023

Primary Completion

January 29, 2024

Study Completion

January 29, 2024

Last Updated

January 29, 2025

Results First Posted

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)