Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder

January 7, 2025 updated by: Christie Petrenko, University of Rochester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Website treatment
This arm will receive access to the FMF teacher adapted website.
Behavioral: Families Moving Forward (FMF) Teacher adapted training
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.
Active Comparator: delayed treatment control
This arm will get the same intervention as the experimental arm delayed by 6 weeks.
Behavioral: Families Moving Forward (FMF) Teacher adapted training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline to 6 weeks
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.
baseline to 6 weeks
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.
baseline to 6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2023

Primary Completion (Actual)

January 29, 2024

Study Completion (Actual)

January 29, 2024

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008481

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fetal Alcohol Spectrum Disorders

Clinical Trials on Families Moving Forward (FMF) Teacher adapted training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe