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

January 29, 2024 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
mean knowledge about FASD
Time Frame: 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.
6 weeks
mean behavioral attributions
Time Frame: 6 weeks
Attributions are measured by the Reasons for Children's Behavior (RCB) across seven subscales of behavior and willful or ability-based attributions. Teachers are assessed for whether they agree or disagree with 30 different statements about FASD student behaviors. The survey score ranges from 30-180 with higher scores indicating more adaptive attributions of the students behavior.
6 weeks
mean self-efficacy in teaching.
Time Frame: 6 weeks
The Teacher Self Efficacy Scale (TSES) measures teachers' sense of self-efficacy in teaching and supporting students in the classroom. The tool ranges from 10 to 60 with higher scores indicating more self-efficacy.
6 weeks
mean acceptability of study procedures
Time Frame: 6 weeks
The Study Experiences Survey (SES) was developed for this study and assesses participants' experiences with the study procedures. The survey scores ranges 10-60 with higher scores indicating more acceptability of the study.
6 weeks
mean functionality, usefulness and helpfulness of the website
Time Frame: 6 weeks
The Mobile Application Rating Scale - User Version (uMARS) assesses functionality, usefulness, and helpfulness of technology and information. It is originally used for apps but has been adapted for a website. The scores range from 26-130 with higher scores indicating better functionality, more usefulness and helpfulness.
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)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

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.

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