Back to resultsStudy of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder
Primary Purpose
Fetal Alcohol Spectrum Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Families Moving Forward (FMF) Teacher adapted training
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders
Eligibility Criteria
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)
Sites / Locations
- University of Rochester Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Website treatment
delayed treatment control
Arm Description
This arm will receive access to the FMF teacher adapted website.
This arm will get the same intervention as the experimental arm delayed by 6 weeks.
Outcomes
Primary Outcome Measures
mean knowledge about FASD
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.
mean behavioral attributions
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.
mean self-efficacy in teaching.
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.
mean acceptability of study procedures
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.
mean functionality, usefulness and helpfulness of the website
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05986565
First Posted
August 3, 2023
Last Updated
August 24, 2023
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT05986565
Brief Title
Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder
Official Title
Pilot Trial of the FMF Connect Teacher Companion Website
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Website treatment
Arm Type
Experimental
Arm Description
This arm will receive access to the FMF teacher adapted website.
Arm Title
delayed treatment control
Arm Type
Active Comparator
Arm Description
This arm will get the same intervention as the experimental arm delayed by 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Families Moving Forward (FMF) Teacher adapted training
Intervention Description
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.
Primary Outcome Measure Information:
Title
mean knowledge about FASD
Description
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.
Time Frame
6 weeks
Title
mean behavioral attributions
Description
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.
Time Frame
6 weeks
Title
mean self-efficacy in teaching.
Description
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.
Time Frame
6 weeks
Title
mean acceptability of study procedures
Description
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.
Time Frame
6 weeks
Title
mean functionality, usefulness and helpfulness of the website
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carson Kautz-Turnbull, MA
Phone
5852752991
Email
carson_kautz@urmc.rochester.edu
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carson Kautz-Turnbull, MA
Email
carson_kautz@urmc.rochester.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Families Moving Forward Website Behavioral Intervention for Teachers of Students With Fetal Alcohol Spectrum Disorder
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