Fetal Alcohol Spectrum Disorders
Conditions
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.
Interventions
BEHAVIORALFamilies 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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Knowledge About FASD From Baseline to 6 Weeks | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Out of a total of 145 people who completed the consent and screening process, 37 were deemed eligible and 108 were ineligible for the following reasons: 12 did not meet eligibility criteria, 21 were incomplete, and 75 were suspected fraudulent.
Participants by arm
| Arm | Count |
|---|---|
| Website Treatment This arm will receive access to the FMF teacher adapted website.
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. | 21 |
| Delayed Treatment Control This arm will get the same intervention as the experimental arm delayed by 6 weeks.
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. | 16 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Website Treatment | Total | Delayed Treatment Control |
|---|---|---|---|
| Age, Continuous | 43.57 years STANDARD_DEVIATION 13.86 | 41.85 years STANDARD_DEVIATION 11.96 | 39.58 years STANDARD_DEVIATION 8.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 35 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 33 Participants | 15 Participants |
| Sex/Gender, Customized Sex Female | 20 Participants | 36 Participants | 16 Participants |
| Sex/Gender, Customized Sex Male | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Sex Unknown | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 16 |
| other Total, other adverse events | 0 / 21 | 0 / 16 |
| serious Total, serious adverse events | 0 / 21 | 0 / 16 |
Outcome results
Primary
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.
Time frame: baseline to 6 weeks
Population: Participants with data at 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Website Treatment | Change in Mean Knowledge About FASD From Baseline to 6 Weeks | Baseline | 15.50 units on a scale | Standard Deviation 2.53 |
| Website Treatment | Change in Mean Knowledge About FASD From Baseline to 6 Weeks | 6 weeks | 16.57 units on a scale | Standard Deviation 3.54 |
| Delayed Treatment Control | Change in Mean Knowledge About FASD From Baseline to 6 Weeks | Baseline | 17.14 units on a scale | Standard Deviation 2.45 |
| Delayed Treatment Control | Change in Mean Knowledge About FASD From Baseline to 6 Weeks | 6 weeks | 17.14 units on a scale | Standard Deviation 1.94 |
p-value: 0.587RMANOVA
Primary
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.
Time frame: baseline to 6 weeks
Population: participants with complete data on this measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Website Treatment | Change in Personal Efficacy Mean From Baseline to 6 Weeks | baseline | 23.36 units on a scale | Standard Deviation 3.29 |
| Website Treatment | Change in Personal Efficacy Mean From Baseline to 6 Weeks | 6 weeks | 23.54 units on a scale | Standard Deviation 3.24 |
| Delayed Treatment Control | Change in Personal Efficacy Mean From Baseline to 6 Weeks | baseline | 23.25 units on a scale | Standard Deviation 2.53 |
| Delayed Treatment Control | Change in Personal Efficacy Mean From Baseline to 6 Weeks | 6 weeks | 23.08 units on a scale | Standard Deviation 2.15 |
p-value: 0.874RMANOVA
Primary
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.
Time frame: baseline to 6 weeks
Population: participants with complete data for this measure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Website Treatment | Change in Teaching Efficacy Means From Baseline to 6 Weeks | baseline | 22.27 units on a scale | Standard Deviation 3.13 |
| Website Treatment | Change in Teaching Efficacy Means From Baseline to 6 Weeks | 6 weeks | 21.83 units on a scale | Standard Deviation 3.92 |
| Delayed Treatment Control | Change in Teaching Efficacy Means From Baseline to 6 Weeks | baseline | 22.67 units on a scale | Standard Deviation 5.48 |
| Delayed Treatment Control | Change in Teaching Efficacy Means From Baseline to 6 Weeks | 6 weeks | 22.42 units on a scale | Standard Deviation 5.38 |
p-value: 0.946RMANOVA
Primary
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.
Time frame: 6 weeks
Population: participants with complete data on this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Difference in Disruptive Behavior Attributions at 6 Weeks | 12.08 units on a scale | Standard Deviation 5.19 |
| Delayed Treatment Control | Mean Difference in Disruptive Behavior Attributions at 6 Weeks | 10.85 units on a scale | Standard Deviation 6.77 |
p-value: 0.608t-test, 2 sided
Primary
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.
Time frame: 6 weeks
Population: participants with complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Difference in Dysregulated Behavior Attributions at 6 Weeks | 10.31 units on a scale | Standard Deviation 3.45 |
| Delayed Treatment Control | Mean Difference in Dysregulated Behavior Attributions at 6 Weeks | 7.77 units on a scale | Standard Deviation 3.61 |
Primary
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.
Time frame: 6 weeks
Population: participants with complete data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Difference in Emotional Support Attributions at 6 Weeks | 18.71 units on a scale | Standard Deviation 3.75 |
| Delayed Treatment Control | Mean Difference in Emotional Support Attributions at 6 Weeks | 17.92 units on a scale | Standard Deviation 4.86 |
p-value: 0.638t-test, 2 sided
Primary
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.
Time frame: 6 weeks
Population: participants with complete data on this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Difference in Sensory Avoiding Attributions at 6 Weeks | 19.36 units on a scale | Standard Deviation 6.02 |
| Delayed Treatment Control | Mean Difference in Sensory Avoiding Attributions at 6 Weeks | 15.85 units on a scale | Standard Deviation 7.39 |
p-value: 0.187t-test, 2 sided
Primary
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.
Time frame: 6 weeks
Population: participants with complete data on this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Difference in Sensory Seeking Attributions at 6 Weeks | 16.38 units on a scale | Standard Deviation 5.84 |
| Delayed Treatment Control | Mean Difference in Sensory Seeking Attributions at 6 Weeks | 14.00 units on a scale | Standard Deviation 4.81 |
p-value: 0.267t-test, 2 sided
Primary
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.
Time frame: 6 weeks
Population: participants with complete data on this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Difference in Task - Ability Attributions at 6 Weeks | 20.71 units on a scale | Standard Deviation 3.6 |
| Delayed Treatment Control | Mean Difference in Task - Ability Attributions at 6 Weeks | 17.62 units on a scale | Standard Deviation 4.54 |
p-value: 0.06t-test, 2 sided
Primary
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.
Time frame: 6 weeks
Population: participants with complete data on this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Difference in Task - Willful Attributions at 6 Weeks | 7.43 units on a scale | Standard Deviation 2.87 |
| Delayed Treatment Control | Mean Difference in Task - Willful Attributions at 6 Weeks | 7.08 units on a scale | Standard Deviation 2.94 |
p-value: 0.765t-test, 2 sided
Primary
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.
Time frame: 6 weeks
Population: participants with complete data for this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Overall Quality of Website (Website Group Only) | 16.88 units on a scale | Standard Deviation 2 |
Primary
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.
Time frame: 6 weeks
Population: participants with complete data on this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Perceived Impact of Website (Website Group Only) | 4.04 units on a scale | Standard Deviation 0.77 |
Primary
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.
Time frame: 6 weeks
Population: participants with complete data on this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Website Treatment | Mean Subjective Quality of Website (Website Group Only) | 3.70 units on a scale | Standard Deviation 0.72 |