The purpose of this study is to test a new smartphone "app" for parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect. The goal of the app is to provide parents/caregivers with useful information to help manage their children's condition and obtain peer support.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
129
The FMF Connect intervention includes cloud infrastructure and an innovative, multilayered mobile app. It incorporates tailored content for parents/caregivers of children (ages 3-12) with FASD or PAE. The app integrates five main components: 1) Dashboard; 2) Learning Modules; 3) Family Forum; 4) Library; and 5) Notebook. Weekly emails are also sent to support motivational engagement.
A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.
University of Rochester Medical Center
Rochester, New York, United States
Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up
The Eyberg Child Behavior Inventory measures the intensity of child behavior problems. Scores are presented as T-scores with a mean of 50 and a standard deviation of 10. A T-score of 60 or higher is considered clinically significant. Higher scores indicate more intense behavior problems.
Time frame: baseline to 12 weeks
Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Sensory Avoid scale measures attributions of behavior based on sensory avoidance. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Time frame: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Sensory Seek scale measures attributions of behavior based on sensory seeking. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Time frame: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Task Willful scale measures attributions of behavior based on willful task avoidance. It ranges from 3 to 18 with higher scores reflecting greater agreement with willful attributions.
Time frame: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Task Ability scale measures attributions of behavior based on ability to complete tasks. It ranges from 5 to 30 with higher scores reflecting greater agreement with neurodevelopmental attributions.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Disruptive Behavior scale measures attributions of behavior based on purposeful disruptive behavior. It ranges from 5 to 30 with higher scores reflecting greater agreement with willful attributions.
Time frame: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Emotional Support scale measures attributions of behavior based on need for emotional support. It ranges from 4 to 24 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Time frame: baseline, 6 weeks, 12 weeks
Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
The Reasons for Children's Behavior measure assesses parents attributions of behavior. It contains 7 total scales. This Dysregulated Behavior scale measures attributions of behavior based on dysregulated behavior. It ranges from 3 to 18 with higher scores reflecting greater agreement with neurodevelopmental attributions.
Time frame: baseline, 6 weeks, 12 weeks
Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The efficacy sub-scale reported here measures how effective parents feel they are and includes 7 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 7 to 42 with higher scores indicating lower feelings of efficacy.
Time frame: baseline, 6 weeks, 12 weeks
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The satisfaction sub-scale reported here includes 9 items, rated on a scale from 1 ("strongly agree") to 6 ("strongly disagree"). Responses are summed, with possible sub-scale score range from 9 to 54 with higher scores indicating higher satisfaction in the parenting role.
Time frame: baseline, 6 weeks, 12 weeks
Family Needs Questionnaire Baseline to 12-Week Follow-up
The family needs questionnaire measures the degree to which family needs are met. The scale includes 18 items reflecting family needs that are rated on a scale from 0 to 4, with 0 being not applicable to 4 being met a great deal. The total score on this measure is created by summing across all items. Total score ranges from 0-72. Higher scores reflect more needs being met.
Time frame: baseline to 12 weeks
FASD Knowledge at Baseline and 12-Week Follow-up
The Knowledge and Advocacy questionnaire assesses caregiver knowledge about FASD and advocacy and ranges from 0 to 28. Higher scores reflect greater knowledge.
Time frame: baseline to 12 weeks
Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up
Participants are asked at follow-up to rate how much their self-care practices have changed over the last 3 months on a 5-point scale ranging from "A lot less self-care (1)" to "A lot more self-care (5)." A score of 3 equates to no change.
Time frame: 12 weeks
Mean App Quality Score on Mobile App Rating Scale: User Version
The mobile app rating scale includes a measure of users perception of app quality. There are 16 items contributing to this score, each rated on a scale from 1 to 5. Total app quality score is presented as a mean with range of 1 to 5, with higher scores reflecting greater perceived quality of the app.
Time frame: 12 weeks