Efficacy Trial of the FMF Connect Mobile Health Intervention
- Conditions
- Fetal Alcohol Spectrum Disorders
- Registration Number
- NCT05028517
- Lead Sponsor
- University of Rochester
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Biological parent or other primary caregiver (e.g., foster or adoptive parent, relative, legal guardian) of a child with FASD or prenatal alcohol exposure (PAE)
- The parent/caregiver must be at least 18 years old
- The child must between the ages of 3 and 12 years old
- The child has a diagnosis of FASD or has confirmed PAE
- The child has lived with the parent/caregiver for at least 4 months and is expected to remain in the home for at least 1 year
- The parent/caregiver lives in the United States
- The parent/caregiver has a smartphone or ipad with iOS operating system
- The parent/caregiver is not fluent in English (the FMF Connect app and pre-post measures are currently only available in English)
- There is another parent/caregiver of the same child or living in the home that is already enrolled in the study (couples are excluded to prevent dependence in the data)
- The family has previously received or is currently receiving the therapist-led Families Moving Forward (FMF) Program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks baseline, 6 weeks, 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.
Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks baseline, 6 weeks, 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.
Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up baseline to 12 weeks 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.
Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks baseline, 6 weeks, 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.
Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks baseline, 6 weeks, 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.
Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks baseline, 6 weeks, 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.
Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks baseline, 6 weeks, 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.
Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks baseline, 6 weeks, 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.
FASD Knowledge at Baseline and 12-Week Follow-up baseline to 12 weeks The Knowledge and Advocacy questionnaire assesses caregiver knowledge about FASD and advocacy and ranges from 0 to 28. Higher scores reflect greater knowledge.
Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up baseline, 6 weeks, 12 weeks 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.
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up baseline, 6 weeks, 12 weeks 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.
Family Needs Questionnaire Baseline to 12-Week Follow-up baseline to 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up 12 weeks 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.
Mean App Quality Score on Mobile App Rating Scale: User Version 12 weeks 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.
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Rochester Medical Center🇺🇸Rochester, New York, United States