Efficacy Trial of the FMF Connect Mobile Health Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy Trial of the FMF Connect Mobile Health Intervention

Conditions
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Fetal Alcohol Spectrum Disorders

Intervention / Treatment
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* Other: FMF Connect
* Other: Coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study involves a three arm randomized controlled trial with equal allocation to the following conditions: (1) FMF Connect + coaching, (2) FMF Connect alone, and (3) waitlist control. Quantitative survey data will be collected at three timepoints: baseline (T1), 6-weeks (T2), and 12-weeks (T3).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMF Connect Intervention + Coaching<br>Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting. | Other: FMF Connect<br>* 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.<br>Other: Coaching<br>* A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.<br>|
| Experimental: FMF Connect Intervention (no coaching)<br>Participants receive the FMF Connect mobile health app. They do not receive coaching. | Other: FMF Connect<br>* 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.<br>|
| No Intervention: Waitlist comparison group<br>Participants receive the FMF Connect mobile health app at the conclusion of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline to 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. | baseline to 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. | baseline to 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. | baseline to 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. | baseline to 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. | baseline to 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. | baseline to 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. | baseline to 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. | baseline to 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. | 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. | baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 weeks |