Efficacy Trial of the FMF Connect Mobile Health Intervention

Fetal Alcohol Spectrum Disorders Clinical Trial

Official title:

Efficacy Trial of the FMF Connect Mobile Health Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028517
• Other study ID #: STUDY00006555
• Secondary ID: U01AA026104
• Status: Completed
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Alcohol Spectrum Disorders

Intervention

Other:
• FMF Connect
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.
• Coaching
A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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, 6 weeks, 12 weeks
Primary	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, 6 weeks, 12 weeks
Primary	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, 6 weeks, 12 weeks
Primary	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, 6 weeks, 12 weeks
Primary	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, 6 weeks, 12 weeks
Primary	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, 6 weeks, 12 weeks
Primary	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, 6 weeks, 12 weeks
Primary	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, 6 weeks, 12 weeks
Primary	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, 6 weeks, 12 weeks
Primary	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
Primary	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	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
Secondary	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