Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
Primary Purpose
Fetal Alcohol Spectrum Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FMF Connect
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders
Eligibility Criteria
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 with iOS or Android 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
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FMF Connect Intervention
Arm Description
Outcomes
Primary Outcome Measures
Eyberg Child Behavior Inventory at Baseline and 3-Month 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month 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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Family Needs Questionnaire Baseline to 3-Month Follow-up
The family needs questionnaire measures the degree to which family needs are met. The scale includes 20 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 averaging across all items. Total score ranges from 0-4. Higher scores reflect more needs being met. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Secondary Outcome Measures
Participant Perception of Self-care Change Over Intervention Period Reported at 3-month 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.
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. .
Full Information
NCT ID
NCT04194489
First Posted
December 9, 2019
Last Updated
October 9, 2022
Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04194489
Brief Title
Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
Official Title
Feasibility Trial of the FMF Connect Mobile Health Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMF Connect Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
FMF Connect
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up
Description
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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Time Frame
baseline to 3-month follow-up
Title
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up
Description
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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Time Frame
baseline to 3-month follow-up
Title
Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up
Description
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. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Time Frame
baseline to 3-month follow-up
Title
Family Needs Questionnaire Baseline to 3-Month Follow-up
Description
The family needs questionnaire measures the degree to which family needs are met. The scale includes 20 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 averaging across all items. Total score ranges from 0-4. Higher scores reflect more needs being met. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Time Frame
baseline to 3-month follow-up
Secondary Outcome Measure Information:
Title
Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up
Description
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
3-month follow-up
Title
Mean App Quality Score on Mobile App Rating Scale: User Version
Description
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
3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 with iOS or Android 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
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is deposited quarterly into the Collaborative Initiative on Fetal Alcohol Spectrum Disorders central repository.
IPD Sharing Time Frame
It will be available once the data is collected and will be available indefinitely.
IPD Sharing URL
http://www.cifasd.org/data-sharing
Learn more about this trial
Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
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