Trial Outcomes & Findings for Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention (NCT NCT04194489)
NCT ID: NCT04194489
Last Updated: 2023-12-11
Results Overview
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.
COMPLETED
NA
171 participants
baseline to 3-month follow-up
2023-12-11
Participant Flow
Participants were asked to complete an eConsent and several screening questionnaires in REDCap. A total of 66 did not proceed to assignment to study arm for the following reasons: 24 did not meet eligibility criteria, 38 had incomplete data so eligibility was not able to be determined, 3 chose to wait for the subsequent RCT, and 1 was overlooked due to study team error.
Participant milestones
| Measure |
FMF Connect Intervention
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.
|
|---|---|
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Overall Study
STARTED
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105
|
|
Overall Study
Completed Some or All Baseline Surveys
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85
|
|
Overall Study
Installed FMF Connect App
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67
|
|
Overall Study
Completed Some or All Follow-up Surveys
|
52
|
|
Overall Study
COMPLETED
|
52
|
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Overall Study
NOT COMPLETED
|
53
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Reasons for withdrawal
| Measure |
FMF Connect Intervention
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.
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|---|---|
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Overall Study
Withdrawal by Subject
|
5
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Overall Study
Lost to Follow-up
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48
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Baseline Characteristics
Data presented includes all of those with baseline data collection for this measure.
Baseline characteristics by cohort
| Measure |
FMF Connect Intervention
n=100 Participants
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.
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|---|---|
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Age, Continuous
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46.48 Years
STANDARD_DEVIATION 8.72 • n=100 Participants
|
|
Sex: Female, Male
Female
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98 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=100 Participants
|
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Region of Enrollment
United States
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100 participants
n=100 Participants
|
|
Relationship to Child
Biological Parent
|
3 participants
n=100 Participants
|
|
Relationship to Child
Adoptive Parent
|
83 participants
n=100 Participants
|
|
Relationship to Child
Foster Parent
|
7 participants
n=100 Participants
|
|
Relationship to Child
Grandparent
|
7 participants
n=100 Participants
|
|
Relationship to Child
Other Relative
|
8 participants
n=100 Participants
|
|
Phone Operating System
Apple iOS
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62 Participants
n=100 Participants
|
|
Phone Operating System
Android
|
38 Participants
n=100 Participants
|
|
Child Age
|
8.09 years
STANDARD_DEVIATION 2.62 • n=100 Participants
|
|
Child Sex at Birth
Male
|
61 Participants
n=100 Participants
|
|
Child Sex at Birth
Female
|
39 Participants
n=100 Participants
|
|
Child Race
African American / Black
|
6 Participants
n=100 Participants
|
|
Child Race
Asian
|
2 Participants
n=100 Participants
|
|
Child Race
White
|
59 Participants
n=100 Participants
|
|
Child Race
Native American / Alaska Native
|
6 Participants
n=100 Participants
|
|
Child Race
Native Hawaiian / Pacific Islander
|
1 Participants
n=100 Participants
|
|
Child Race
More Than One Race
|
23 Participants
n=100 Participants
|
|
Child Race
Unknown
|
3 Participants
n=100 Participants
|
|
Child Ethnicity
Hispanic / Latinx
|
16 Participants
n=100 Participants
|
|
Child Ethnicity
Not Hispanic / Latinx
|
80 Participants
n=100 Participants
|
|
Child Ethnicity
Unknown
|
4 Participants
n=100 Participants
|
|
Eyberg Child Behavior Inventory - Intensity
|
69.75 units on a scale
STANDARD_DEVIATION 8.94 • n=85 Participants • Data presented includes all of those with baseline data collection for this measure.
|
|
Parenting Sense of Competence Scale - Efficacy
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21.17 units on a scale
STANDARD_DEVIATION 5.48 • n=84 Participants • Data presented is only from participants who have complete data for this measure.
|
|
Parenting Sense of Competence Scale - Satisfaction
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34.29 units on a scale
STANDARD_DEVIATION 6.43 • n=85 Participants • Data presented includes only those participants who have complete data for this measure.
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|
Family Needs Met Scale
|
2.35 units on a scale
STANDARD_DEVIATION 0.67 • n=85 Participants • Data is presented for participants with complete data on this measure.
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PRIMARY outcome
Timeframe: baseline to 3-month follow-upPopulation: Data was analyzed from participants with complete data on the measure from both timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention
n=52 Participants
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.
|
|---|---|
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Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up
Baseline
|
69.31 score on a scale
Standard Deviation 9.29
|
|
Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up
Follow-up
|
65.62 score on a scale
Standard Deviation 7.81
|
PRIMARY outcome
Timeframe: baseline to 3-month follow-upPopulation: Data was analyzed from participants with complete data on the measure from both timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention
n=52 Participants
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.
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|---|---|
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Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up
Baseline
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32.90 score on a scale
Standard Deviation 6.18
|
|
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up
Follow-up
|
34.02 score on a scale
Standard Deviation 7.18
|
PRIMARY outcome
Timeframe: baseline to 3-month follow-upPopulation: Data was analyzed from participants with complete data on the measure from both timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention
n=52 Participants
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.
|
|---|---|
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Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up
Baseline
|
22.04 score on a scale
Standard Deviation 6.01
|
|
Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up
Follow-up
|
20.56 score on a scale
Standard Deviation 4.80
|
PRIMARY outcome
Timeframe: baseline to 3-month follow-upPopulation: Data was analyzed from participants with complete data on the measure from both timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention
n=52 Participants
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.
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|---|---|
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Family Needs Questionnaire Baseline to 3-Month Follow-up
Baseline
|
2.34 score on a scale
Standard Deviation 0.71
|
|
Family Needs Questionnaire Baseline to 3-Month Follow-up
Follow-up
|
2.35 score on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: 3-month follow-upPopulation: Data was analyzed from participants with complete data on the measure at the 3-month follow-up timepoint.
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.
Outcome measures
| Measure |
FMF Connect Intervention
n=52 Participants
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.
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|---|---|
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Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up
|
2.92 score on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 3-month follow-upPopulation: Data was analyzed from participants with complete data on the measure at the 3-month follow-up timepoint. Data was missing for 2 participants on this measure.
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. .
Outcome measures
| Measure |
FMF Connect Intervention
n=50 Participants
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.
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|---|---|
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Mean App Quality Score on Mobile App Rating Scale: User Version
|
4.08 score on a scale
Standard Deviation 0.47
|
Adverse Events
FMF Connect Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Christie Petrenko
Mt. Hope Family Center, University of Rochester
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place