Trial Outcomes & Findings for Efficacy Trial of the FMF Connect Mobile Health Intervention (NCT NCT05028517)
NCT ID: NCT05028517
Last Updated: 2026-01-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
baseline, 6 weeks, 12 weeks
Results posted on
2026-01-14
Participant Flow
Participants were asked to complete an eConsent and several screening questionnaires in REDCap. A total of 401 started the eConsent process. 272 were excluded for the following reasons: 37 did not meet inclusion criteria, 228 were incomplete, and 7 were duplicates.
Participant milestones
| Measure |
FMF Connect Intervention + Coaching
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
43
|
|
Overall Study
Completed baseline surveys
|
41
|
39
|
39
|
|
Overall Study
Completed 6-week follow-up surveys
|
30
|
28
|
32
|
|
Overall Study
COMPLETED
|
30
|
23
|
30
|
|
Overall Study
NOT COMPLETED
|
13
|
20
|
13
|
Reasons for withdrawal
| Measure |
FMF Connect Intervention + Coaching
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
20
|
12
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in data available for FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
Baseline characteristics by cohort
| Measure |
FMF Connect Intervention + Coaching
n=43 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=43 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=43 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 7.0 • n=43 Participants
|
43.1 years
STANDARD_DEVIATION 7.6 • n=43 Participants
|
43.7 years
STANDARD_DEVIATION 7.6 • n=43 Participants
|
44.00 years
STANDARD_DEVIATION 7.38 • n=129 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=43 Participants
|
41 Participants
n=43 Participants
|
40 Participants
n=43 Participants
|
124 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=43 Participants
|
2 Participants
n=43 Participants
|
3 Participants
n=43 Participants
|
5 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
3 Participants
n=43 Participants
|
4 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=43 Participants
|
43 Participants
n=43 Participants
|
40 Participants
n=43 Participants
|
124 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
00 Participants
n=43 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
2 Participants
n=43 Participants
|
4 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=43 Participants
|
41 Participants
n=43 Participants
|
39 Participants
n=43 Participants
|
120 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=43 Participants
|
2 Participants
n=43 Participants
|
1 Participants
n=43 Participants
|
3 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=43 Participants
|
0 Participants
n=43 Participants
|
1 Participants
n=43 Participants
|
2 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=43 Participants
|
43 participants
n=43 Participants
|
43 participants
n=43 Participants
|
129 participants
n=129 Participants
|
|
Eyberg Child Behavior Inventory - Intensity Scale
|
69.20 T-score
STANDARD_DEVIATION 8.86 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in data available for FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
69.51 T-score
STANDARD_DEVIATION 7.14 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in data available for FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
68.28 T-score
STANDARD_DEVIATION 9.01 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in data available for FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
69.00 T-score
STANDARD_DEVIATION 8.33 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in data available for FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Reasons for Children's Behavior Scale - Sensory Avoid
|
16.20 units on a scale
STANDARD_DEVIATION 5.32 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in data available for FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
19.18 units on a scale
STANDARD_DEVIATION 5.99 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in data available for FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
15.64 units on a scale
STANDARD_DEVIATION 6.06 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in data available for FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
16.99 units on a scale
STANDARD_DEVIATION 5.95 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in data available for FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Reasons for Children's Behavior Scale - Sensory Seek
|
23.15 units on a scale
STANDARD_DEVIATION 6.43 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
23.90 units on a scale
STANDARD_DEVIATION 4.98 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
22.56 units on a scale
STANDARD_DEVIATION 6.69 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
23.20 units on a scale
STANDARD_DEVIATION 6.06 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Reasons for Children's Behavior Scale - Task Willful
|
10.51 units on a scale
STANDARD_DEVIATION 3.15 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
10.51 units on a scale
STANDARD_DEVIATION 2.89 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
10.05 units on a scale
STANDARD_DEVIATION 3.33 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
10.36 units on a scale
STANDARD_DEVIATION 3.11 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Reasons for Children's Behavior Scale - Task Ability
|
22.95 units on a scale
STANDARD_DEVIATION 4.61 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
23.67 units on a scale
STANDARD_DEVIATION 4.53 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
22.13 units on a scale
STANDARD_DEVIATION 4.26 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
23.57 units on a scale
STANDARD_DEVIATION 4.46 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Reasons for Children's Behavior Scale - Disruptive Behavior
|
16.10 units on a scale
STANDARD_DEVIATION 6.24 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
15.36 units on a scale
STANDARD_DEVIATION 6.32 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
15.26 units on a scale
STANDARD_DEVIATION 7.37 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
15.56 units on a scale
STANDARD_DEVIATION 6.61 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Reasons for Children's Behavior Scale - Emotional Support
|
19.68 units on a scale
STANDARD_DEVIATION 3.86 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
20.82 units on a scale
STANDARD_DEVIATION 3.04 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
20.90 units on a scale
STANDARD_DEVIATION 3.55 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
20.45 units on a scale
STANDARD_DEVIATION 3.52 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Reasons for Children's Behavior Scale - Dysregulated
|
8.83 units on a scale
STANDARD_DEVIATION 3.87 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
9.56 units on a scale
STANDARD_DEVIATION 3.43 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
8.79 units on a scale
STANDARD_DEVIATION 3.57 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
9.06 units on a scale
STANDARD_DEVIATION 3.62 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Parenting Sense of Competence Scale - Efficacy
|
26.78 units on a scale
STANDARD_DEVIATION 5.56 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
26.77 units on a scale
STANDARD_DEVIATION 5.18 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
25.23 units on a scale
STANDARD_DEVIATION 6.58 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
26.27 units on a scale
STANDARD_DEVIATION 5.79 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Parenting Sense of Competence Scale - Satisfaction
|
34.12 units on a scale
STANDARD_DEVIATION 6.93 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
34.05 units on a scale
STANDARD_DEVIATION 7.85 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
33.41 units on a scale
STANDARD_DEVIATION 6.98 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
33.87 units on a scale
STANDARD_DEVIATION 7.20 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Family Needs Met Scale
|
39.93 units on a scale
STANDARD_DEVIATION 10.28 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
38.64 units on a scale
STANDARD_DEVIATION 10.77 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
38.44 units on a scale
STANDARD_DEVIATION 9.62 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
39.02 units on a scale
STANDARD_DEVIATION 10.17 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
|
Knowledge and Advocacy Scale
|
20.56 units on a scale
STANDARD_DEVIATION 2.59 • n=41 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
20.97 units on a scale
STANDARD_DEVIATION 3.38 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
20.77 units on a scale
STANDARD_DEVIATION 3.65 • n=39 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
20.76 units on a scale
STANDARD_DEVIATION 3.20 • n=119 Participants • A total of 129 participants were allocated to the 3 arms. A total of 10 did not complete baseline surveys, resulting in FMF Connect + Coaching = 41, FMF Connect (no coaching) = 39, and Waitlist = 39.
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPopulation: 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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=30 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=23 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=30 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up
Baseline
|
68.33 T-score
Standard Error 1.65
|
69.13 T-score
Standard Error 1.88
|
68.40 T-score
Standard Error 1.65
|
|
Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up
12-week Follow-up
|
64.47 T-score
Standard Error 1.67
|
65.87 T-score
Standard Error 1.90
|
66.03 T-score
Standard Error 1.67
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=28 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=21 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=28 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks
Baseline
|
15.54 score on a scale
Standard Error 1.02
|
18.91 score on a scale
Standard Error 1.17
|
16.57 score on a scale
Standard Error 1.01
|
|
Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks
6-Week Follow-up
|
15.87 score on a scale
Standard Error 1.25
|
19.29 score on a scale
Standard Error 1.45
|
18.25 score on a scale
Standard Error 1.25
|
|
Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks
12-Week Follow-up
|
15.43 score on a scale
Standard Error 1.29
|
17.29 score on a scale
Standard Error 1.49
|
17.57 score on a scale
Standard Error 1.29
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=28 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=21 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=28 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks
Baseline
|
23.79 score on a scale
Standard Error 1.06
|
23.24 score on a scale
Standard Error 1.23
|
23.29 score on a scale
Standard Error 1.06
|
|
Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks
6-Week Follow-up
|
23.36 score on a scale
Standard Error 1.02
|
25.43 score on a scale
Standard Error 1.17
|
24.39 score on a scale
Standard Error 1.02
|
|
Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks
12-Week Follow-up
|
22.61 score on a scale
Standard Error 1.19
|
24.76 score on a scale
Standard Error 1.37
|
23.14 score on a scale
Standard Error 1.19
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=28 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=21 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=28 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks
Baseline
|
10.14 score on a scale
Standard Error 0.576
|
10.67 score on a scale
Standard Error 0.665
|
10.43 score on a scale
Standard Error 0.576
|
|
Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks
6-Week Follow-up
|
9.18 score on a scale
Standard Error 0.527
|
9.86 score on a scale
Standard Error 0.608
|
10.89 score on a scale
Standard Error 0.527
|
|
Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks
12-Week Follow-up
|
8.93 score on a scale
Standard Error 0.576
|
8.57 score on a scale
Standard Error 0.665
|
10.46 score on a scale
Standard Error 0.576
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=28 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=21 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=28 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks
Baseline
|
23.29 score on a scale
Standard Error 0.847
|
22.48 score on a scale
Standard Error 0.978
|
24.32 score on a scale
Standard Error 0.847
|
|
Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks
6-Week Follow-up
|
22.75 score on a scale
Standard Error 0.746
|
22.77 score on a scale
Standard Error 0.862
|
24.57 score on a scale
Standard Error 0.746
|
|
Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks
12-Week Follow-up
|
23.00 score on a scale
Standard Error 0.922
|
21.57 score on a scale
Standard Error 1.07
|
23.68 score on a scale
Standard Error 0.922
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=28 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=21 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=28 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
Baseline
|
14.96 score on a scale
Standard Error 1.28
|
17.05 score on a scale
Standard Error 1.47
|
15.29 score on a scale
Standard Error 1.28
|
|
Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
6-Week Follow-up
|
12.36 score on a scale
Standard Error 1.17
|
13.81 score on a scale
Standard Error 1.35
|
15.50 score on a scale
Standard Error 1.17
|
|
Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
12 Week Follow-up
|
12.07 score on a scale
Standard Error 1.25
|
13.24 score on a scale
Standard Error 1.45
|
14.75 score on a scale
Standard Error 1.25
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=28 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=21 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=28 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks
Baseline
|
19.50 score on a scale
Standard Error 0.744
|
20.29 score on a scale
Standard Error 0.859
|
20.79 score on a scale
Standard Error 0.744
|
|
Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks
6-Week Follow-up
|
20.00 score on a scale
Standard Error 0.603
|
21.43 score on a scale
Standard Error 0.697
|
21.43 score on a scale
Standard Error 0.603
|
|
Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks
12-Week Follow-up
|
19.89 score on a scale
Standard Error 0.636
|
20.91 score on a scale
Standard Error 0.735
|
21.32 score on a scale
Standard Error 0.636
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=28 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=21 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=28 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
Baseline
|
8.36 score on a scale
Standard Error .709
|
9.48 score on a scale
Standard Error .819
|
8.964 score on a scale
Standard Error .709
|
|
Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
6-Week Follow-up
|
9.43 score on a scale
Standard Error .681
|
10.76 score on a scale
Standard Error .786
|
10.18 score on a scale
Standard Error .681
|
|
Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks
12-Week Follow-up
|
8.00 score on a scale
Standard Error .717
|
9.38 score on a scale
Standard Error .828
|
9.464 score on a scale
Standard Error .717
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all 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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=28 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=20 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=28 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up
Baseline
|
26.86 score on a scale
Standard Error 1.16
|
26.25 score on a scale
Standard Error 1.37
|
25.32 score on a scale
Standard Error 1.16
|
|
Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up
6-Week Follow-up
|
27.36 score on a scale
Standard Error 1.15
|
27.15 score on a scale
Standard Error 1.37
|
25.50 score on a scale
Standard Error 1.15
|
|
Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up
12-Week Follow-up
|
28.39 score on a scale
Standard Error 1.14
|
29.30 score on a scale
Standard Error 1.35
|
26.71 score on a scale
Standard Error 1.14
|
PRIMARY outcome
Timeframe: baseline, 6 weeks, 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all 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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=28 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=20 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=28 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up
Baseline
|
35.36 score on a scale
Standard Error 1.43
|
32.25 score on a scale
Standard Error 1.70
|
33.14 score on a scale
Standard Error 1.43
|
|
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up
6-Week Follow-up
|
36.43 score on a scale
Standard Error 1.27
|
35.20 score on a scale
Standard Error 1.50
|
32.68 score on a scale
Standard Error 1.27
|
|
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up
12-Week Follow-up
|
35.89 score on a scale
Standard Error 1.39
|
36.15 score on a scale
Standard Error 1.65
|
32.82 score on a scale
Standard Error 1.39
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
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.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=30 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=22 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=29 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Family Needs Questionnaire Baseline to 12-Week Follow-up
Baseline
|
40.63 score on a scale
Standard Error 1.79
|
37.18 score on a scale
Standard Error 2.09
|
37.93 score on a scale
Standard Error 1.82
|
|
Family Needs Questionnaire Baseline to 12-Week Follow-up
12-Week Follow-up
|
48.47 score on a scale
Standard Error 2.07
|
47.00 score on a scale
Standard Error 2.42
|
42.38 score on a scale
Standard Error 2.11
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
The Knowledge and Advocacy questionnaire assesses caregiver knowledge about FASD and advocacy and ranges from 0 to 28. Higher scores reflect greater knowledge.
Outcome measures
| Measure |
FMF Connect Intervention + Coaching
n=30 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=22 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=30 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
FASD Knowledge at Baseline and 12-Week Follow-up
Baseline
|
20.97 score on a scale
Standard Error .521
|
21.41 score on a scale
Standard Error .609
|
20.73 score on a scale
Standard Error .521
|
|
FASD Knowledge at Baseline and 12-Week Follow-up
12-Week Follow-up
|
21.30 score on a scale
Standard Error .566
|
22.36 score on a scale
Standard Error .661
|
20.30 score on a scale
Standard Error .566
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints.
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 + Coaching
n=30 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=22 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
n=30 Participants
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up
|
3.10 score on a scale
Standard Deviation 1.06
|
3.18 score on a scale
Standard Deviation .795
|
2.90 score on a scale
Standard Deviation .885
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Data was analyzed from participants with complete data on the measure from all timepoints. This measure is only applicable to arms that received the app.
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 + Coaching
n=29 Participants
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
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.
|
FMF Connect Intervention (no Coaching)
n=22 Participants
Participants receive the FMF Connect mobile health app. They do not receive coaching.
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.
|
Waitlist Comparison Group
Participants receive the FMF Connect mobile health app at the conclusion of the study.
|
|---|---|---|---|
|
Mean App Quality Score on Mobile App Rating Scale: User Version
|
4.13 score on a scale
Standard Deviation .39
|
4.24 score on a scale
Standard Deviation .32
|
—
|
Adverse Events
FMF Connect Intervention + Coaching
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FMF Connect Intervention (no Coaching)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Comparison Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Christie L. M. Petrenko, Ph.D.
Mt. Hope Family Center, University of Rochester
Phone: 5852752991
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place