Fetal Alcohol Spectrum Disorders
Conditions
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.
Interventions
OTHERFMF 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.
OTHERCoaching
A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This study involves a three arm randomized controlled trial with equal allocation to the following conditions: (1) FMF Connect + coaching, (2) FMF Connect alone, and (3) waitlist control. Quantitative survey data will be collected at three timepoints: baseline (T1), 6-weeks (T2), and 12-weeks (T3).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 - The caregiver participated in a prior trial of the FMF Connect app as part of earlier development phases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FASD Knowledge at Baseline and 12-Week Follow-up | baseline to 12 weeks | The Knowledge and Advocacy questionnaire assesses caregiver knowledge about FASD and advocacy and ranges from 0 to 28. Higher scores reflect greater knowledge. |
| Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up | baseline, 6 weeks, 12 weeks | 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. |
| Family Needs Questionnaire Baseline to 12-Week Follow-up | baseline to 12 weeks | 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. |
| Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up | baseline to 12 weeks | 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. |
| Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks | baseline, 6 weeks, 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. |
| Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks | baseline, 6 weeks, 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. |
| Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks | baseline, 6 weeks, 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. |
| Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks | baseline, 6 weeks, 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. |
| Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | baseline, 6 weeks, 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. |
| Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks | baseline, 6 weeks, 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. |
| Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | baseline, 6 weeks, 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. |
| Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up | baseline, 6 weeks, 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean App Quality Score on Mobile App Rating Scale: User Version | 12 weeks | 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. |
| Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up | 12 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 43 |
| Waitlist Comparison Group Participants receive the FMF Connect mobile health app at the conclusion of the study. | 43 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 20 | 12 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | FMF Connect Intervention (no Coaching) | Waitlist Comparison Group | Total | FMF Connect Intervention + Coaching |
|---|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 7.6 | 43.7 years STANDARD_DEVIATION 7.6 | 44.00 years STANDARD_DEVIATION 7.38 | 45.2 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 40 Participants | 124 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Eyberg Child Behavior Inventory - Intensity Scale | 69.51 T-score STANDARD_DEVIATION 7.14 | 68.28 T-score STANDARD_DEVIATION 9.01 | 69.00 T-score STANDARD_DEVIATION 8.33 | 69.20 T-score STANDARD_DEVIATION 8.86 |
| Family Needs Met Scale | 38.64 units on a scale STANDARD_DEVIATION 10.77 | 38.44 units on a scale STANDARD_DEVIATION 9.62 | 39.02 units on a scale STANDARD_DEVIATION 10.17 | 39.93 units on a scale STANDARD_DEVIATION 10.28 |
| Knowledge and Advocacy Scale | 20.97 units on a scale STANDARD_DEVIATION 3.38 | 20.77 units on a scale STANDARD_DEVIATION 3.65 | 20.76 units on a scale STANDARD_DEVIATION 3.2 | 20.56 units on a scale STANDARD_DEVIATION 2.59 |
| Parenting Sense of Competence Scale - Efficacy | 26.77 units on a scale STANDARD_DEVIATION 5.18 | 25.23 units on a scale STANDARD_DEVIATION 6.58 | 26.27 units on a scale STANDARD_DEVIATION 5.79 | 26.78 units on a scale STANDARD_DEVIATION 5.56 |
| Parenting Sense of Competence Scale - Satisfaction | 34.05 units on a scale STANDARD_DEVIATION 7.85 | 33.41 units on a scale STANDARD_DEVIATION 6.98 | 33.87 units on a scale STANDARD_DEVIATION 7.2 | 34.12 units on a scale STANDARD_DEVIATION 6.93 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 00 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 41 Participants | 39 Participants | 120 Participants | 40 Participants |
| Reasons for Children's Behavior Scale - Disruptive Behavior | 15.36 units on a scale STANDARD_DEVIATION 6.32 | 15.26 units on a scale STANDARD_DEVIATION 7.37 | 15.56 units on a scale STANDARD_DEVIATION 6.61 | 16.10 units on a scale STANDARD_DEVIATION 6.24 |
| Reasons for Children's Behavior Scale - Dysregulated | 9.56 units on a scale STANDARD_DEVIATION 3.43 | 8.79 units on a scale STANDARD_DEVIATION 3.57 | 9.06 units on a scale STANDARD_DEVIATION 3.62 | 8.83 units on a scale STANDARD_DEVIATION 3.87 |
| Reasons for Children's Behavior Scale - Emotional Support | 20.82 units on a scale STANDARD_DEVIATION 3.04 | 20.90 units on a scale STANDARD_DEVIATION 3.55 | 20.45 units on a scale STANDARD_DEVIATION 3.52 | 19.68 units on a scale STANDARD_DEVIATION 3.86 |
| Reasons for Children's Behavior Scale - Sensory Avoid | 19.18 units on a scale STANDARD_DEVIATION 5.99 | 15.64 units on a scale STANDARD_DEVIATION 6.06 | 16.99 units on a scale STANDARD_DEVIATION 5.95 | 16.20 units on a scale STANDARD_DEVIATION 5.32 |
| Reasons for Children's Behavior Scale - Sensory Seek | 23.90 units on a scale STANDARD_DEVIATION 4.98 | 22.56 units on a scale STANDARD_DEVIATION 6.69 | 23.20 units on a scale STANDARD_DEVIATION 6.06 | 23.15 units on a scale STANDARD_DEVIATION 6.43 |
| Reasons for Children's Behavior Scale - Task Ability | 23.67 units on a scale STANDARD_DEVIATION 4.53 | 22.13 units on a scale STANDARD_DEVIATION 4.26 | 23.57 units on a scale STANDARD_DEVIATION 4.46 | 22.95 units on a scale STANDARD_DEVIATION 4.61 |
| Reasons for Children's Behavior Scale - Task Willful | 10.51 units on a scale STANDARD_DEVIATION 2.89 | 10.05 units on a scale STANDARD_DEVIATION 3.33 | 10.36 units on a scale STANDARD_DEVIATION 3.11 | 10.51 units on a scale STANDARD_DEVIATION 3.15 |
| Region of Enrollment United States | 43 participants | 43 participants | 129 participants | 43 participants |
| Sex: Female, Male Female | 41 Participants | 40 Participants | 124 Participants | 43 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 0 / 43 | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 | 0 / 43 |
Outcome results
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.
Time frame: baseline to 12 weeks
Population: Data was analyzed from participants with complete data on the measure from both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up | Baseline | 68.33 T-score | Standard Error 1.65 |
| FMF Connect Intervention + Coaching | Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up | 12-week Follow-up | 64.47 T-score | Standard Error 1.67 |
| FMF Connect Intervention (no Coaching) | Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up | Baseline | 69.13 T-score | Standard Error 1.88 |
| FMF Connect Intervention (no Coaching) | Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up | 12-week Follow-up | 65.87 T-score | Standard Error 1.9 |
| Waitlist Comparison Group | Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up | Baseline | 68.40 T-score | Standard Error 1.65 |
| Waitlist Comparison Group | Eyberg Child Behavior Inventory - Intensity at Baseline and 12-week Follow-Up | 12-week Follow-up | 66.03 T-score | Standard Error 1.67 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.602ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Full information maximum likelihood (FMIL) was used for missing data in MPlus. Baseline and FMF Connect group status were entered into the regression model simultaneously. The dependent variable entered was the measure at the 12-week follow-up to determine treatment effects.p-value: 0.3395% CI: [-0.69, 0.23]Regression, Linear
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.
Time frame: baseline to 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | Family Needs Questionnaire Baseline to 12-Week Follow-up | Baseline | 40.63 score on a scale | Standard Error 1.79 |
| FMF Connect Intervention + Coaching | Family Needs Questionnaire Baseline to 12-Week Follow-up | 12-Week Follow-up | 48.47 score on a scale | Standard Error 2.07 |
| FMF Connect Intervention (no Coaching) | Family Needs Questionnaire Baseline to 12-Week Follow-up | Baseline | 37.18 score on a scale | Standard Error 2.09 |
| FMF Connect Intervention (no Coaching) | Family Needs Questionnaire Baseline to 12-Week Follow-up | 12-Week Follow-up | 47.00 score on a scale | Standard Error 2.42 |
| Waitlist Comparison Group | Family Needs Questionnaire Baseline to 12-Week Follow-up | Baseline | 37.93 score on a scale | Standard Error 1.82 |
| Waitlist Comparison Group | Family Needs Questionnaire Baseline to 12-Week Follow-up | 12-Week Follow-up | 42.38 score on a scale | Standard Error 2.11 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.257ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Full information maximum likelihood (FMIL) was used for missing data in MPlus. Baseline and FMF Connect group status were entered into the regression model simultaneously. The dependent variable entered was the measure at the 12-week follow-up to determine treatment effects.p-value: 0.03995% CI: [-0.02, 0.94]Regression, Linear
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.
Time frame: baseline to 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | FASD Knowledge at Baseline and 12-Week Follow-up | Baseline | 20.97 score on a scale | Standard Error 0.521 |
| FMF Connect Intervention + Coaching | FASD Knowledge at Baseline and 12-Week Follow-up | 12-Week Follow-up | 21.30 score on a scale | Standard Error 0.566 |
| FMF Connect Intervention (no Coaching) | FASD Knowledge at Baseline and 12-Week Follow-up | Baseline | 21.41 score on a scale | Standard Error 0.609 |
| FMF Connect Intervention (no Coaching) | FASD Knowledge at Baseline and 12-Week Follow-up | 12-Week Follow-up | 22.36 score on a scale | Standard Error 0.661 |
| Waitlist Comparison Group | FASD Knowledge at Baseline and 12-Week Follow-up | Baseline | 20.73 score on a scale | Standard Error 0.521 |
| Waitlist Comparison Group | FASD Knowledge at Baseline and 12-Week Follow-up | 12-Week Follow-up | 20.30 score on a scale | Standard Error 0.566 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.192ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Full information maximum likelihood (FMIL) was used for missing data in MPlus. Baseline and FMF Connect group status were entered into the regression model simultaneously. The dependent variable entered was the measure at the 12-week follow-up to determine treatment effects.p-value: 0.03995% CI: [0.02, 0.93]Regression, Linear
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention (no Coaching) | Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up | 6-Week Follow-up | 27.15 score on a scale | Standard Error 1.37 |
| FMF Connect Intervention (no Coaching) | Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up | Baseline | 26.25 score on a scale | Standard Error 1.37 |
| FMF Connect Intervention (no Coaching) | Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up | 12-Week Follow-up | 29.30 score on a scale | Standard Error 1.35 |
| Waitlist Comparison Group | Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up | Baseline | 25.32 score on a scale | Standard Error 1.16 |
| Waitlist Comparison Group | Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up | 12-Week Follow-up | 26.71 score on a scale | Standard Error 1.14 |
| Waitlist Comparison Group | Parenting Sense of Competence - Efficacy Sub-scale Baseline, 6-Week, and 12-Week Follow-up | 6-Week Follow-up | 25.50 score on a scale | Standard Error 1.15 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.468ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.p-value: 0.683Mixed Models Analysis
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention (no Coaching) | Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up | 6-Week Follow-up | 35.20 score on a scale | Standard Error 1.5 |
| FMF Connect Intervention (no Coaching) | Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up | Baseline | 32.25 score on a scale | Standard Error 1.7 |
| FMF Connect Intervention (no Coaching) | Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up | 12-Week Follow-up | 36.15 score on a scale | Standard Error 1.65 |
| Waitlist Comparison Group | Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up | Baseline | 33.14 score on a scale | Standard Error 1.43 |
| Waitlist Comparison Group | Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up | 12-Week Follow-up | 32.82 score on a scale | Standard Error 1.39 |
| Waitlist Comparison Group | Parenting Sense of Competence - Satisfaction Sub-scale at Baseline, 6-Week, 12-Week Follow-up | 6-Week Follow-up | 32.68 score on a scale | Standard Error 1.27 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.01ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.p-value: 0.131Mixed Models Analysis
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 13.81 score on a scale | Standard Error 1.35 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 17.05 score on a scale | Standard Error 1.47 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | 12 Week Follow-up | 13.24 score on a scale | Standard Error 1.45 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 15.29 score on a scale | Standard Error 1.28 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | 12 Week Follow-up | 14.75 score on a scale | Standard Error 1.25 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Disruptive Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 15.50 score on a scale | Standard Error 1.17 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.038ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.p-value: 0.084Mixed Models Analysis
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 0.681 |
| FMF Connect Intervention + Coaching | Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 8.36 score on a scale | Standard Error 0.709 |
| FMF Connect Intervention + Coaching | 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 0.717 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 10.76 score on a scale | Standard Error 0.786 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 9.48 score on a scale | Standard Error 0.819 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 9.38 score on a scale | Standard Error 0.828 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 8.964 score on a scale | Standard Error 0.709 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 9.464 score on a scale | Standard Error 0.717 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Dysregulated Behavior Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 10.18 score on a scale | Standard Error 0.681 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.671ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.p-value: 0.19Mixed Models Analysis
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 21.43 score on a scale | Standard Error 0.697 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 20.29 score on a scale | Standard Error 0.859 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 20.91 score on a scale | Standard Error 0.735 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 20.79 score on a scale | Standard Error 0.744 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 21.32 score on a scale | Standard Error 0.636 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Emotional Support Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 21.43 score on a scale | Standard Error 0.603 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.94ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.p-value: 0.961Mixed Models Analysis
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 19.29 score on a scale | Standard Error 1.45 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 18.91 score on a scale | Standard Error 1.17 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 17.29 score on a scale | Standard Error 1.49 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 16.57 score on a scale | Standard Error 1.01 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 17.57 score on a scale | Standard Error 1.29 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Sensory Avoid Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 18.25 score on a scale | Standard Error 1.25 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.294ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data in SPSS. Analyses utilized linear mixed modeling for variables collected at the three timepoints.p-value: 0.524Mixed Models Analysis
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 25.43 score on a scale | Standard Error 1.17 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 23.24 score on a scale | Standard Error 1.23 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 24.76 score on a scale | Standard Error 1.37 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 23.29 score on a scale | Standard Error 1.06 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 23.14 score on a scale | Standard Error 1.19 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Sensory Seek Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 24.39 score on a scale | Standard Error 1.02 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.039ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.p-value: 0.548Mixed Models Analysis
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 22.77 score on a scale | Standard Error 0.862 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 22.48 score on a scale | Standard Error 0.978 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 21.57 score on a scale | Standard Error 1.07 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 24.32 score on a scale | Standard Error 0.847 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 23.68 score on a scale | Standard Error 0.922 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 24.57 score on a scale | Standard Error 0.746 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.672ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.p-value: 0.463Mixed Models Analysis
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.
Time frame: baseline, 6 weeks, 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 9.86 score on a scale | Standard Error 0.608 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 10.67 score on a scale | Standard Error 0.665 |
| FMF Connect Intervention (no Coaching) | Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 8.57 score on a scale | Standard Error 0.665 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks | Baseline | 10.43 score on a scale | Standard Error 0.576 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks | 12-Week Follow-up | 10.46 score on a scale | Standard Error 0.576 |
| Waitlist Comparison Group | Reasons for Children's Behavior - Task Willful Subscale at Baseline, 6-Weeks, and 12-Weeks | 6-Week Follow-up | 10.89 score on a scale | Standard Error 0.527 |
Comparison: Mean comparisons of 3 separate groups using repeated measures ANOVA, including baseline, 6 week, and 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.032ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Multiple imputation was used for missing data. Analyses utilized linear mixed modeling for variables collected at the three timepoints.p-value: 0.013Mixed Models Analysis
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FMF Connect Intervention + Coaching | Mean App Quality Score on Mobile App Rating Scale: User Version | 4.13 score on a scale | Standard Deviation 0.39 |
| FMF Connect Intervention (no Coaching) | Mean App Quality Score on Mobile App Rating Scale: User Version | 4.24 score on a scale | Standard Deviation 0.32 |
p-value: 0.255ANOVA
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.
Time frame: 12 weeks
Population: Data was analyzed from participants with complete data on the measure from all timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FMF Connect Intervention + Coaching | 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 |
| FMF Connect Intervention (no Coaching) | Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up | 3.18 score on a scale | Standard Deviation 0.795 |
| Waitlist Comparison Group | Participant Perception of Self-care Change Over Intervention Period Reported at 12-week Follow-up | 2.90 score on a scale | Standard Deviation 0.885 |
Comparison: Mean comparisons of 3 separate groups using ANOVA for 12 week data. Participants with missing data were excluded. All participants were retained in their originally assigned group regardless of app usage.p-value: 0.524ANOVA
Comparison: The FMF Connect + Coaching and FMF Connect groups were aggregated for analyses. Analyses were intent-to-treat, including all participants assigned to condition. Full information maximum likelihood (FMIL) was used for missing data in MPlus. The dependent variable entered was the measure at the 12-week follow-up to determine treatment effects.p-value: 0.04895% CI: [0, 0.91]Regression, Linear