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.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Rochester
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 with iOS or Android operating system
Exclusion criteria
* The parent/caregiver is not fluent in English (the FMF Connect app and pre-post measures are currently only available in English) * There is another parent/caregiver of the same child or living in the home that is already enrolled in the study (couples are excluded to prevent dependence in the data) * The family has previously received or is currently receiving the therapist-led Families Moving Forward (FMF) Program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up | baseline to 3-month follow-up | The Eyberg Child Behavior Inventory measures the intensity of child behavior problems. Scores are presented as T-scores with a mean of 50 and a standard deviation of 10. A T-score of 60 or higher is considered clinically significant. Higher scores indicate more intense behavior problems. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. |
| Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up | baseline to 3-month follow-up | The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The satisfaction sub-scale reported here includes 9 items, rated on a scale from 1 (strongly agree) to 6 (strongly disagree). Responses are summed, with possible sub-scale score range from 9 to 54 with higher scores indicating higher satisfaction in the parenting role. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. |
| Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up | baseline to 3-month follow-up | The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The efficacy sub-scale reported here measures how effective parents feel they are and includes 7 items, rated on a scale from 1 (strongly agree) to 6 (strongly disagree). Responses are summed, with possible sub-scale score range from 7 to 42 with higher scores indicating lower feelings of efficacy. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. |
| Family Needs Questionnaire Baseline to 3-Month Follow-up | baseline to 3-month follow-up | The family needs questionnaire measures the degree to which family needs are met. The scale includes 20 items reflecting family needs that are rated on a scale from 0 to 4, with 0 being not applicable to 4 being met a great deal. The total score on this measure is created by averaging across all items. Total score ranges from 0-4. Higher scores reflect more needs being met. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up | 3-month follow-up | Participants are asked at follow-up to rate how much their self-care practices have changed over the last 3 months on a 5-point scale ranging from A lot less self-care (1) to A lot more self-care (5). A score of 3 equates to no change. |
| Mean App Quality Score on Mobile App Rating Scale: User Version | 3-month follow-up | 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. . |
Countries
United States
Participant flow
Pre-assignment details
Participants were asked to complete an eConsent and several screening questionnaires in REDCap. A total of 66 did not proceed to assignment to study arm for the following reasons: 24 did not meet eligibility criteria, 38 had incomplete data so eligibility was not able to be determined, 3 chose to wait for the subsequent RCT, and 1 was overlooked due to study team error.
Participants by arm
| Arm | Count |
|---|---|
| FMF Connect Intervention FMF Connect: The FMF Connect intervention includes cloud infrastructure and an innovative, multilayered mobile app. It incorporates tailored content for parents/caregivers of children (ages 3-12) with FASD or PAE. The app integrates five main components: 1) Dashboard; 2) Learning Modules; 3) Family Forum; 4) Library; and 5) Notebook. Weekly emails are also sent to support motivational engagement. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 48 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | FMF Connect Intervention |
|---|---|
| Age, Continuous | 46.48 Years STANDARD_DEVIATION 8.72 |
| Child Age | 8.09 years STANDARD_DEVIATION 2.62 |
| Child Ethnicity Hispanic / Latinx | 16 Participants |
| Child Ethnicity Not Hispanic / Latinx | 80 Participants |
| Child Ethnicity Unknown | 4 Participants |
| Child Race African American / Black | 6 Participants |
| Child Race Asian | 2 Participants |
| Child Race More Than One Race | 23 Participants |
| Child Race Native American / Alaska Native | 6 Participants |
| Child Race Native Hawaiian / Pacific Islander | 1 Participants |
| Child Race Unknown | 3 Participants |
| Child Race White | 59 Participants |
| Child Sex at Birth Female | 39 Participants |
| Child Sex at Birth Male | 61 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Eyberg Child Behavior Inventory - Intensity | 69.75 units on a scale STANDARD_DEVIATION 8.94 |
| Family Needs Met Scale | 2.35 units on a scale STANDARD_DEVIATION 0.67 |
| Parenting Sense of Competence Scale - Efficacy | 21.17 units on a scale STANDARD_DEVIATION 5.48 |
| Parenting Sense of Competence Scale - Satisfaction | 34.29 units on a scale STANDARD_DEVIATION 6.43 |
| Phone Operating System Android | 38 Participants |
| Phone Operating System Apple iOS | 62 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 92 Participants |
| Region of Enrollment United States | 100 participants |
| Relationship to Child Adoptive Parent | 83 participants |
| Relationship to Child Biological Parent | 3 participants |
| Relationship to Child Foster Parent | 7 participants |
| Relationship to Child Grandparent | 7 participants |
| Relationship to Child Other Relative | 8 participants |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 105 |
| other Total, other adverse events | 0 / 105 |
| serious Total, serious adverse events | 0 / 105 |
Outcome results
Primary
Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up
The Eyberg Child Behavior Inventory measures the intensity of child behavior problems. Scores are presented as T-scores with a mean of 50 and a standard deviation of 10. A T-score of 60 or higher is considered clinically significant. Higher scores indicate more intense behavior problems. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Time frame: baseline to 3-month follow-up
Population: Data was analyzed from participants with complete data on the measure from both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention | Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up | Baseline | 69.31 score on a scale | Standard Deviation 9.29 |
| FMF Connect Intervention | Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up | Follow-up | 65.62 score on a scale | Standard Deviation 7.81 |
Comparison: Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Primary
Family Needs Questionnaire Baseline to 3-Month Follow-up
The family needs questionnaire measures the degree to which family needs are met. The scale includes 20 items reflecting family needs that are rated on a scale from 0 to 4, with 0 being not applicable to 4 being met a great deal. The total score on this measure is created by averaging across all items. Total score ranges from 0-4. Higher scores reflect more needs being met. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Time frame: baseline to 3-month follow-up
Population: Data was analyzed from participants with complete data on the measure from both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention | Family Needs Questionnaire Baseline to 3-Month Follow-up | Baseline | 2.34 score on a scale | Standard Deviation 0.71 |
| FMF Connect Intervention | Family Needs Questionnaire Baseline to 3-Month Follow-up | Follow-up | 2.35 score on a scale | Standard Deviation 0.57 |
Comparison: Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Primary
Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The efficacy sub-scale reported here measures how effective parents feel they are and includes 7 items, rated on a scale from 1 (strongly agree) to 6 (strongly disagree). Responses are summed, with possible sub-scale score range from 7 to 42 with higher scores indicating lower feelings of efficacy. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Time frame: baseline to 3-month follow-up
Population: Data was analyzed from participants with complete data on the measure from both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention | Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up | Baseline | 22.04 score on a scale | Standard Deviation 6.01 |
| FMF Connect Intervention | Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up | Follow-up | 20.56 score on a scale | Standard Deviation 4.8 |
Comparison: Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Primary
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up
The Parenting sense of competence scale includes two sub-scales: 1) satisfaction and 2) efficacy. The satisfaction sub-scale reported here includes 9 items, rated on a scale from 1 (strongly agree) to 6 (strongly disagree). Responses are summed, with possible sub-scale score range from 9 to 54 with higher scores indicating higher satisfaction in the parenting role. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Time frame: baseline to 3-month follow-up
Population: Data was analyzed from participants with complete data on the measure from both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FMF Connect Intervention | Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up | Baseline | 32.90 score on a scale | Standard Deviation 6.18 |
| FMF Connect Intervention | Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up | Follow-up | 34.02 score on a scale | Standard Deviation 7.18 |
Comparison: Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
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: 3-month follow-up
Population: Data was analyzed from participants with complete data on the measure at the 3-month follow-up timepoint. Data was missing for 2 participants on this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FMF Connect Intervention | Mean App Quality Score on Mobile App Rating Scale: User Version | 4.08 score on a scale | Standard Deviation 0.47 |
Secondary
Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up
Participants are asked at follow-up to rate how much their self-care practices have changed over the last 3 months on a 5-point scale ranging from A lot less self-care (1) to A lot more self-care (5). A score of 3 equates to no change.
Time frame: 3-month follow-up
Population: Data was analyzed from participants with complete data on the measure at the 3-month follow-up timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FMF Connect Intervention | Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up | 2.92 score on a scale | Standard Deviation 1.22 |