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| ID | Type | Description | Link |
|---|---|---|---|
| U01AA026104 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMF Connect Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMF Connect | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 3-month follow-up |
| 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. | baseline to 3-month follow-up |
| 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. | baseline to 3-month follow-up |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
Data is deposited quarterly into the Collaborative Initiative on Fetal Alcohol Spectrum Disorders central repository.
It will be available once the data is collected and will be available indefinitely.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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A total of 105 participants were assigned to study arm. 5 withdrew from the study. Demographic data was collected during eligibility screening and reflects all 100 participants. A total of 85 participants started or completed baseline surveys. 1 participant completed only some measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data was analyzed from participants with complete data on the measure from both timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline to 3-month follow-up |
|
3 months
Adverse events in children with FASD or their caregivers could include aggression or violence towards others, maltreatment, self-harm or suicidality, or the need for inpatient hospitalization. However, these occurrences are unlikely to be a direct consequence of participation in the caregiver intervention or study. These were not systematically assessed but procedures were in place to assess risk and respond appropriately if they arose.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FMF Connect Intervention | FMF Connect: The FMF Connect intervention includes cloud infrastructure and an innovative, multilayered mobile app. It incorporates tailored content for parents/caregivers of children (ages 3-12) with FASD or PAE. The app integrates five main components: 1) Dashboard; 2) Learning Modules; 3) Family Forum; 4) Library; and 5) Notebook. Weekly emails are also sent to support motivational engagement. |
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This study was designed to assess intervention and trial feasibility rather than test efficacy. Effect sizes were calculate to estimate sensitive of selected measures to change and inform refinements prior to RCT. Also note, Android participants completed study procedures almost a year later than iOS due to COVID-19 pandemic-related project delays.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christie Petrenko | Mt. Hope Family Center, University of Rochester | (585) 275-2991 | 241 | christie.petrenko@rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 | Jul 22, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2020 | Aug 22, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D063647 | Fetal Alcohol Spectrum Disorders |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| baseline to 3-month follow-up |
| 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. . | 3-month follow-up |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Relationship to Child | A total of 8 participants belonged to multiple categories. | Number | participants |
|
| Phone Operating System | Count of Participants | Participants |
|
| Child Age | Mean | Standard Deviation | years |
|
| Child Sex at Birth | Count of Participants | Participants |
|
| Child Race | Count of Participants | Participants |
|
| Child Ethnicity | Count of Participants | Participants |
|
| Eyberg Child Behavior Inventory - Intensity | Data presented includes all of those with baseline data collection for this measure. | Mean | Standard Deviation | units on a scale |
|
| Parenting Sense of Competence Scale - Efficacy | Data presented is only from participants who have complete data for this measure. | Mean | Standard Deviation | units on a scale |
|
| Parenting Sense of Competence Scale - Satisfaction | Data presented includes only those participants who have complete data for this measure. | Mean | Standard Deviation | units on a scale |
|
| Family Needs Met Scale | Data is presented for participants with complete data on this measure. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from both timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline to 3-month follow-up |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from both timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline to 3-month follow-up |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from both timepoints. | Posted | Mean | Standard Deviation | score on a scale | baseline to 3-month follow-up |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure at the 3-month follow-up timepoint. | Posted | Mean | Standard Deviation | score on a scale | 3-month follow-up |
|
|
|
| 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. . | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-month follow-up |
|
|
|
| 0 |
| 105 |
| 0 |
| 105 |
| 0 |
| 105 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |