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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 + Coaching | Experimental | 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 Intervention (no coaching) | Experimental | Participants receive the FMF Connect mobile health app. They do not receive coaching. |
|
| Waitlist comparison group | No Intervention | Participants receive the FMF Connect mobile health app at the conclusion of the study. |
| 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 - 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. | baseline to 12 weeks |
| 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. | baseline, 6 weeks, 12 weeks |
| 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. | baseline, 6 weeks, 12 weeks |
| 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. | baseline, 6 weeks, 12 weeks |
| Reasons for Children's Behavior - Task Ability Subscale at Baseline, 6-Weeks, and 12-Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Waitlist Comparison Group | Participants receive the FMF Connect mobile health app at the conclusion of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 129 participants enrolled in the study and were allocated to the 3 arms. Demographic variables were provided at study enrollment. Data is available for demographics (age, sex, race, ethnicity, region) for 129 participants (43 per study arm). 10 participants did not complete baseline surveys, resulting in 119 participants with data for survey measures (Eyberg Child Behavior Inventory, Reasons for Children's Behavior, Parenting Sense of Competence, Family Needs Met, FASD Knowledge).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 - 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. | Data was analyzed from participants with complete data on the measure from both timepoints. | Posted | Mean | Standard Error | T-score | baseline to 12 weeks |
|
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 + 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christie L. M. Petrenko, Ph.D. | Mt. Hope Family Center, University of Rochester | 5852752991 | 241 | christie_petrenko@urmc.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 | Dec 13, 2021 | Dec 1, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 9, 2022 | Dec 1, 2023 | 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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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).
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|
| Coaching | Other | A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting. |
|
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.
| baseline, 6 weeks, 12 weeks |
| 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. | baseline, 6 weeks, 12 weeks |
| 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. | baseline, 6 weeks, 12 weeks |
| 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. | baseline, 6 weeks, 12 weeks |
| 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. | baseline, 6 weeks, 12 weeks |
| 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. | baseline, 6 weeks, 12 weeks |
| 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. | baseline to 12 weeks |
| 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. | baseline to 12 weeks |
| 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. | 12 weeks |
| BG001 | 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. |
| BG002 | Waitlist Comparison Group | Participants receive the FMF Connect mobile health app at the conclusion of the study. |
| BG003 | Total | Total of all reporting groups |
| 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 |
|
| Eyberg Child Behavior Inventory - Intensity Scale | 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. | 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. | Mean | Standard Deviation | T-score |
|
| Reasons for Children's Behavior Scale - Sensory Avoid | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Reasons for Children's Behavior Scale - Sensory Seek | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Reasons for Children's Behavior Scale - Task Willful | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Reasons for Children's Behavior Scale - Task Ability | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Reasons for Children's Behavior Scale - Disruptive Behavior | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Reasons for Children's Behavior Scale - Emotional Support | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Reasons for Children's Behavior Scale - Dysregulated | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Parenting Sense of Competence Scale - Efficacy | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Parenting Sense of Competence Scale - Satisfaction | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Family Needs Met Scale | 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. | 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. | Mean | Standard Deviation | units on a scale |
|
| Knowledge and Advocacy Scale | The Knowledge and Advocacy questionnaire assesses caregiver knowledge about FASD and advocacy and ranges from 0 to 28. Higher scores reflect greater knowledge. | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
| OG002 | Waitlist Comparison Group | Participants receive the FMF Connect mobile health app at the conclusion of the study. |
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline, 6 weeks, 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Error | score on a scale | baseline to 12 weeks |
|
|
|
|
| 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. | Data was analyzed from participants with complete data on the measure from all timepoints. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 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 from all timepoints. This measure is only applicable to arms that received the app. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | 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. | 0 | 43 | 0 | 43 | 0 | 43 |
| EG002 | Waitlist Comparison Group | Participants receive the FMF Connect mobile health app at the conclusion of the study. | 0 | 43 | 0 | 43 | 0 | 43 |
Not provided
Not provided
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| 12-Week Follow-up |
|
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. |
| Mixed Models Analysis |
F(2) = .652 |
| .524 |
False discovery rate (FDR) correction for multiple comparisons, p=.602 |
| Superiority |
|
| 12-Week Follow-up |
|
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. |
| Mixed Models Analysis |
F(2) = .606 |
| .548 |
False discovery rate (FDR) correction for multiple comparisons, p=.893 |
| Superiority |
|
| 12-Week Follow-up |
|
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. |
| Mixed Models Analysis |
F(2) = 4.595 |
| .013 |
False discovery rate (FDR) correction for multiple comparisons, p=.143 |
| Superiority |
|
| 12-Week Follow-up |
|
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. |
| Mixed Models Analysis |
F(2) = .776 |
| .463 |
False discovery rate (FDR) correction for multiple comparisons, p=.893 |
| Superiority |
|
| 12 Week Follow-up |
|
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. |
| Mixed Models Analysis |
F(2) = 2.544 |
| .084 |
False discovery rate (FDR) correction for multiple comparisons, p=.462 |
| Superiority |
|
| 12-Week Follow-up |
|
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. |
| Mixed Models Analysis |
F(2) = .040 |
| .961 |
False discovery rate (FDR) correction for multiple comparisons, p=.961 |
| Superiority |
|
| 12-Week Follow-up |
|
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. |
| Mixed Models Analysis |
F(2)=1.696 |
| .190 |
False discovery rate (FDR) correction for multiple comparisons, p=.523 |
| Superiority |
|
| 12-Week Follow-up |
|
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. |
| Mixed Models Analysis |
F(2) = .384 |
| .683 |
False discovery rate (FDR) correction for multiple comparisons, p=.817 |
| Superiority |
|
| 12-Week Follow-up |
|
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. |
| Mixed Models Analysis |
F(2)=2.081 |
| .131 |
False discovery rate (FDR) correction for multiple comparisons, p=.480 |
| Superiority |
|
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. |
| Regression, Linear |
| .039 |
False discovery rate (FDR) correction for multiple comparisons, p=.055 |
| Cohen's d |
| 0.49 |
| 2-Sided |
| 95 |
| -0.02 |
| 0.94 |
| Superiority |
|
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. |
| Regression, Linear |
| .039 |
False discovery rate (FDR) correction for multiple comparisons, p=.055 |
| Cohen's d |
| 0.47 |
| 2-Sided |
| 95 |
| 0.02 |
| 0.93 |
| Superiority |
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. |
| Regression, Linear |
| .048 |
False discovery rate (FDR) correction for multiple comparisons, p=.066 |
| Cohen's d |
| 0.46 |
| 2-Sided |
| 95 |
| 0.00 |
| 0.91 |
| Superiority |