Fetal Alcohol Spectrum Disorders Clinical Trial
Official title:
Feasibility Trial of the FMF Connect Mobile Health Intervention
Verified date | December 2023 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 171 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | baseline to 3-month follow-up | |
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. | 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. | 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. | 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. | 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. . | 3-month follow-up |
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