Feasibility Trial of the FMF Connect Mobile Health Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
FMF Connect Intervention
Intervention: FMF Connect (Other)
Outcomes
Primary Outcomes
Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up
Time Frame: 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.
Family Needs Questionnaire Baseline to 3-Month Follow-up
Time Frame: 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.
Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up
Time Frame: 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 - Efficacy Sub-scale Baseline to 3-Month Follow-up
Time Frame: 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.
Secondary Outcomes
- Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up(3-month follow-up)
- Mean App Quality Score on Mobile App Rating Scale: User Version(3-month follow-up)
Investigators
Christie Petrenko
Assistant Professor
University of Rochester