Efficacy Trial of the FMF Connect Mobile Health Intervention
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: 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.
Other: Coaching
A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.
|
| Experimental: FMF Connect Intervention (no coaching) Participants receive the FMF Connect mobile health app. They do not receive coaching. |
Other: 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.
|
| No Intervention: Waitlist comparison group Participants receive the FMF Connect mobile health app at the conclusion of the study. |
Outcome Measures
Primary Outcome Measures
- Mean Effect size in Eyberg Child Behavior Inventory [baseline to 12 weeks]
The Eyberg Child Behavior Inventory measures the intensity of child behavior problems, scores have a mean of 50 and a standard deviation of 10 with higher scores indicating worse outcomes. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean effect size in Reasons for Children's Behavior measure [baseline to 12 weeks]
The Reasons for Children's Behavior measure assesses parents attributions of behavior and ranges from 30 to 180 with higher scores reflecting greater agreement with neurodevelopmental attributions. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean effect size in Parenting Sense of Competence scale for efficacy [baseline to 12 weeks]
The Parenting sense of competence scale measures how effective parents feel they are and ranges from 7 to 42 with higher scores indicating worse outcomes. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean effect size in Parenting Sense of Competence scale for satisfaction [baseline to 12 weeks]
The Parenting sense of competence scale measures satisfaction with parenting and ranges from 9 to 54 with higher scores indicating better outcomes. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean effect size in Family Needs Questionnaire [baseline to 12 weeks]
The family needs questionnaire measures the degree to which family needs are met and ranges from 0-4 with 4 indicating more needs are met. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
Secondary Outcome Measures
- Mean effect size in FASD knowledge [baseline to 12 weeks]
The Knowledge and Advocacy questionnaire assesses caregiver knowledge about FASD and advocacy and ranges from 0 to 30. Higher scores reflect greater knowledge. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean effect size in self-care confidence [baseline to 12 weeks]
The self-care confidence scale ranges from 1-5 with 5 indicating greater confidence in self-care. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.
- Mean Mobile app rating tool [12 weeks]
The mobile app tool measures users perception of app quality and ranges from 4-20 with higher scores reflecting greater perceived quality of the app.
Eligibility Criteria
Criteria
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 or ipad with iOS 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
Sponsors and Collaborators
- University of Rochester
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00006555
- U01AA026104