Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT04194489
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 183
• Location: 1
• Arm: 1
• Actual Duration (Months): 18
• Patients Per Site Per Month: 10.2

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
Fetal Alcohol Spectrum Disorders	Other: FMF Connect	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility Trial of the FMF Connect Mobile Health Intervention
• Actual Study Start Date: Jan 31, 2020
• Actual Primary Completion Date: Jul 31, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: FMF Connect Intervention

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.

Outcome Measures

Primary Outcome Measures

1. Mean Effect size in Eyberg Child Behavior Inventory [baseline to 3 months]

   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.

2. Mean effect size in Parenting Sense of Competence scale for satisfaction [baseline to 3 months]

   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.

3. Mean effect size in Parenting Sense of Competence scale for efficacy [baseline to 3 months]

   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.

4. Mean effect size in Family Needs Questionnaire [baseline to 3 months]

   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

1. Mean effect size in self-care confidence [baseline to 3 months]

   The self-care confidence scale ranges from 1-5 with 5 indicating greater confidence in self-care.

2. Mean Mobile app rating tool [3 months]

   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

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

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.

• Responsible Party: Christie Petrenko, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT04194489
• Other Study ID Numbers: 4433; U01AA026104
• First Posted: Dec 11, 2019
• Last Update Posted: Aug 16, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fetal Alcohol Spectrum Disorders

Study Results

No Results Posted as of Aug 16, 2021