search
Back to results

Efficacy Trial of the FMF Connect Mobile Health Intervention

Primary Purpose

Fetal Alcohol Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FMF Connect
Coaching
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Alcohol Spectrum Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

FMF Connect Intervention + Coaching

FMF Connect Intervention (no coaching)

Waitlist comparison group

Arm Description

Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.

Participants receive the FMF Connect mobile health app. They do not receive coaching.

Participants receive the FMF Connect mobile health app at the conclusion of the study.

Outcomes

Primary Outcome Measures

Mean Effect size in Eyberg Child Behavior Inventory
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
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
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
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
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
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
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
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.

Full Information

First Posted
August 24, 2021
Last Updated
January 9, 2023
Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05028517
Brief Title
Efficacy Trial of the FMF Connect Mobile Health Intervention
Official Title
Efficacy Trial of the FMF Connect Mobile Health Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMF Connect Intervention + Coaching
Arm Type
Experimental
Arm Description
Participants receive the FMF Connect mobile health app plus text-based coaching to support continued use of the app and individualized goal setting.
Arm Title
FMF Connect Intervention (no coaching)
Arm Type
Experimental
Arm Description
Participants receive the FMF Connect mobile health app. They do not receive coaching.
Arm Title
Waitlist comparison group
Arm Type
No Intervention
Arm Description
Participants receive the FMF Connect mobile health app at the conclusion of the study.
Intervention Type
Other
Intervention Name(s)
FMF Connect
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Coaching
Intervention Description
A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.
Primary Outcome Measure Information:
Title
Mean Effect size in Eyberg Child Behavior Inventory
Description
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.
Time Frame
baseline to 12 weeks
Title
Mean effect size in Reasons for Children's Behavior measure
Description
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.
Time Frame
baseline to 12 weeks
Title
Mean effect size in Parenting Sense of Competence scale for efficacy
Description
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.
Time Frame
baseline to 12 weeks
Title
Mean effect size in Parenting Sense of Competence scale for satisfaction
Description
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.
Time Frame
baseline to 12 weeks
Title
Mean effect size in Family Needs Questionnaire
Description
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.
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Mean effect size in FASD knowledge
Description
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.
Time Frame
baseline to 12 weeks
Title
Mean effect size in self-care confidence
Description
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.
Time Frame
baseline to 12 weeks
Title
Mean Mobile app rating tool
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is deposited quarterly into the Collaborative Initiative on Fetal Alcohol Spectrum Disorders central repository.
IPD Sharing Time Frame
It will be available once the data is collected and will be available indefinitely.
IPD Sharing URL
http://www.cifasd.org/data-sharing

Learn more about this trial

Efficacy Trial of the FMF Connect Mobile Health Intervention

We'll reach out to this number within 24 hrs